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

Primary Purpose

Irritable Bowel Syndrome

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Low FODMAP diet
Conventional IBS diet group
Sponsored by
Hong Kong Sanatorium & Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dietetic Service, HKSH

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional IBS diet group

Low FODMAP diet group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Improvement in IBS symptoms after adopting the low FOMDAP diet versus conventional IBS diet using IBS Global Improvement Scale

Secondary Outcome Measures

Full Information

First Posted
May 19, 2015
Last Updated
June 20, 2018
Sponsor
Hong Kong Sanatorium & Hospital
Collaborators
The Hong Kong Society of Gastrointestinal Motility
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1. Study Identification

Unique Protocol Identification Number
NCT02450370
Brief Title
Diets in Symptom Relief and the Influence of Quality of Life in People With Irritable Bowel Syndrome
Official Title
Comparison of Symptom Response Following a Conventional Irritable Bowel Syndrome Dietary Advice Versus Low FODMAP Diet in Hong Kong Chinese Irritable Bowel Syndrome Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
November 20, 2017 (Actual)
Study Completion Date
November 20, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hong Kong Sanatorium & Hospital
Collaborators
The Hong Kong Society of Gastrointestinal Motility

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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 Subjects will be blinded and randomly assigned to Conventional IBS diet group (A) or Low FODMAP diet group (B) 3 Breath tests (lactulose, fructose, lactose) will be carried out for all subjects before diet education 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 Subjects will be asked to record their food intake and signs and symptoms onto a food record book Subjects will be asked to fill out the IBS Global Improvement Scale and the IBSQOL questionnaire at Week 0, 6 & 10 At week 4 and week 8, telephone interviews will be conducted by the dietitians to reinforce diets and answer diet questions 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 Chi square test will be used to look at the association between breath tests results and responds to the two diets

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
103 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional IBS diet group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Low FODMAP diet group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Low FODMAP diet
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Conventional IBS diet group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Improvement in IBS symptoms after adopting the low FOMDAP diet versus conventional IBS diet using IBS Global Improvement Scale
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica Chow, MSc
Organizational Affiliation
Hong Kong Sanatorium & Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dietetic Service, HKSH
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

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

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