Status:
COMPLETED
Efficacy of Low-FODMAPs Dietary Therapy for Irritable Bowel Syndrome in China
Lead Sponsor:
Sir Run Run Shaw Hospital
Collaborating Sponsors:
Zhejiang Academy of Agricultural Sciences
University of Michigan
Conditions:
Irritable Bowel Syndrome
Diet Modification
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The primary aim of our study is to carry out a randomized trial to evaluate the efficacy of low-FODMAPs dietary therapy compared to conventional therapy for IBS patients recruited from tertiary hospit...
Detailed Description
Visit 1：Enrollment \& Screening \& Run-in period Patients who meet the inclusion criteria will be asked to complete IBS Baseline Assessment Questionnaires according to Rome III.Subjects that meet the ...
Eligibility Criteria
Inclusion
- 18-65 years old.
- Meet Rome Rome III criteria for IBS-D.
- All these patients should have no abnormality in blood, stool analysis or colonoscopy within the previous 2 years.
- No GI alarm symptoms.
Exclusion
- Presence of a severe cardiac, hepatic, nephritic, neurologic disease.
- Presence of mental disorders caused by schizophrenia, organic brain disorder or physical disease.
- Other comorbid medical conditions (eg.unstable diabetes, unstable thyroid disease).
- Previous abdominal surgery except appendectomy or hysterectomy.
- Pregnant or lactating women.
- Use of probiotics, prebiotics, lactulose, antidiarrheal agents or bowel preparation within the 4 weeks prior to the study.
- Participation in any other form of dietary therapy within the 4 weeks prior to the study.
- Difficulties in communication.
Key Trial Info
Start Date :
October 10 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2019
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT03304041
Start Date
October 10 2017
End Date
May 31 2019
Last Update
September 12 2019
Active Locations (1)
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1
Sir Run Run Shaw Hospital , College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310016