Is Microbiota Community Associated With Clinical Response to a Low FODMAP Diet in Patients With Irritable Bowel Syndrome
1 other identifier
interventional
90
1 country
1
Brief Summary
To determine the efficacy of a low FODMAP diet in IBS patients and whether gut microbiota community is associated with its efficacy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jul 2015
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2015
CompletedFirst Submitted
Initial submission to the registry
September 30, 2015
CompletedFirst Posted
Study publicly available on registry
October 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedOctober 1, 2015
September 1, 2015
4 months
September 30, 2015
September 30, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
changes of symptom scores
5 months
Secondary Outcomes (3)
proportion of responders
3 months
quality of life in IBS patients
5 months
microbial composition in different response to low FODMAPs
5 months
Study Arms (2)
IBS patients
EXPERIMENTALeat the low FODMAPs diet for one week
healthy controls
ACTIVE COMPARATOReat the low FODMAPs diet for one week
Interventions
low FODMAPs means excluding food which contains oligosaccharides.disaccharides,monosaccharides, and polyols
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Gastroenterology, Qilu Hospital, Shandong University
Jinan, Shandong, 250012, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yanqing Li, MD.PhD
Qilu Hospital of Shandong University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Vice president of Qilu Hospital
Study Record Dates
First Submitted
September 30, 2015
First Posted
October 1, 2015
Study Start
July 1, 2015
Primary Completion
November 1, 2015
Study Completion
November 1, 2015
Last Updated
October 1, 2015
Record last verified: 2015-09