NCT04802798

Pre-FIBRe Study: Predeterminants of Fibre Induced Bloating Response.

Gut Microbial Profiles in Fermentable Carbohydrate Induced Bloating: an Exploratory Double-blind, Randomized Cross-over, Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: King's College London · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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).

Conditions

• Functional Bloating (Disorder)

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Fibre 1	Food derived fibre presented as a white powder
DIETARY_SUPPLEMENT	Fibre 2	Food derived fibre presented as a white powder
DIETARY_SUPPLEMENT	Placebo	Simple sugar, presented as a white powder

Timeline

• Start date: 2021-04-19
• Primary completion: 2021-12-02
• Completion: 2021-12-02
• First posted: 2021-03-17
• Last updated: 2022-03-17

Locations

1 site across 1 country: United Kingdom