Dietary Triggers of Gastrointestinal Symptoms in IBS Patients

March 12, 2026 updated by: Premysl Bercik, McMaster University

Crossover Trial of Purified Gluten and Whole Wheat (Gluten With Amylase-trypsin Inhibitors) as Triggers of Gastrointestinal Symptoms in Patients With Irritable Bowel Syndrome

This crossover randomized controlled trial will evaluate the effects of purified gluten and whole wheat (gluten combined with amylase-trypsin inhibitors (ATIs)) on inducing intestinal and extra-intestinal symptoms in irritable bowel syndrome (IBS) patients. All participants will be put on a gluten-free diet and then challenged with muesli bars containing either purified gluten, whole wheat (gluten with ATIs), or gluten-free sham.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Irritable bowel syndrome (IBS) is a heterogenous, common gastrointestinal disorder characterized by chronic abdominal pain and altered bowel habits. Many IBS patients report symptom relief on a gluten-free diet (GFD), but it is uncertain whether gluten is the true culprit. The gluten-containing grains wheat, rye, and barley all contain amylase-trypsin inhibitors (ATIs), and a GFD is virtually ATI-free.

This double-blinded crossover randomized controlled trial aims to determine which IBS patients are affected by pure gluten and which are affected by gluten combined with ATIs. IBS patients who respond to and have been on a GFD for 3+ weeks will be randomized to receive a dietary challenge of muesli bars containing either 1) 10 g pure gluten, 2) whole wheat (containing 10 g gluten and wheat ATIs), 3) or gluten-free sham for a week followed by a 14 day washout. This will be repeated until all participants have had each dietary challenge.

The study will evaluate the effects and potential mechanisms of purified gluten and whole wheat (containing the same dose of non-purified gluten) on intestinal and extra-intestinal symptoms in IBS. It is likely that some IBS patients respond to gluten, while others respond to whole wheat containing gluten combined with wheat ATIs. Thus, this project may lead to better diagnosis and individualized dietary treatments for IBS.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
29

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8N 3Z5
        • McMaster University Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • IBS diagnosis based on Rome IV criteria.
  • Previously improved while on a gluten-free diet.
  • Compliance with the study procedures (according to the investigator's own judgement).
  • Signing the Study Informed Consent form.

Exclusion Criteria:

  • Concurrent systemic disease and/or laboratory abnormalities considered by investigators to be risky or that could interfere with data collection.
  • Concurrent organic gastrointestinal disease (i.e. Celiac disease, Inflammatory Bowel Disease, peptic ulcer disease, etc.) other than benign polyps, diverticulosis, hemorrhoids, lipoma and melanosis coli.
  • Major abdominal surgery with the exception of hernia repair, appendectomy, Caesarian section, tubal ligation, cholecystectomy, hysterectomy, and hemorrhoidectomy.
  • History of active cancer in the last 5 years, other than skin basal cells cancer.
  • Pregnant or breastfeeding women.
  • Current use of antibiotics or antibiotic treatment within 1 months before the first visit.
  • Consumption of probiotics within 1 month prior to the first visit.
  • Use of non-authorized medications (see Unauthorized Medications section).
  • Patients on a high fibre diet (>35 g/day for males, > 25 g/day for females), consuming high inulin containing foods (>5 g/day), and/or consuming dietary fibre supplements (as assessed by dietary assessment questionnaire) in the 4 weeks prior to the first visit.
  • Patients currently participating or having participated in a trial within the past month.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Purified Gluten (10 g), Whole Wheat (containing 10 g Gluten and Wheat ATIs), Gluten-free Sham
Participants will start on 1 week of muesli bars with 10 g purified gluten followed by 14 days washout. They will then take 1 week of muesli bars with whole wheat (containing 10 g non-purified gluten and wheat ATIs) followed by 14 days of washout. Finally, they will have 1 week of gluten-free sham muesli bars (with nothing).
Other: Purified gluten
1 low FODMAPs, vegan muesli bar containing purified gluten per day for 1 week, for a total of 10 g purified gluten per day.
Other: Non-purified gluten (containing ATIs)
1 low FODMAPs, vegan muesli bar containing whole wheat flour with non-purified gluten per day for 1 week, for a total of 10 g non-purified gluten per day.
Other: Sham
1 gluten-free, ATI-free, low FODMAPs, vegan muesli bar per day for 1 week. This is a sham because participants were blinded to the identity of this gluten-free control and randomly assigned to it.
Experimental: Purified Gluten (10 g), Gluten-free Sham, Whole Wheat (containing 10 g Gluten and Wheat ATIs)
Participants will start on 1 week of muesli bars with 10 g purified gluten followed by 14 days washout. They will then take 1 week of gluten-free sham muesli bars (with nothing) followed by 14 days of washout. Finally, they will have 1 week of muesli bars with whole wheat (containing 10 g non-purified gluten and wheat ATIs).
Other: Purified gluten
1 low FODMAPs, vegan muesli bar containing purified gluten per day for 1 week, for a total of 10 g purified gluten per day.
Other: Non-purified gluten (containing ATIs)
1 low FODMAPs, vegan muesli bar containing whole wheat flour with non-purified gluten per day for 1 week, for a total of 10 g non-purified gluten per day.
Other: Sham
1 gluten-free, ATI-free, low FODMAPs, vegan muesli bar per day for 1 week. This is a sham because participants were blinded to the identity of this gluten-free control and randomly assigned to it.
Experimental: Whole Wheat (containing 10 g Gluten and Wheat ATIs), Purified Gluten (10 g), Gluten-free Sham
Participants will start on 1 week of muesli bars with whole wheat (containing 10 g non-purified gluten and wheat ATIs) followed by 14 days washout. They will then take 1 week of muesli bars with 10 g purified gluten followed by 14 days of washout. Finally, they will have 1 week of gluten-free sham muesli bars (with nothing).
Other: Purified gluten
1 low FODMAPs, vegan muesli bar containing purified gluten per day for 1 week, for a total of 10 g purified gluten per day.
Other: Non-purified gluten (containing ATIs)
1 low FODMAPs, vegan muesli bar containing whole wheat flour with non-purified gluten per day for 1 week, for a total of 10 g non-purified gluten per day.
Other: Sham
1 gluten-free, ATI-free, low FODMAPs, vegan muesli bar per day for 1 week. This is a sham because participants were blinded to the identity of this gluten-free control and randomly assigned to it.
Experimental: Whole Wheat (containing 10 g Gluten and Wheat ATIs), Gluten-free Sham, Purified Gluten (10 g)
Participants will start on 1 week of muesli bars with whole wheat (containing 10 g non-purified gluten and wheat ATIs) followed by 14 days washout. They will then take 1 week of gluten-free sham muesli bars (containing nothing) followed by 14 days of washout. Finally, they will have 1 week of muesli bars with 10 g purified gluten.
Other: Purified gluten
1 low FODMAPs, vegan muesli bar containing purified gluten per day for 1 week, for a total of 10 g purified gluten per day.
Other: Non-purified gluten (containing ATIs)
1 low FODMAPs, vegan muesli bar containing whole wheat flour with non-purified gluten per day for 1 week, for a total of 10 g non-purified gluten per day.
Other: Sham
1 gluten-free, ATI-free, low FODMAPs, vegan muesli bar per day for 1 week. This is a sham because participants were blinded to the identity of this gluten-free control and randomly assigned to it.
Experimental: Gluten-free Sham, Whole Wheat (containing 10 g Gluten and Wheat ATIs), Purified Gluten (10 g)
Participants will start on 1 week of gluten-free sham muesli bars (with nothing) followed by 14 days washout. They will then take 1 week of muesli bars containing whole wheat (containing 10 g non-purified gluten and wheat ATIs) followed by 14 days of washout. Finally, they will have 1 week of muesli bars with 10 g purified gluten.
Other: Purified gluten
1 low FODMAPs, vegan muesli bar containing purified gluten per day for 1 week, for a total of 10 g purified gluten per day.
Other: Non-purified gluten (containing ATIs)
1 low FODMAPs, vegan muesli bar containing whole wheat flour with non-purified gluten per day for 1 week, for a total of 10 g non-purified gluten per day.
Other: Sham
1 gluten-free, ATI-free, low FODMAPs, vegan muesli bar per day for 1 week. This is a sham because participants were blinded to the identity of this gluten-free control and randomly assigned to it.
Experimental: Gluten-free Sham, Purified Gluten (10 g), Whole Wheat (containing 10 g Gluten and Wheat ATIs)
Participants will start on 1 week of gluten-free sham muesli bars (with nothing) followed by 14 days washout. They will then take 1 week of muesli bars with 10 g purified gluten followed by 14 days of washout. Finally, they will have 1 week of muesli bars with whole wheat (containing 10 g non-purified gluten and wheat ATIs).
Other: Purified gluten
1 low FODMAPs, vegan muesli bar containing purified gluten per day for 1 week, for a total of 10 g purified gluten per day.
Other: Non-purified gluten (containing ATIs)
1 low FODMAPs, vegan muesli bar containing whole wheat flour with non-purified gluten per day for 1 week, for a total of 10 g non-purified gluten per day.
Other: Sham
1 gluten-free, ATI-free, low FODMAPs, vegan muesli bar per day for 1 week. This is a sham because participants were blinded to the identity of this gluten-free control and randomly assigned to it.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Worsening Irritable Bowel Syndrome (IBS) Symptoms Based on IBS-SSS
Time Frame: 1 week purified gluten or whole wheat (gluten+ATIs) intervention versus gluten-free sham. Outcomes were measured at baseline for Pre-Sham, Pre-Gluten and Pre-Wheat Arm/Groups and 1 week for Sham, Gluten and Wheat Arm/Groups.
Number of participants with a clinically meaningful worsening of symptoms during dietary challenge compared to sham, as defined by an increase of >50 points in the Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS). The IBS-SSS ranges from 0 to 500, with higher scores indicating greater symptom severity. A >50-point increase is considered a clinically significant worsening.
1 week purified gluten or whole wheat (gluten+ATIs) intervention versus gluten-free sham. Outcomes were measured at baseline for Pre-Sham, Pre-Gluten and Pre-Wheat Arm/Groups and 1 week for Sham, Gluten and Wheat Arm/Groups.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
General Gastrointestinal Symptoms
Time Frame: 1 week purified gluten or whole wheat (gluten+ATIs) intervention compared to gluten-free sham. Outcomes were measured at 1 week for Sham, Gluten and Wheat Arm/Groups.
Worsening of general gastrointestinal symptoms (using The Patient-Reported Outcomes Measurement Information System (PROMIS Scales) for belly pain, diarrhea, constipation, or gas & bloating) after dietary challenge compared to sham. Scores are calculated using the Scoring Service by Health Measures and range from 20-80, with medians set at 50 and a standard deviation of 10. Higher scores indicate greater symptom severity. Four PROMIS subscales are being used: Gas & Bloating, Diarrhea, Constipation, and Belly Pain. Each subscale follows the T-scale scoring range of 20-80 and will be measured independently.
1 week purified gluten or whole wheat (gluten+ATIs) intervention compared to gluten-free sham. Outcomes were measured at 1 week for Sham, Gluten and Wheat Arm/Groups.
Orocecal Transit
Time Frame: Assessed at 1 week after each intervention period (Sham, Gluten, and Wheat).

Colonic transit assessed by SHAPE study (radiopaque markers).

We measured orocecal transit time according to a modified SHAPE study using radiopaque markers, clinically used to identify patients with colonic inertia. Participants consumed 1 SITZARKS capsule (Konsyl Pharmaceuticals, Easton, MD) containing 24 markers, 48 hours prior to a plain abdominal film. A technician took a plain abdominal x-ray to provide images of the number and locations of the markers remaining in the gastrointestinal tract at 48 hours. A greater number of markers (up to 24) indicates slower gastrointestinal transit while less markers (or none) indicate faster transit.

The outcome was assessed at the end of each 1-week intervention period (i.e., at Week 1 for Sham, Gluten, and Wheat Arms). Due to the COVID-19 pandemic, in-person study visits were limited and the SHAPE study was only conducted in N=13 participants.
Assessed at 1 week after each intervention period (Sham, Gluten, and Wheat).
Anti-gliadin Antibody (AGA) Levels
Time Frame: Serum AGAs were measured at baseline.

Change in AGA levels after purified gluten and whole wheat (gluten+wheat ATI) challenge will be assessed by ELISA

NOTE: Due to the COVID-19 pandemic, in-person, non-essential blood withdrawals were paused. Blood collection occurred pre-pandemic and after in-person visits were allowed, in a total of N=14 participants. A post-study follow-up amendment, accepted by the Hamilton integrated Research Ethics Board (HiREB), allowed post-study collection of blood samples to assess the presence of AGAs and genetic markers.
Serum AGAs were measured at baseline.
Gut Microbiota Profiles
Time Frame: Stool samples collected at 1 week after each intervention period (Sham, Gluten, and Wheat)
This outcome was intended to assess gut microbiota profiles using 16S rRNA Illumina sequencing of stool samples collected after each 1-week intervention period. However, data for this outcome are not available.
Stool samples collected at 1 week after each intervention period (Sham, Gluten, and Wheat)
Genetic Predisposition for Celiac Disease
Time Frame: Patient HLA DQ2/8 status were measured at baseline

Patient HLADQ2/8 status will be assessed at baseline

NOTE: Due to the COVID-19 pandemic, in-person, non-essential blood withdrawals were paused. Blood collection occurred pre-pandemic and after in-person visits were allowed, in a total of N=14 participants. A post-study follow-up, accepted by the Hamilton integrated Research Ethics Board (HiREB), allowed post-study collection of blood samples to assess the presence of AGAs and genetic markers.
Patient HLA DQ2/8 status were measured at baseline
Depression, Anxiety and Stress
Time Frame: 1 week purified gluten or whole wheat (gluten+ATIs) intervention compared to gluten-free sham. Outcomes were measured at 1 week for Sham, Gluten and Wheat Arm/Groups.
Worsening of depression, anxiety, and stress sub-scales during dietary challenge was assessed by Depression Anxiety Stress Scale (DASS-21). The DASS-21 has 21 questions. The three subscales (depression, anxiety, and stress) are reported independently and range from 0 to 42, with higher scores indicating greater symptom severity.
1 week purified gluten or whole wheat (gluten+ATIs) intervention compared to gluten-free sham. Outcomes were measured at 1 week for Sham, Gluten and Wheat Arm/Groups.
Somatic Symptoms
Time Frame: 1 week purified gluten or whole wheat (gluten+ATIs) intervention compared to gluten-free sham. Outcomes were measured at 1 week for Sham, Gluten and Wheat Arm/Groups.
Worsening of somatic symptoms like fatigue, sleeping trouble, and pain were assessed using Patient Health Questionnaire (PHQ-15). Scores range from 0 to 30, with greater scores indicating greater severity.
1 week purified gluten or whole wheat (gluten+ATIs) intervention compared to gluten-free sham. Outcomes were measured at 1 week for Sham, Gluten and Wheat Arm/Groups.
Stool Consistency
Time Frame: 1 week purified gluten or whole wheat (gluten+ATIs) intervention compared to gluten-free sham. Outcomes were measured at 1 week for Sham, Gluten and Wheat Arm/Groups.
Stool consistency was assessed by Bristol Stool Scale. Types 1 and 2 indicate harder stools, types 3, 4, and 5 are normal, and types 6 and 7 indicate runnier, more liquid stool.
1 week purified gluten or whole wheat (gluten+ATIs) intervention compared to gluten-free sham. Outcomes were measured at 1 week for Sham, Gluten and Wheat Arm/Groups.
Gluten Levels in Stool
Time Frame: Assessed at 1 week after each intervention period (Sham, Gluten, and Wheat).

Presence of gluten in stool samples was assessed to evaluate dietary compliance using an ELISA for gluten immunogenic peptides (GIP), measured in micrograms per gram of stool (μg/g).

Stool samples were collected at the end of each 1-week intervention period (i.e., at Week 1 for Sham, Gluten, and Wheat). The values reported reflect GIP concentration at the end of each intervention.
Assessed at 1 week after each intervention period (Sham, Gluten, and Wheat).
Diet Assessment
Time Frame: During each 1-week intervention period (Sham, Gluten, and Wheat).
This outcome was intended to assess dietary intake and compliance during each 1-week intervention period using the MealLogger app. Participants were instructed to take pictures of all meals during each intervention week to support dietary tracking and adherence monitoring. However, image analysis was not performed and data for this outcome are not available.
During each 1-week intervention period (Sham, Gluten, and Wheat).
IBS Symptom Duration
Time Frame: Completed daily for 7 days after each diet challenge
Evaluates symptom duration at the end of the diet challenge using the IBS-SSS. The overall score ranges from 0-500 in total, with each of the 5 questions ranging from 0 to 100. A higher score indicates higher symptom severity and the total score is summed.
Completed daily for 7 days after each diet challenge
Systemic Immune Reactivity
Time Frame: Blood collected at baseline and post-intervention for each 1-week dietary period (Sham, Gluten, and Wheat).
This outcome was intended to assess changes in pro-inflammatory cytokines (TNF-α, IL-8, and IFN-γ) using ex vivo peripheral blood mononuclear cell (PBMC) stimulation in a subset of participants. Blood was collected at baseline and after each 1-week dietary intervention (Sham, Gluten, and Wheat) to isolate PBMCs. However, due to the COVID-19 pandemic and the limited clinical phenotype observed, PBMC samples (N=11) were not analyzed. No outcome data are available.
Blood collected at baseline and post-intervention for each 1-week dietary period (Sham, Gluten, and Wheat).
Long-term Gluten-free Diet Adherence
Time Frame: At least 6-months (up to 41 months) after primary study completion, followed by 1+ months after study result disclosure.

At study completion and unblinding, the researchers compiled the study results (ex., worsening in IBS symptoms after gluten challenge) and provided this information to study participants after their study completion. An expert interview-based gluten-free diet assessment used previously in the study was conducted with study participants immediately prior and one month after.

This amendment was approved by the Hamilton Ethics Board in June 2022 and was based on participant requests. We used the same gluten-free diet assessment as the primary study. We included new pre- and post-disclosure surveys to ask about current diet habits, beliefs surrounding wheat/gluten sensitivity, and how their behaviours would change after results disclosure.
At least 6-months (up to 41 months) after primary study completion, followed by 1+ months after study result disclosure.
Psychological and Gastrointestinal Symptoms After Learning Diet Triggers and Genetic Results (Unblinding Participants to Diet Triggers During Post-study Follow-up)
Time Frame: At least 6-months (up to 41 months) after primary study completion, followed by 1+ months after study result disclosure.

At study completion and unblinding, the team compiled the study results (ex., worsening in IBS symptoms after challenges) and provided this information to participants. Previous study surveys were sent to participants immediately prior and 1 month after.

We used the following outcomes:

  • IBS symptoms: IBS Symptom Severity Score (IBS-SSS, range=[0, 500], higher score=worse symptoms)
  • General gastrointestinal symptoms: Patient-Reported Outcomes Measurement Information System (PROMIS) sub-scales for abdominal pain, diarrhea, constipation, bloating & gas (each sub-scale has a range of 20-80 and higher scores=worse symptoms)
  • Mood: Depression, Anxiety & Stress Scale (DASS21, each sub-score [depression/anxiety/stress] has a range of 0-42 and higher scores=worse symptoms)
  • Somatic symptoms: Patient Health Questionnaire 15 (PHQ15), range=(0, 30), greater score=worse symptoms)

For greater detail, see above secondary outcome measure descriptions.
At least 6-months (up to 41 months) after primary study completion, followed by 1+ months after study result disclosure.
Irritable Bowel Syndrome (IBS) Symptoms (Continuous)
Time Frame: 1 week purified gluten or whole wheat (gluten+ATIs) intervention versus gluten-free sham. Outcomes were measured at 1 week for Sham, Gluten and Wheat Arm/Groups.
Worsening of IBS symptoms (using Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS)) during dietary challenge compared to sham. The overall score ranges from 0-500 in total, with each of the 5 questions ranging from 0 to 100. A higher score indicates higher symptom severity and the total score is summed. An increase in >50 points indicates worsening of symptoms.
1 week purified gluten or whole wheat (gluten+ATIs) intervention versus gluten-free sham. Outcomes were measured at 1 week for Sham, Gluten and Wheat Arm/Groups.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
McMaster University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Maria Ines Pinto-Sanchez, MD, McMaster University
  • Principal Investigator: Premysl Bercik, MD, McMaster University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 20, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 22, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 7, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 10, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Diet in IBS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Irritable Bowel Syndrome

Clinical Trials on Purified gluten

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings