Effect of B-GOS on GI Discomfort in Healthy Adults
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|ClinicalTrials.gov Identifier: NCT01824667|
Recruitment Status : Completed
First Posted : April 5, 2013
Last Update Posted : November 27, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Dietary Supplement: B-GOS Dietary Supplement: Maltodextrin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Double-blind, Placebo Controlled, Randomised, Multicentered, of Parallel Design Study to Determine the Effect of B-GOS on GI Discomfort in Healthy Adults|
|Study Start Date :||February 2013|
|Actual Primary Completion Date :||November 2013|
|Actual Study Completion Date :||November 2013|
2.75g daily for 4 weeks
Dietary Supplement: B-GOS
Other Name: Bimuno
Placebo Comparator: Maltodextrin
2.75g daily for 4 weeks
Dietary Supplement: Maltodextrin
Other Name: corn syrup
- To determine the effect of B-GOS on GI discomfort [ Time Frame: Participants will be followed daily for 6 weeks ]questionnaires
- To conduct an assessment of stools [ Time Frame: Participants will be followed daily for 6 weeks. ]questionnaires
- To assess the effect of B-GOS on the quality of life and general well being. [ Time Frame: beginning and end of the study ]questionnaires
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01824667
|Research Insights Ltd|
|Oxford, United Kingdom, OX11 9LH|