Comparison of Microbiota and Quality of Life for a Low FODMAPs and Standard Dietary in Irritable Bowel Syndrome Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison of Microbiota and Quality of Life for a Low FODMAPs Versus Standard Dietary Advice in Patients With Irritable Bowel Syndrome

Conditions
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Food Habits

Intervention / Treatment
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* Behavioral: Low FODMAPs Diet
* Behavioral: Diet instruction


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low FODMAPs Diet<br>Instructed to low FODMAPs diet when patients signed the informed consent. Answer doubts and correct unhealthy dietary behaviors,such as excessive diet, eating raw, spirits and other excitant food. | Behavioral: Low FODMAPs Diet<br>* Instruct to design and eat Low Fermentable，Oligo-，Di-，Mono-saccharides And Polyols(FODMAPs) Diet<br>Behavioral: Diet instruction<br>* Answer the doubt and help the patient get the diet knowlege about the IBS.<br>|
| Placebo Comparator: Diet Instruction<br>1.Answer doubts and correct unhealthy dietary behaviors,such as excessive diet, eating raw, spirits and other excitant food. | Behavioral: Diet instruction<br>* Answer the doubt and help the patient get the diet knowlege about the IBS.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbiota / Short chain fatty acids | The fecal samples of IBS patients were analyzed. | Change from baseline Microbiota / Short chain fatty acids at 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Irritable bowel syndrome severity scoring system scale | Irritable bowel syndrome severity scoring system scale is an integral system for monitoring the severity of IBS in patients with disease severity.The scale is mainly from the degree of abdominal pain, abdominal pain frequency, abdominal distension, defecation satisfaction and the impact of life, according to the 10cm visual scoring method | Baseline,1,and 3 month post randomization | 
| The Short Form 36 (SF-36) scale | SF-36 is a general scale, at present, the most commonly used evaluation of IBS. It includes 36 items, a total of 8 dimensions | Baseline,1,and 3 month post randomization | 
| Irritable bowel syndrome quality of life (IBS-QOL) scale | Irritable bowel syndrome quality of life (IBS-QOL) scale is a more extensive application of the specific scale of IBS. | Baseline,1,and 3 month post randomization | 
| Satisfaction questionnaire | To understand the patient's satisfaction with symptom control and diet guidance. The questionnaire included 3 items | 1,and 3 month post randomization |