FOGA Randomised Controlled Trial of the Effect of the Low FODMAP Diet and Dietary Oligofructose on Gastrointestinal Form, Function and Microbiota in Healthy Volunteers
low FODMAP diet
+ Maltodextrin
+ Oligofructose
Maladies du côlon+3
+ Maladies Fonctionnelles du Côlon
+ Maladies du système digestif
Recherche fondamentale
Résumé
Date de début de l'étude : 1 septembre 2014
Date à laquelle le premier participant a commencé l'étude.Oligofructose (OF) is a fructose- based oligosaccharide and defined in the European Union as a dietary fibre. Enzymatically derived from the longer chain inulin in chicory, it is commonly used in processed food to improve mouth feel in fat-free products. OF is poorly digested and absorbed in the small bowel so passes to the colon where it is fermented by the bacteria usually resident in the colon, termed the microbiota. This process produces gases such as hydrogen and sometimes methane, and short-chain fatty acids (SCFAs) which have a variety of roles including nutrition to colonocytes, immunological effects and modulation of intestinal motility. Its presence in the colon alters the composition of the microbiota, with reported potential benefits to health, leading to its description as a 'prebiotic'. Recently, however, such poorly digested carbohydrates grouped together by the term FODMAP (fermentable oligo-, di-, mono-saccharides and polyols) have been proposed to exacerbate symptoms of irritable bowel syndrome (IBS) such as abdominal discomfort and bloating. Dietary exclusion of foods containing FODMAPs, such as wheat, dairy and certain fruit and vegetables, has been proposed as a treatment for IBS, with some evidence to support this. FODMAPs are thought to induce symptoms either by drawing water into the small bowel by osmosis, or through gaseous distension of the large bowel or a combination of these along with metabolite effects on motility. The Nottingham GI MRI group has been at the forefront of elucidating the actual effects of FODMAPs on gastrointestinal (GI) physiology. We have published techniques to measure small bowel water content, colonic volume and gas volume and whole gut transit time. We have recently demonstrated that a single, large (40g) dose of inulin leads to an increase in colonic volume, mainly through an increase in colonic gas. Such a dose is beyond the usual range of dietary variation, however. Last year we piloted a model more similar to dietary practice. Participants supplemented their usual diet with 5g OF twice daily for a week. The most striking result was an 18% increase in fasting colonic volume. This could not be explained by changes in colonic gas and may represent proliferation, and increased mass, of the microbiota. That study was an open label, uncontrolled case series so we now wish to test the hypothesis in a double-blind, randomised controlled trial. For explanatory purposes we will also measure whole gut transit, colonic gas volume and hydrogen and methane expired in the breath. For exploratory purposes we will also collect stool and urine samples to allow assessment of the effect on microbiota and their metabolic output.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.45 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Recherche fondamentale
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.À partir de 18 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.2 groupes d'intervention sont désignés dans cette étude
50% de chances d'être dans le groupe placebo en aveugle
Groupes de traitement
Groupe I
PlaceboGroupe II
Comparateur actifObjectifs de l'étude
Objectifs principaux
Objectifs secondaires
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site
Nottingham Digestive Diseases Centre
Nottingham, United KingdomOuvrir Nottingham Digestive Diseases Centre dans Google Maps