Status:
COMPLETED
Effect of B-GOS on GI Discomfort in Healthy Adults
Lead Sponsor:
Clasado Limited
Conditions:
Healthy
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief 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 pa...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT01824667
Start Date
February 1 2013
End Date
November 1 2013
Last Update
November 27 2013
Active Locations (1)
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1
Research Insights Ltd
Oxford, United Kingdom, OX11 9LH