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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
Taipei Veterans General Hospital, Taiwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Irritable Bowel Syndrome focused on measuring Low FODMAP diet

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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:

  • Exclusion criteria including:

    1. Unable to provide or understand written informed consent.
    2. Pregnancy.
    3. Receiving antibiotics or narcotics within 90 days prior to enrollment.
    4. Receiving new prebiotics, probiotics within 90 days prior to enrollment.
    5. Current infection.
    6. History of inflammatory bowel disease.
    7. Thyroid disease.
    8. Major psychiatric disorders, including clinical anxiety or depression and previous use of anxiolytics and antidepressants.
    9. Previous stroke, intracerebral hemorrhage, or central nervous system diseases.
    10. 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

    First Posted
    September 6, 2021
    Last Updated
    November 22, 2021
    Sponsor
    Taipei Veterans General Hospital, Taiwan
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    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

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

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