Clinical trial NCT02902926: Comparison of Microbiota and Quality of Life for a Low FODMAPs and Standard Dietary in Irritable Bowel Syndrome Patients
Official title: Comparison of Microbiota and Quality of Life for a Low FODMAPs Versus Standard Dietary Advice in Patients With Irritable Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Food Habits
Lead sponsor: Yangzhou University
Sponsor class: OTHER
First posted: 2016-09-16
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: IBS is a global disease, patients often because of long-term symptoms of recurrent, not timely diagnosis and treatment effect is not ideal and frequent treatment, seriously affect the quality of life, and cause the corresponding economic and social burden.At present，a number of studies suggest that fermentable oligosaccharides, disaccharides and monosaccharides and polyols (FODMAPs) can induce IBS symptoms.Data from large randomized controlled trials are limited, leaving clinicians with the challenge of providing patients with reliable guidance based on minimal evidence.

Detailed description: IBS is a global disease, patients often because of long-term symptoms of recurrent, not timely diagnosis and treatment effect is not ideal and frequent treatment, seriously affect the quality of life, and cause the corresponding economic and social burden.At present，a number of studies suggest that fermentable oligosaccharides, disaccharides and monosaccharides and polyols (FODMAPs) can induce IBS symptoms.Data from large randomized controlled trials are limited, leaving clinicians with the challenge of providing patients with reliable guidance based on minimal evidence.

This study will compare the effect of low FODMAPs diet and usual diet instruction on Intestinal flora, intestinal short chain fatty acids and quality of life by two groups.The results will answer the effect and long-term safety of Low FODMAPs diet.

Eligibility criteria: Inclusion Criteria:

* Diagnostic criteria for Rome Ⅲ
* IBS patients with diarrhea type
* By endoscopy, X-ray, B ultrasound and laboratory examination to exclude organic disease
* Patients be able to communicate well with the researchers and be willing to participate in the study

Exclusion Criteria:

* Stomach, small intestine, colon surgery history
* irritable bowel disease (IBD) active period, celiac disease
* Alcoholics or drug abuse
* Pregnant or lactating women
* Recent drug users who use defecation
* Have a special diet

Primary outcomes:
measure: Microbiota / Short chain fatty acids
timeFrame: Change from baseline Microbiota / Short chain fatty acids at 4 weeks
Secondary outcomes:
measure: Irritable bowel syndrome severity scoring system scale
timeFrame: Baseline,1,and 3 month post randomization
measure: The Short Form 36 (SF-36) scale
timeFrame: Baseline,1,and 3 month post randomization
measure: Irritable bowel syndrome quality of life (IBS-QOL) scale
timeFrame: Baseline,1,and 3 month post randomization
measure: Satisfaction questionnaire
timeFrame: 1,and 3 month post randomization
Other outcomes:
Locations:
city: Yangzhou
country: China
facility: YangzhouUniversity
state: Jiangsu
Study officials:
affiliation: Medical College
name: Hongcan Shi, Ph.D.,M.D.
role: STUDY_CHAIR
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