Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
400 participants
INTERVENTIONAL
2013-02-28
2013-11-30
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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B-GOS
2.75g daily for 4 weeks
B-GOS
Maltodextrin
2.75g daily for 4 weeks
Maltodextrin
Interventions
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B-GOS
Maltodextrin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Presence of bloated feeling or experiencing abdominal fullness, with or without visible distention, often in the last 12 months.
3. Ability to communicate well with the investigator and to comply with the requirements of the entire study.
4. Volunteer has given written informed consent to participate and is willing to participate in the entire study.
Exclusion Criteria
2. Undergone surgical resection of any part of the bowel.
3. History of malignancy within the previous 5 years (with exception of well-treated basal cell carcinoma or in situ cervical carcinoma).
4. Received antibiotics in the previous four weeks.
5. Consumed probiotic or prebiotic preparations on a regular basis (at least 3 times per week) in the last 2 weeks.
6. 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.
7. Severe allergy or any history of severe abnormal drug reaction, drug or alcohol abuse.
8. Regular use of any medication with exception of hormonal replacement therapy and contraception.
9. Women who are pregnant or breast-feeding.
10. Fertile women not practicing a medically-approved method of contraception.
18 Years
65 Years
ALL
Yes
Sponsors
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Clasado Limited
INDUSTRY
Responsible Party
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Locations
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Research Insights Ltd
Oxford, , United Kingdom
Countries
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Other Identifiers
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CLAS/1213
Identifier Type: -
Identifier Source: org_study_id