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

NCT02450370 | Completed DMC

• 1 other identifier: REC-201405
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

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.

Conditions

Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

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

  10 weeks

Study Arms (2)

Conventional IBS diet group

ACTIVE COMPARATOR

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

Low FODMAP diet group

EXPERIMENTAL

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

Interventions

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.

Low FODMAP diet group

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.

Conventional IBS diet group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hong Kong Sanatorium & Hospital: lead
• The Hong Kong Society of Gastrointestinal Motility: collaborator

Study Sites (1)

Dietetic Service, HKSH

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

FODMAP Diet

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Elimination Diets; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Jessica Chow, MSc

  Hong Kong Sanatorium & Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2015
• First Posted: May 21, 2015
• Study Start: May 1, 2015
• Primary Completion: November 20, 2017
• Study Completion: November 20, 2017
• Last Updated: June 25, 2018

Record last verified: 2018-06

Locations

HK (1)