Evaluation of Treatment Effect of Low FODMAP Diet in Trea... | NCT05144204

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

NCT05144204

Sponsor

Taipei Veterans General Hospital, Taiwan

Status

Unknown status

Last Update Posted

Dec 3, 2021Actual

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Irritable Bowel Syndrome

Interventions

Low FODMAP diet

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2021Estimated

Primary Completion Date

May 31, 2022Estimated

Completion Date

Dec 31, 2023Estimated

First Submitted Date

Sep 6, 2021

First Submission Date that Met QC Criteria

Nov 22, 2021

First Posted Date

Dec 3, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 22, 2021

Last Update Posted Date

Dec 3, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Irritable Bowel Syndrome Patients	Experimental		Behavioral: Low FODMAP diet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Low FODMAP diet	Behavioral	Low FODMAP diet instruction to irritable bowel syndrome patients.	Irritable Bowel Syndrome Patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	Baseline, end of study approximately 6 to 8 weeks ]

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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:
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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ching-Liang Lu	Contact	886228712121		cllu@vghtpe.gov.tw
Po-Shan Wu	Contact	886228712121		pswu2@vghtpe.gov.tw

Overall Officials

Not provided

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D043183	Irritable Bowel Syndrome

Ancestor Terms

ID	Term
D003109	Colonic Diseases, Functional
D003108	Colonic Diseases
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000092622	FODMAP Diet

Ancestor Terms

ID	Term
D000092724	Elimination Diets
D004032	Diet
D009747	Nutritional Physiological Phenomena
D000066888	Diet, Food, and Nutrition

Browse Leaves

Not provided

Browse Branches

Not provided