Diets in Symptom Relief and the Influence of Quality of Life in People With Irritable Bowel Syndrome

June 20, 2018 updated by: Hong Kong Sanatorium & Hospital

Comparison of Symptom Response Following a Conventional Irritable Bowel Syndrome Dietary Advice Versus Low FODMAP Diet in Hong Kong Chinese Irritable Bowel Syndrome Patients

Subjects with confirmed diagnosis of Irritable Bowel Syndrome will be blinded and randomly assigned to one of two groups, the low FODMAP diet or the conventional IBS diet group. They will be referred to do three hydrogen breath tests prior to diet education. Upon completion, subjects will attend dietitian consultations at Week 0, 6 and 10 for diet assessment, education and reinforcement. At Week 4 and 8, dietitians will telephone patients to check on diet compliance and answer any diet question. Two sets of questionnaires, the IBS Global Improvement Scale and the IBSQOL will be given to patients to complete before each dietitian visit at week 0, 6 and 10. Two sample t-test and Chi square test will be used to test the difference between the two groups and the association between breath tests results and responds to the two diets.

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

  1. Subjects who are interested will be interviewed and screened for IBS with Rome Ⅲ criteria by the principle investigator. Research information will be explained in length and consent form will be signed if they agreed to participate
  2. Subjects will be blinded and randomly assigned to Conventional IBS diet group (A) or Low FODMAP diet group (B)
  3. 3 Breath tests (lactulose, fructose, lactose) will be carried out for all subjects before diet education
  4. Subjects will be asked to come to the dietitians clinic and receive the first one hour diet education (including diet assessment & diet education) and two times thirty minutes follow-up appointments with the dietitians at Week 0, 6 and 10, respectively
  5. Subjects will be asked to record their food intake and signs and symptoms onto a food record book
  6. Subjects will be asked to fill out the IBS Global Improvement Scale and the IBSQOL questionnaire at Week 0, 6 & 10
  7. At week 4 and week 8, telephone interviews will be conducted by the dietitians to reinforce diets and answer diet questions
  8. Results of IBS Global Improvement Scale and IBSQOL questionnaire will be analyzed using two sample t-test to test the difference between control and treatment group
  9. Chi square test will be used to look at the association between breath tests results and responds to the two diets

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.
103

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 Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Dietetic Service, HKSH

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

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults >18 years
  • Confirmed IBS (after meeting Rome Ⅲ criteria)
  • Hong Kong Chinese

Exclusion Criteria:

  • Age <18 years
  • Pregnancy
  • Other ethnicities besides Hong Kong Chinese
  • Significant GI co-morbidities such as Inflammatory Bowel Disease, Coeliac disease, significant diverticular disease, history of GI cancer, GI resection and GI reconstruction

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

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.
Active Comparator: Conventional IBS diet group
Subjects in this group will follow a conventional diet for up to 10 weeks. They will receive 3 dietetic consultations at week 0,6 and 10. This diet will focus on small frequent meals, no skipping meals and dietary adjustments for bloatedness, diarrhea and constipation. Advice on intake of caffeine and alcohol will also be given. Dietary leaflets will be provided.
Behavioral: Conventional IBS diet group
Subjects in this group will follow a conventional diet for up to 10 weeks. They will receive 3 dietetic consultations at week 0,6 and 10. This diet will focus on small frequent meals, no skipping meals and dietary adjustments for bloatedness, diarrhea and constipation. Advice on intake of caffeine and alcohol will also be given. Dietary leaflets will be provided.
Experimental: Low FODMAP diet group
Subjects in this group will follow a low FODMAP diet for up to 10 weeks. Foods that are high in oligosaccharides, disaccharides, monosaccharides and polyols will be avoided. They will receive 3 dietetic consultations at week 0,6 and 10. Dietary leaflets, including meal samples and Yes/No food lists will be provided.
Behavioral: Low FODMAP diet
Subjects in this group will follow a low FODMAP diet for up to 10 weeks. Foods that are high in oligosaccharides, disaccharides, monosaccharides and polyols will be avoided. They will receive 3 dietetic consultations at week 0,6 and 10. Dietary leaflets, including meal samples and Yes/No food lists will be provided.

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
Time Frame
Improvement in IBS symptoms after adopting the low FOMDAP diet versus conventional IBS diet using IBS Global Improvement Scale
Time Frame: 10 weeks
10 weeks

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.
Hong Kong Sanatorium & Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Hong Kong Society of Gastrointestinal Motility

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.
  • Principal Investigator: Jessica Chow, MSc, Hong Kong Sanatorium & Hospital

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

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.
May 1, 2015

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.
November 20, 2017

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.
November 20, 2017

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).
May 19, 2015

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.
May 19, 2015

First Posted (Estimate)

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.
May 21, 2015

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.
June 25, 2018

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.
June 20, 2018

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.
June 1, 2018

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.
  • REC-201405

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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