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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02902926
Enrollment
120
Registered
2016-09-16
Start date
2016-09-30
Completion date
2017-03-31
Last updated
2016-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Food Habits

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.

Interventions

Instruct to design and eat Low Fermentable,Oligo-,Di-,Mono-saccharides And Polyols(FODMAPs) Diet

BEHAVIORALDiet instruction

Answer the doubt and help the patient get the diet knowlege about the IBS.

Sponsors

Jinsong Wang
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Microbiota / Short chain fatty acidsChange from baseline Microbiota / Short chain fatty acids at 4 weeksThe fecal samples of IBS patients were analyzed.

Secondary

MeasureTime frameDescription
Irritable bowel syndrome severity scoring system scaleBaseline,1,and 3 month post randomizationIrritable 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
The Short Form 36 (SF-36) scaleBaseline,1,and 3 month post randomizationSF-36 is a general scale, at present, the most commonly used evaluation of IBS. It includes 36 items, a total of 8 dimensions
Irritable bowel syndrome quality of life (IBS-QOL) scaleBaseline,1,and 3 month post randomizationIrritable bowel syndrome quality of life (IBS-QOL) scale is a more extensive application of the specific scale of IBS.
Satisfaction questionnaire1,and 3 month post randomizationTo understand the patient's satisfaction with symptom control and diet guidance. The questionnaire included 3 items

Countries

China

Contacts

Primary ContactTianqi Zhou, Dr.
651299080@qq.com+8618852727248
Backup ContactYamei Gu, Dr.
286508374@qq.com15252573426

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026