Tokyo, Feb. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060535) titled 'The usefulness of low FODMAP diet for irritable bowel syndrome' on Jan. 31.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -no one is blinded
Control - Active
Primary Sponsor:
Institute - Shiga University of Medical Science
Condition:
Condition - Irritable bowel syndrome
Classification by malignancy - Others
Genomic information - NO
Objective:
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
Intervention:
Interventions/Control_1 - Low FODMAP food
Interventions/Control_2 - Dietary Counseling Based on the Clinical Practice Guidelines for Functional Gastrointestinal Disorders
Eligibility:
Age-lower limit - 18
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 Size - 130
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069226
Disclaimer: Curated by HT Syndication.
