Functional Bloating (Disorder) Clinical Trial
Official title:
Gut Microbial Profiles in Fermentable Carbohydrate Induced Bloating: an Exploratory Double-blind, Randomized Cross-over, Trial
This study is an exploratory study aimed at gaining a greater understanding of the cause of abdominal bloating in response to two distinct fibre types. This is a single-center, interventional double blinded randomized cross-over study. Each participant will consume each of the study products (placebo, fibre 1 and fibre 2) for a 7-day period with a 3-week washout period in between. Outcomes will be measured before and after each intervention period.
The investigators have 4 hypotheses linked to 4 research questions that will be answered by this research: Hypothesis 1: participants with self-reported functional bloating in response to either fibre-1 or fibre-2, but not both, will respond symptomatically to fibre-1 or fibre-2, defined as 'fibre-1 responders' and 'fibre-2 responders'. Hypothesis 2: participants with functional bloating who are 'fibre-1 responders' will be distinguishable from 'fibre-1 non-responders', and 'fibre-2 responders' will be distinguishable from 'fibre-2 non-responders', based upon faecal microbial profiles identified using faecal metagenomics, transcriptomics and metabolites at baseline and following the fibre-1 and fibre-2 interventions. Hypothesis 3: the microbiota, clinical and nutritional profiles of participants with functional bloating will be interrelated and these relationships will be distinguishable between 'fibre-1 responders', 'fibre-1 non-responders', and 'fibre-2 responders' and 'fibre-2 non-responders'. Hypothesis 4: participants with visceral hypersensitivity will have different faecal microbiota and will be more likely to be a 'fibre-1 responders' or 'fibre-2 responders' than 'non-responders'. Participants in the trial will take three different dietary substances, each at a dose of 8 grams per day (split into two serves of 4 gram doses) for 7-days in a double-blinded randomised order with a 3-week washout period in between each intervention. The products are provided in powdered format and will be mixed with water before drinking. The products being provided are glucose, and fibre-1 or fibre-2 (all extracts of commonly consumed food products). ;