The impact of dietary interventions for irritable bowel syndrome on luminal microbiota, symptoms, nutrient intake and quality of life: a randomised controlled trial

King's College London (UK)0 sites95 target enrollmentAugust 28, 2012

Overview

Registry

who.int

Start Date

August 28, 2012

End Date

September 30, 2014

Last Updated

5 years ago

Study Type

Interventional

Sex

All

Sponsor

King's College London (UK)

•1\. Men and women aged 18\-65 years with IBS\-D, IBS\-M or unsubtyped IBS based on Rome III criteria who do not have a major medical condition (diabetes, psychiatric or current eating disorders)
•2\. Gastrointestinal disease (e.g. inflammatory bowel disease, coeliac disease)
•3\. History of previous GI surgery, except cholecystectomy and haemorrhoidectomy

•1\. Females who report to be pregnant or lactating
•2\. Consumption of antibiotics, pre or probiotics (in food products or as supplements) in the last 4 weeks prior to, or during the study
•3\. Use of unpermitted medications (e.g. biological therapies)
•4\. Patients who have received bowel preparation for investigative procedures in the 4 weeks prior to the study
•5\. Patients who have had changes to IBS medications or dose in the 4 weeks prior to the study
•6\. Abdominal pain or discomfort for less than 2 days in the screening week, the frequency threshold recommended for clinical trials. Exclusion of those with minimal symptoms is recommended, and only those that experience pain on at least two days will be included.
•7\. Individuals with additional specific dietary needs