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OpenTrials
Completed

NCT Number: NCT01824667

Effect of B-GOS on GI Discomfort in Healthy Adults

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.

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Insights Ltd

Oxford, OX11 9LH, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged between 18 and 65 years old.
  • Presence of bloated feeling or experiencing abdominal fullness, with or without visible distention, often in the last 12 months.
  • Ability to communicate well with the investigator and to comply with the requirements of the entire study.
  • Volunteer has given written informed consent to participate and is willing to participate in the entire study.

Exclusion criteria

  • History or evidence of organic disease of the gastrointestinal tract; such as tumour, irritable bowel syndrome, etc., within the previous 5 years.
  • Undergone surgical resection of any part of the bowel.
  • History of malignancy within the previous 5 years (with exception of well-treated basal cell carcinoma or in situ cervical carcinoma).
  • Received antibiotics in the previous four weeks.
  • Consumed probiotic or prebiotic preparations on a regular basis (at least 3 times per week) in the last 2 weeks.
  • Former participation in another study involving prebiotic or probiotic preparations or investigational drugs within the previous one month, or intention to use such drugs during the course of the study.
  • Severe allergy or any history of severe abnormal drug reaction, drug or alcohol abuse.
  • Regular use of any medication with exception of hormonal replacement therapy and contraception.
  • Women who are pregnant or breast-feeding.
  • Fertile women not practicing a medically-approved method of contraception.

Treatment and study plan

B-GOS

Dietary Supplement

Other names: Bimuno

Maltodextrin

Dietary Supplement

Other names: corn syrup

Primary outcomes

  1. To determine the effect of B-GOS on GI discomfort

    Time frame: Participants will be followed daily for 6 weeks

    questionnaires

Secondary outcomes

  1. To conduct an assessment of stools

    Time frame: Participants will be followed daily for 6 weeks.

    questionnaires

Other outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Clasado Limited

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Apr 5, 2013
Registry last updated
Nov 27, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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