RCT: Effect of Late vs Early Introduction of Gluten-free Oats on Patients With Newly Diagnosed Celiac Disease.

March 12, 2024 updated by: Maria Ines Pinto Sanchez, McMaster University

A Randomized Controlled Trial to Evaluate Effect of Late vs Early Introduction of Gluten-free Oats on Symptomatic, Serologic and Disease Activity in Patients With Newly Diagnosed Celiac Disease.

The investigators are conducting a pilot study to investigate the impact of late compared to early introduction of gluten-free oats on gut symptoms, nutrition status, celiac activity and quality of life in patients with a recent diagnosis of celiac disease. Pilot study means that it will recruit a low number of participants to see if it is possible to perform the study, and to estimate how many participants will be needed for the large study. The study will collect information through questionnaires that assess gut symptoms, quality of life, mood changes and dietary patterns. Moreover, the study will collect data on tests done during clinic visits to check the status of patients' celiac markers and nutritional status (such as vitamins and minerals). Physical exam will also take place, and include measurement of weight, BMI and body composition in a 3D scanner. The dietitian will analyze patients' diet at each visit during the study period. Given the lack of evidence on timing of introduction of gluten-free oats for patients with a recent celiac diagnosis, and the potential risks of limiting oats in a gluten-free diet, the results will hopefully lead to better understanding of whether one strategy has a benefit over the other.

Study Overview

Status

Status

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

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

Celiac disease (CeD) is a chronic inflammatory condition triggered by gluten in genetically predisposed individuals, manifesting with both intestinal and extra-intestinal symptoms. There is a relatively high prevalence of CeD in Western populations of around 1%. People with CeD have adverse immune-mediated reactions to gluten, which is the most abundant protein in many cereal grains, including wheat, rye, and barley. Currently, the only available treatment for CeD is a gluten-free diet (GFD). Gluten-free products are defined as containing less than 20 ppm of gluten, an international standard set by Codex Alimentarius Commission based on scientific data.

Oats are safe for most people with CeD, provided they are pure and uncontaminated with gluten. A small proportion of patients will react to avenin, the protein contained in oats, but this does not lead to intestinal inflammation. However, oats, including some brands labelled as gluten-free, are often contaminated with gluten, most notably from cross-contamination with wheat and barley due to agricultural practices. Furthermore, many patients remain symptomatic despite adhering to a GFD for different reasons, and concerns have been raised over whether continue eating oats to a GFD may contribute to persisting symptoms. For this reason, some experts in CeD recommend to delay the introduction of oats until 6 months after the diagnosis as part of a stabilization phase, after which the CeD is under better control and TTG autoantibody levels have decreased. However, there is no evidence this approach has any benefit over permitting the intake of GF oats from the time of diagnosis.

A GFD is restrictive and has been associated with nutritional deficiencies. Oats are highly nutritious and possess additional health benefits. They are an excellent source of macro- and micro-nutrients, including B complex vitamins, minerals, and heart-healthy soluble dietary fiber. These nutrients are essential in prevention of many chronic diseases such as diabetes and reducing cardiovascular risk factors. In addition, preliminary research suggests a benefit of oats on the gut microbiome.

Considering how rarely CeD patients react to oats and the numerous benefits of oats for nutrition and overall health, the delayed introduction of oats into the GFD, provided they are certified GF, has come under scrutiny. Given the lack of evidence that a delayed introduction of oats is beneficial for CeD patients and the potential risks of limiting oats in a GFD, there is an unmet need to understand the benefits of one approach over the other to provide recommendations for clinical practice.

This study proposes a pilot randomized controlled trial (RCT) to investigate the impact of late compared to early introduction of oats on gastrointestinal symptoms, nutritional status, disease activity and quality of life in patients with a recent diagnosis of CeD. The results of this study will provide the basis to plan an adequately powered RCT, and the results of the study will be highly relevant to guide recommendations in clinical practice on when oats should be introduced to patients with a CeD diagnosis.

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 (Estimated)

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.
50

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 Contact Backup

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8S2H1
        • Recruiting
        • McMaster University Medical Center
        • Contact:
          • Nicole Chang, MD

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Recent diagnosis of CeD (within 3 months of starting a GFD) based on specific CeD serology (elevated anti-tissue transglutaminase IgA, deaminated gliadin peptides IgG or anti-endomysial antibodies IgA) and confirmed by duodenal biopsies showing villous atrophy (Marsh 3a or greater). The allowance of 3 months is related to 1) the time lag between tTG and confirmatory EGD testing in clinical practice and 2) the time lag between diagnosis and dietitian assessment, which will increase likelihood of achieving a strict GFD.

Exclusion Criteria:

  1. Have already removed oats from the diet;
  2. History of allergic reaction to oats
  3. Prior assessment and education by RD on GFD
  4. Unwillingness or inability to commit to study procedures *Patients receiving antibiotics or probiotics within a month will be allowed to participate, however, this will be documented for future microbiota analysis.

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: Parallel Assignment
  • Masking: Single

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: Early introduction of gluten free oats
Early introduction of oats (starting GF oats immediately after the diagnosis, within 3 months)
Other: gluten-free oats
Early vs late introduction of gluten free oats
Active Comparator: Late introduction of gluten free oats
Late introduction of oats (starting GF oats 6 months after diagnosis of celiac disease)
Other: gluten-free oats
Early vs late introduction of gluten free oats

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
Better symptom control
Time Frame: 3-6 months
To assess the impact of late (after 6 months) vs early (immediate) introduction of gluten-free oats as part of a gluten-free diet on achieving better symptom control (change in Celiac Disease Gastrointestinal Symptom Rating Scale scores; range 15-115; lower the score, the better the outcome) at 3- and 6-month follow-up
3-6 months
tTG antibody levels
Time Frame: 6 months

To assess the impact of late (after 6 months) vs early (immediate) introduction of gluten-free oats as part of a gluten-free diet on achieving:

Change in tTG antibody levels at 6-month follow-up
6 months
improvement of nutritional status
Time Frame: 6 months

To assess the impact of late (after 6 months) vs early (immediate) introduction of gluten-free oats as part of a gluten-free diet on achieving:

improvement of nutritional status (reduce % body fat mass)
6 months
improvement in quality of life (change in Celiac Disease Quality of Life scores)
Time Frame: 3-6 months

To assess the impact of late (after 6 months) vs early (immediate) introduction of gluten-free oats as part of a gluten-free diet on achieving:

improvement in quality of life (change in Celiac Disease Quality of Life scores, 20-100, lower the score better the outcome) at 3- and 6-month follow-up
3-6 months
Food insecurity
Time Frame: 6 months
Food insecurity will be assessed through Household Food Security Survey Module (HFSSM)
6 months

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: Jedid-Jah Blom, RD, Hamilton Health Sciences Corporation

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.
June 1, 2023

Primary Completion (Estimated)

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.
December 1, 2024

Study Completion (Estimated)

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.
May 1, 2025

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).
January 24, 2023

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.
March 27, 2023

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.
April 7, 2023

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.
March 15, 2024

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, 2024

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, 2024

More Information

Terms related to this study

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.
  • 15964

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.

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