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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 October 2015 |
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Main ID: |
NCT02565550 |
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Date of registration:
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30/09/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Is Microbiota Community Associated With Clinical Response to a Low FODMAP Diet in Patients With Irritable Bowel Syndrome
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Scientific title:
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Is Microbiota Community Associated With Clinical Response to a Low FODMAP Diet in Patients With Irritable Bowel Syndrome |
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Date of first enrolment:
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July 2015 |
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Target sample size:
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90 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02565550 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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China
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Contacts
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Name:
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Yanqing Li, MD.PHD |
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Address:
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Telephone:
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86-531-8216923 |
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Email:
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liyanqing@sdu.edu.cn |
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Affiliation:
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Name:
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Yanqing Li, MD.PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Qilu Hospital |
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Name:
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Yanqing Li, MD.PhD |
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Address:
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Telephone:
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86-531-82169236 |
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Email:
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liyanqing@sdu.edu.cn |
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Affiliation:
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Irritable Bowel Syndrome
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Intervention(s)
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Dietary Supplement: low FODMAPs
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Primary Outcome(s)
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changes of symptom scores
[Time Frame: 5 months]
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Secondary Outcome(s)
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microbial composition in different response to low FODMAPs
[Time Frame: 5 months]
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quality of life in IBS patients
[Time Frame: 5 months]
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proportion of responders
[Time Frame: 3 months]
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Secondary ID(s)
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2015SDU-QILU-G10
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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