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Evaluation of Treatment Effect of Low FODMAP Diet in Treatment of IBS Patients

Evaluation of Treatment Effect and Mechanism of Low FODMAP Diet in Treatment of Irritable Bowel Syndrome Patients

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05144204
Enrollment
30
Registered
2021-12-03
Start date
2021-12-01
Completion date
2023-12-31
Last updated
2021-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irritable Bowel Syndrome

Keywords

Low FODMAP diet

Brief summary

Irritable bowel syndrome (IBS) is a common functional gastrointestinal disorder, affecting 15% of the population. IBS is characterized by recurrent abdominal pain/discomfort without identifiable organic lesions. The pathophysiology of IBS can be multi factors which included immune activation/inflammatory reactions, visceral hypersensitivity, gastrointestinal dysmotility, changes in gut microflora, brain-gut dysfunction and food intolerance. Many short-chain carbohydrates can induce abdominal symptoms, and these carbohydrates were called, Fermentable, Oligosaccharides, Disaccharides and Monosaccharides and Polyols (FODMAPs). Around 50- 86% of the IBS patients will have a clinically meaningful response to the low-FODMAP diet. To evaluate the efficacy of low FODMAP diet. Experimental design: Health control and patients meeting the ROME III criteria for IBS will be enrolled in this study. The basic profiles, patient characteristics, intestinal microbiota profiles and MRI images will be obtained before and after low FODMAP diet intervention.

Interventions

BEHAVIORALLow FODMAP diet

Low FODMAP diet instruction to irritable bowel syndrome patients.

Sponsors

Taipei Veterans General Hospital, Taiwan
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

Patients are eligible for the study if all of the following criteria are met: 1. Patients with irritable bowel syndrome as per Rome IV diagnostic criteria Symptom characteristics of IBS according to Rome III and IV criteria 2. Patients must provide witnessed written informed consent prior to any study procedures being performed 3. Patients aged between 20-65 years 4. Male or female patients

Exclusion criteria

*

Design outcomes

Primary

MeasureTime frameDescription
irritable bowel syndrome Severity Scale (IBS-SS)Baseline, end of study approximately 6 to 8 weeks ]The primary endpoint is the variable used to assess the main objective, the efficacy of low FODMAP diet on gastrointestinal symptoms in IBS (focusing on the elimination phase) change from baseline after 6-8 weeks. The variables used will be the symptom scores of several symptom questionnaires. Ultimately, the efficacy of the diet is based on improvement of symptom scores. Improvement is defined as a 50-point drop on the Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS). In this questionnaire, each quesiton is scored from 0-100, with a maximum total score of 500. Patients reporting scores \<50 are defined as non-IBS individuals, a score from 50-175 indicated mild disease, 175-300 moderate and \>300 severe.

Contacts

Primary ContactChing-Liang Lu
cllu@vghtpe.gov.tw886228712121
Backup ContactPo-Shan Wu
pswu2@vghtpe.gov.tw886228712121

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026