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

Irritable Bowel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02565550
• Other study ID #: 2015SDU-QILU-G10
• Status: Recruiting
• Phase: Phase 4
• First received: September 30, 2015
• Last updated: September 30, 2015
• Start date: July 2015
• Est. completion date: November 2015

Study information

• Verified date: September 2015
• Source: Shandong University
• Contact: Yanqing Li, MD.PhD
• Phone: 86-531-82169236
• Email: liyanqing[@]sdu.edu.cn
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

Dietary Supplement:
• low FODMAPs
low FODMAPs means excluding food which contains oligosaccharides.disaccharides,monosaccharides, and polyols

Locations

Country	Name	City	State
China	Department of Gastroenterology, Qilu Hospital, Shandong University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes of symptom scores		5 months	No
Secondary	proportion of responders		3 months	No
Secondary	quality of life in IBS patients		5 months	No
Secondary	microbial composition in different response to low FODMAPs		5 months	No