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

NCT ID: NCT05144204

Last Updated: 2021-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-01

Study Completion Date

2023-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Irritable Bowel Syndrome

Keywords

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Low FODMAP diet

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Irritable Bowel Syndrome Patients

Group Type EXPERIMENTAL

Low FODMAP diet

Intervention Type BEHAVIORAL

Low FODMAP diet instruction to irritable bowel syndrome patients.

Interventions

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Low FODMAP diet

Low FODMAP diet instruction to irritable bowel syndrome patients.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Ching-Liang Lu

Role: CONTACT

Phone: 886228712121

Email: [email protected]

Po-Shan Wu

Role: CONTACT

Phone: 886228712121

Email: [email protected]

Other Identifiers

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2018-07-023B

Identifier Type: -

Identifier Source: org_study_id