Ignite Creation Date:
2024-05-06 @ 3:56 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04802798
Status:
COMPLETED
Last Update Posted:
2022-03-17
First Post:
2021-02-05
Brief Title:
Pre-FIBRe Study Predeterminants of Fibre Induced Bloating Response
Sponsor:
Kings College London
Organization:
Kings College London
Study Overview
Official Title:
Gut Microbial Profiles in Fermentable Carbohydrate Induced Bloating an Exploratory Double-blind Randomized Cross-over Trial
Status:
COMPLETED
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Pre-FIBRe
Brief 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None