Irritable bowel syndrome
Conditions
Interventions
Low FODMAP food
Dietary Counseling Based on the Clinical Practice Guidelines for Functional Gastrointestinal Disorders
Sponsors
Shiga University of Medical Science
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Diagnosis: Irritable bowel syndrome (IBS) diagnosed according to the Rome III or Rome IV criteria Disease severity: An IBS Symptom Severity Score (IBS-SSS) of >=175 Sex: Both males and females Age: >=18 and <=100 years at the time of enrollment
Exclusion criteria
Exclusion criteria: Patients who had followed a low-FODMAP diet within 3 months prior to obtaining informed consent (self-reported) Use of antibiotics within 3 months prior to obtaining informed consent Pregnancy History of colectomy Presence of severe diabetes mellitus Presence of organic disease considered to affect gastrointestinal symptoms
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy rate after 4 weeks (cases with IBS-SSS reduced by 50 points or more are considered valid) | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage reduction in the IBS Symptom Severity Score (IBS-SSS) at 4 weeks compared with baseline Improvement rate in IBS-SSS stratified by IBS subtype Improvement rates in IBS-Quality of Life (IBS-QOL), Visceral Sensitivity Index (VSI), and Gastrointestinal Symptom Rating Scale (GSRS) Improvement rate in the Bristol Stool Form Scale (BSFS) Analysis of changes in the gut microbiota induced by a low-FODMAP diet Change in the positivity rate of the hydrogen breath test Association between baseline hydrogen breath test results and the efficacy of a low-FODMAP diet | — |
Countries
Japan
Contacts
Public ContactShigeki Bamba
Shiga University of Medical Science Department of Fundamental Nursing
Outcome results
None listed