A Low FODMAP diet for diarrhoea predominant FGID in NET patients
Research type
Research Study
Full title
A Low FODMAP diet for diarrhoea predominant functional gastrointestinal disorders in pancreatic and mid-gut neuroendocrine tumour patients
IRAS ID
123595
Contact name
Martyn Caplin
Contact email
Sponsor organisation
Royal Free London NHS Foundation Trust
Research summary
The aims of this study are to determine if a low fermentable oligosaccharide, disaccharide, monosaccharide and polyol (FODMAP) is useful in controlling functional gastrointestinal disorders (FGID) in mid-gut and pancreatic Neuroendocrine Tumour (NET) patients. The evidence could be used to form future guidelines for Dietitians who work in this area of cancer care.
Primary Objective:
Does a 4 week Low FODMAP diet affect diarrhoea frequency in susceptible NET patients?
Secondary Objectives:
Does a 4 week long Low FODMAP diet affect quality of life in NET patients?
Does a 4 week long Low FODMAP diet affect body weight of NET patients?
The study will be of non-blind controlled interventional methodology. The study and control groups will consist of mid-gut and pancreatic NET patients who have a diarrhoea predominant FGID. These patients will be randomised into two groups: Group A will be given a 4 week trial of the low FODMAP diet and group B, the control group, receiving standard care will be given a ‘Nutrition in NET’s’ booklet which will be discussed with them. The Bristol Stool Chart score, quality of life and weight are the outcome measures for both groups which are measured on the first day of consent, face to face and 4 weeks after starting the diet, over the telephone. Diet histories will also be taken for both groups at both time points but are not outcome measures.
A Low FODMAP diet reduces the amount of fermentable carbohydrates which commonly cause luminal distension and diarrhoea. Certain NET patients, with less adaptable bowels and/or visceral hypersensitivity may develop absorption difficulties resulting in diarrhoea predominant IBS-like symptoms when they eat/drink FODMAPS.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
13/LO/1506
Date of REC Opinion
13 Dec 2013
REC opinion
Further Information Favourable Opinion