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

Not Applicable

• Conditions: Food Habits
• Interventions: Behavioral: Low FODMAPs Diet; Behavioral: Diet instruction

• Registration Number: NCT02902926
• Lead Sponsor: Jinsong Wang

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.

Study Timeline

• Study First Submitted: 2016-08-15
• Status Verified: 2016-09
• Study Start: 2016-09
• Study First Submitted QC: 2016-09-12
• Last Update Submitted: 2016-09-12
• Study First Posted: 2016-09-16
• Last Update Posted: 2016-09-16
• Primary Completion: 2016-12
• Study Completion: 2017-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low FODMAPs Diet	Diet instruction	1. Instructed to low FODMAPs diet when patients signed the informed consent. 2. Answer doubts and correct unhealthy dietary behaviors,such as excessive diet, eating raw, spirits and other excitant food.
Diet Instruction	Diet instruction	1.Answer doubts and correct unhealthy dietary behaviors,such as excessive diet, eating raw, spirits and other excitant food.
Low FODMAPs Diet	Low FODMAPs Diet	1. Instructed to low FODMAPs diet when patients signed the informed consent. 2. Answer doubts and correct unhealthy dietary behaviors,such as excessive diet, eating raw, spirits and other excitant food.

Primary Outcome Measures

Name	Time	Method
Microbiota / Short chain fatty acids	Change from baseline Microbiota / Short chain fatty acids at 4 weeks	The fecal samples of IBS patients were analyzed.

Secondary Outcome Measures

Name	Time	Method
The Short Form 36 (SF-36) scale	Baseline,1,and 3 month post randomization	SF-36 is a general scale, at present, the most commonly used evaluation of IBS. It includes 36 items, a total of 8 dimensions
Satisfaction questionnaire	1,and 3 month post randomization	To understand the patient's satisfaction with symptom control and diet guidance. The questionnaire included 3 items
Irritable bowel syndrome severity scoring system scale	Baseline,1,and 3 month post randomization	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
Irritable bowel syndrome quality of life (IBS-QOL) scale	Baseline,1,and 3 month post randomization	Irritable bowel syndrome quality of life (IBS-QOL) scale is a more extensive application of the specific scale of IBS.

Trial Locations

Locations (1)

YangzhouUniversity; 🇨🇳 Yangzhou, Jiangsu, China