Evaluation of Treatment Effect of Low FODMAP Diet in Treatment of IBS Patients
Primary Purpose
Irritable Bowel Syndrome
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Low FODMAP diet
Sponsored by

About this trial
This is an interventional other trial for Irritable Bowel Syndrome focused on measuring Low FODMAP diet
Eligibility Criteria
Inclusion Criteria:
Patients are eligible for the study if all of the following criteria are met:
- Patients with irritable bowel syndrome as per Rome IV diagnostic criteria Symptom characteristics of IBS according to Rome III and IV criteria
- Patients must provide witnessed written informed consent prior to any study procedures being performed
- Patients aged between 20-65 years
- Male or female patients
Exclusion Criteria:
Exclusion criteria including:
- Unable to provide or understand written informed consent.
- Pregnancy.
- Receiving antibiotics or narcotics within 90 days prior to enrollment.
- Receiving new prebiotics, probiotics within 90 days prior to enrollment.
- Current infection.
- History of inflammatory bowel disease.
- Thyroid disease.
- Major psychiatric disorders, including clinical anxiety or depression and previous use of anxiolytics and antidepressants.
- Previous stroke, intracerebral hemorrhage, or central nervous system diseases.
- Malignancy.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Irritable Bowel Syndrome Patients
Arm Description
Outcomes
Primary Outcome Measures
irritable bowel syndrome Severity Scale (IBS-SS)
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05144204
First Posted
September 6, 2021
Last Updated
November 22, 2021
Sponsor
Taipei Veterans General Hospital, Taiwan
1. Study Identification
Unique Protocol Identification Number
NCT05144204
Brief Title
Evaluation of Treatment Effect of Low FODMAP Diet in Treatment of IBS Patients
Official Title
Evaluation of Treatment Effect and Mechanism of Low FODMAP Diet in Treatment of Irritable Bowel Syndrome Patients
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2021 (Anticipated)
Primary Completion Date
May 31, 2022 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Veterans General Hospital, Taiwan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
Keywords
Low FODMAP diet
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Irritable Bowel Syndrome Patients
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Low FODMAP diet
Intervention Description
Low FODMAP diet instruction to irritable bowel syndrome patients.
Primary Outcome Measure Information:
Title
irritable bowel syndrome Severity Scale (IBS-SS)
Description
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.
Time Frame
Baseline, end of study approximately 6 to 8 weeks ]
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients are eligible for the study if all of the following criteria are met:
Patients with irritable bowel syndrome as per Rome IV diagnostic criteria Symptom characteristics of IBS according to Rome III and IV criteria
Patients must provide witnessed written informed consent prior to any study procedures being performed
Patients aged between 20-65 years
Male or female patients
Exclusion Criteria:
Exclusion criteria including:
Unable to provide or understand written informed consent.
Pregnancy.
Receiving antibiotics or narcotics within 90 days prior to enrollment.
Receiving new prebiotics, probiotics within 90 days prior to enrollment.
Current infection.
History of inflammatory bowel disease.
Thyroid disease.
Major psychiatric disorders, including clinical anxiety or depression and previous use of anxiolytics and antidepressants.
Previous stroke, intracerebral hemorrhage, or central nervous system diseases.
Malignancy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ching-Liang Lu
Phone
886228712121
Email
cllu@vghtpe.gov.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Po-Shan Wu
Phone
886228712121
Email
pswu2@vghtpe.gov.tw
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Treatment Effect of Low FODMAP Diet in Treatment of IBS Patients
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