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

Shandong University

Status and phase: Unknown; Phase 4

Conditions: Irritable Bowel Syndrome

Treatments: Dietary Supplement: low FODMAPs

Study type: Interventional

Funder types: Other

Identifiers

NCT02565550

2015SDU-QILU-G10

Details and patient eligibility

About

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

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

IBS patients

Experimental group

Description:

eat the low FODMAPs diet for one week

Treatment:

Dietary Supplement: low FODMAPs

healthy controls

Active Comparator group

Description:

eat the low FODMAPs diet for one week

Treatment:

Dietary Supplement: low FODMAPs