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

NCT04802798 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2022-03-17

No results posted yet for this study

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.

Conditions

  • Functional Bloating (Disorder)

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Kevin Whelan, PhD · King's College London

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-19
Primary Completion
2021-12-02
Completion
2021-12-02

Countries

  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04802798 on ClinicalTrials.gov