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

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02565550
Enrollment
90
Registered
2015-10-01
Start date
2015-07-31
Completion date
2015-11-30
Last updated
2015-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irritable Bowel Syndrome

Keywords

Microbiota Community, FODMAPs, IBS

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.

Interventions

DIETARY_SUPPLEMENTlow FODMAPs

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

Sponsors

Shandong University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
changes of symptom scores5 months

Secondary

MeasureTime frame
proportion of responders3 months
quality of life in IBS patients5 months
microbial composition in different response to low FODMAPs5 months

Countries

China

Contacts

Primary ContactYanqing Li, MD.PhD
liyanqing@sdu.edu.cn86-531-82169236

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026