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Is Microbiota Community Associated With Clinical Response to a Low FODMAP Diet in Patients With Irritable Bowel Syndrome

Primary Purpose

Irritable Bowel Syndrome

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

low FODMAPs

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring Microbiota Community, FODMAPs, IBS

Eligibility Criteria

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

Inclusion Criteria:

the presence of Rome III criteria for IBS ;
Patients scheduled for colonoscopy examination or having negative screening examinations
Aged between 18 and 65 years old

Exclusion Criteria:

Antibiotic, probiotic or laxative usage within 4 weeks.
organic gastrointestinal diseases
Severe systematic disease: diabetes mellitus, hepatic, renal or cardiac dysfunction, thyroid disease or tumor etc.
pregnancy or lactation.
previous major or complicated abdominal surgery.
severe endometriosis and dementia

Sites / Locations

Department of Gastroenterology, Qilu Hospital, Shandong UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

IBS patients

healthy controls

Arm Description

eat the low FODMAPs diet for one week

Outcomes

Primary Outcome Measures

changes of symptom scores

Secondary Outcome Measures

proportion of responders

quality of life in IBS patients

microbial composition in different response to low FODMAPs

Full Information

NCT ID

NCT02565550

First Posted

September 30, 2015

Last Updated

September 30, 2015

Sponsor

Shandong University

1. Study Identification

Unique Protocol Identification Number

NCT02565550

Brief Title

Is Microbiota Community Associated With Clinical Response to a Low FODMAP Diet in Patients With Irritable Bowel Syndrome

Official Title

Is Microbiota Community Associated With Clinical Response to a Low FODMAP Diet in Patients With Irritable Bowel Syndrome

Study Type

Interventional

2. Study Status

Record Verification Date

September 2015

Overall Recruitment Status

Unknown status

Study Start Date

July 2015 (undefined)

Primary Completion Date

November 2015 (Anticipated)

Study Completion Date

November 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shandong University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

To determine the efficacy of a low FODMAP diet in IBS patients and whether gut microbiota community is associated with its efficacy.

Detailed Description

We seek to determine whether a low FODMAPs diet decreases symptoms in irritable bowel syndrome (IBS)patients and to identify potential microbial factors related to diet efficacy. Pain symptoms, stooling characteristics, breath hydrogen, stool microbiome will be collected and/or documented in IBS patients at baseline and during one week of an low FODMAPs intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Irritable Bowel Syndrome

Keywords

Microbiota Community, FODMAPs, IBS

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

IBS patients

Arm Type

Experimental

Arm Description

eat the low FODMAPs diet for one week

Arm Title

healthy controls

Arm Type

Active Comparator

Arm Description

eat the low FODMAPs diet for one week

Intervention Type

Dietary Supplement

Intervention Name(s)

low FODMAPs

Intervention Description

low FODMAPs means excluding food which contains oligosaccharides.disaccharides,monosaccharides, and polyols

Primary Outcome Measure Information:

Title

changes of symptom scores

Time Frame

5 months

Secondary Outcome Measure Information:

Title

proportion of responders

Time Frame

3 months

Title

quality of life in IBS patients

Time Frame

5 months

Title

microbial composition in different response to low FODMAPs

Time Frame

5 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: the presence of Rome III criteria for IBS ; Patients scheduled for colonoscopy examination or having negative screening examinations Aged between 18 and 65 years old Exclusion Criteria: Antibiotic, probiotic or laxative usage within 4 weeks. organic gastrointestinal diseases Severe systematic disease: diabetes mellitus, hepatic, renal or cardiac dysfunction, thyroid disease or tumor etc. pregnancy or lactation. previous major or complicated abdominal surgery. severe endometriosis and dementia

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yanqing Li, MD.PhD

Phone

86-531-82169236

Ext

86-531-8216923

liyanqing@sdu.edu.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yanqing Li, MD.PhD

Organizational Affiliation

Qilu Hospital of Shandong University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Gastroenterology, Qilu Hospital, Shandong University

City

Jinan

State/Province

Shandong

ZIP/Postal Code

250012

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yanqing Li, MD.PHD

Phone

86-531-8216923

Ext

86-531-8216923

liyanqing@sdu.edu.cn

First Name & Middle Initial & Last Name & Degree

Jiaxin Du, MD

12. IPD Sharing Statement

Learn more about this trial

Is Microbiota Community Associated With Clinical Response to a Low FODMAP Diet in Patients With Irritable Bowel Syndrome

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