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

September 30, 2015 updated by: Yanqing Li, Shandong University
To determine the efficacy of a low FODMAP diet in IBS patients and whether gut microbiota community is associated with its efficacy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250012
        • Recruiting
        • Department of Gastroenterology, Qilu Hospital, Shandong University
        • Contact:
        • Sub-Investigator:
          • Jiaxin Du, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IBS patients
eat the low FODMAPs diet for one week
Dietary supplement: low FODMAPs
low FODMAPs means excluding food which contains oligosaccharides.disaccharides,monosaccharides, and polyols
Active Comparator: healthy controls
eat the low FODMAPs diet for one week
Dietary supplement: low FODMAPs
low FODMAPs means excluding food which contains oligosaccharides.disaccharides,monosaccharides, and polyols

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
changes of symptom scores
Time Frame: 5 months
5 months

Secondary Outcome Measures

Outcome Measure
Time Frame
proportion of responders
Time Frame: 3 months
3 months
quality of life in IBS patients
Time Frame: 5 months
5 months
microbial composition in different response to low FODMAPs
Time Frame: 5 months
5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shandong University

Investigators

  • Principal Investigator: Yanqing Li, MD.PhD, Qilu Hospital of Shandong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Anticipated)

November 1, 2015

Study Completion (Anticipated)

November 1, 2015

Study Registration Dates

First Submitted

September 30, 2015

First Submitted That Met QC Criteria

September 30, 2015

First Posted (Estimate)

October 1, 2015

Study Record Updates

Last Update Posted (Estimate)

October 1, 2015

Last Update Submitted That Met QC Criteria

September 30, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015SDU-QILU-G10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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