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

Jinsong Wang

Status: Unknown

Conditions: Food Habits

Treatments: Behavioral: Diet instruction; Behavioral: Low FODMAPs Diet

Study type: Interventional

Funder types: Other

Identifiers

NCT02902926

20160805

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

120 participants in 2 patient groups, including a placebo group

Low FODMAPs Diet

Experimental group

Description:

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.

Treatment:

Behavioral: Diet instruction

Behavioral: Low FODMAPs Diet

Diet Instruction

Placebo Comparator group

Description:

1.Answer doubts and correct unhealthy dietary behaviors,such as excessive diet, eating raw, spirits and other excitant food.

Treatment:

Behavioral: Diet instruction