Carbohydrate Reduction and Impact on Gastrointestinal System V1.0
Research type
Research Study
Full title
A pilot randomised controlled trial of the effect of a diet low in poorly digested carbohydrates on gastrointestinal form and symptoms in irritable bowel syndrome patients
IRAS ID
178576
Contact name
Robin Spiller
Contact email
Sponsor organisation
University of Nottingham
Duration of Study in the UK
1 years, 3 months, 6 days
Research summary
FODMAPs (Fermentable Oligosaccharide-Disaccharide-Monosaccharide and Polyols) are a group of poorly-digested carbohydrates found in certain cereals, fruits, vegetables, and dairy products. They are poorly absorbed by the small intestine, being subsequently fermented by bacteria in the large intestine. This results in flatulence, bloating, diarrhoea and altered bowel habit in Irritable Bowel Syndrome (IBS) patients; non-IBS sufferers rarely experience these symptoms. Some evidence suggests that reducing these dietary carbohydrates may relieve symptoms in IBS patients. Consequently, the low FODMAP diet has been recommended by the National Institute for Health and Care Excellence (NICE) as dietary management for IBS patients with persistent symptoms following general dietary and lifestyle advice. However, other research suggests that a reduction of these carbohydrates through a low FODMAPs diet might affect large intestine bacterial growth. Therefore, understanding is sought of these ideas and any effect on the bowel. We aspire to study 40 IBS patients not previously on the low FODMAPs diet. Study participants will receive dietary intervention (low FODMAPs dietary advice); this will be given by the Principal Investigator, who is a registered dietitian. Participants will be randomised into two groups: the first group receiving immediate intervention, the latter receiving delayed intervention. Both groups will be on the diet for 2 weeks, followed by dietary advice on re-introduction at different time points; a telephone follow-up will be scheduled after 3 months. Any changes to the bowel will be measured by MRI scans and breath tests; changes in symptoms will be recorded using symptom questionnaires during intervention. Additionally, dietary, quality of life and psychological information will also be collected using short questionnaires. A food diary will also be kept prior to and during intervention. The study will be conducted at the Nottingham Digestive Disease Centre, and is expected to last for 15 months.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
15/EM/0468
Date of REC Opinion
13 Nov 2015
REC opinion
Further Information Favourable Opinion