UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060535 |
|---|---|
| Receipt number | R000069226 |
| Scientific Title | The usefulness of low FODMAP diet for irritable bowel syndrome |
| Date of disclosure of the study information | 2026/01/31 |
| Last modified on | 2026/01/31 12:36:29 |
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Basic information
Public title
The usefulness of low FODMAP diet for irritable bowel syndrome
Acronym
Low FODMAP diet and IBS
Scientific Title
The usefulness of low FODMAP diet for irritable bowel syndrome
Scientific Title:Acronym
Low FODMAP diet and IBS
Region
| Japan |
Condition
Condition
Irritable bowel syndrome
Classification by specialty
| Medicine in general | Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the usefulness of a low FODMAP diet for IBS and to investigate the impact of a low FODMAP diet on the intestinal microbiota.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Efficacy rate after 4 weeks (cases with IBS-SSS reduced by 50 points or more are considered valid)
Key secondary outcomes
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
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Low FODMAP food
Interventions/Control_2
Dietary Counseling Based on the Clinical Practice Guidelines for Functional Gastrointestinal Disorders
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key 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
Key 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
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | Shigeki |
| Middle name | |
| Last name | Bamba |
Organization
Shiga University of Medical Science
Division name
Department of Fundamental Nursing
Zip code
520-2192
Address
Seta-Tsukinowa, Otsu
TEL
077-548-2544
sb@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | Shigeki |
| Middle name | |
| Last name | Bamba |
Organization
Shiga University of Medical Science
Division name
Department of Fundamental Nursing
Zip code
520-2192
Address
Seta-Tsukinowa, Otsu
TEL
077-548-2544
Homepage URL
sb@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Shiga University of Medical Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shiga University of Medical Science
Address
Seta-Tsukinowa. Otsu
Tel
077548-2544
sb@belle.shiga-med.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2026 | Year | 01 | Month | 29 | Day |
Date of IRB
| 2026 | Year | 01 | Month | 29 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 29 | Day |
Last follow-up date
| 2030 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 01 | Month | 31 | Day |
Last modified on
| 2026 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069226
