Skip to main content
OpenTrials
Completed

NCT Number: NCT02450370

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dietetic Service, HKSH

Hong Kong

About this study

  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low FODMAP diet

Behavioral

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.

Conventional IBS diet group

Behavioral

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 outcomes

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

    Time frame: 10 weeks

Sponsors and collaborators

Lead sponsor

Hong Kong Sanatorium & Hospital

Industry

Collaborators

  • The Hong Kong Society of Gastrointestinal Motility

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
May 21, 2015
Registry last updated
Jun 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.