NCT01824667

Effect of B-GOS on GI Discomfort in Healthy Adults

Double-blind, Placebo Controlled, Randomised, Multicentered, of Parallel Design Study to Determine the Effect of B-GOS on GI Discomfort in Healthy Adults

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 400 (actual)
• Sponsor: Clasado Limited · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The aim of the study is to evaluate the effects of a new food supplement which is currently available in the market, called Bimuno® (B-GOS), on gastrointestinal discomfort (e.g. bloating, abdominal pain/cramp and flatulence) in adults who often experience these symptoms but are otherwise healthy. About 400 volunteers will take part in this study, which will last 6 weeks (to include 4 weeks treatment and 2 weeks follow up period). Episodes of abdominal pain or discomfort (e.g. bloating, abdominal pain/cramp and flatulence), in the absence of diseases, are commonly associated with food or drug intake or with alterations of bowel habit and vary between individuals in frequency and severity. Some dietary ingredients are known to reduce these symptoms. We have used B-GOS previously in trials with healthy younger and older adults and we have observed a trend towards reducing abdominal bloating. However, the investigators have not tested B-GOS in healthy adults who often experience these symptoms and this is what we will investigate now.

Conditions

• Healthy

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	B-GOS
DIETARY_SUPPLEMENT	Maltodextrin

Timeline

• Start date: 2013-02-01
• Primary completion: 2013-11-01
• Completion: 2013-11-01
• First posted: 2013-04-05
• Last updated: 2013-11-27

Locations

1 site across 1 country: United Kingdom