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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| B-GOS | Experimental | 2.75g daily for 4 weeks |
|
| Maltodextrin | Placebo Comparator | 2.75g daily for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| B-GOS | Dietary Supplement |
|
| |
| Maltodextrin |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the effect of B-GOS on GI discomfort | questionnaires | Participants will be followed daily for 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To conduct an assessment of stools | questionnaires | Participants will be followed daily for 6 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the effect of B-GOS on the quality of life and general well being. | questionnaires | beginning and end of the study |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Insights Ltd | Oxford | OX11 9LH | United Kingdom |
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| ID | Term |
|---|---|
| C008315 | maltodextrin |
| D066248 | High Fructose Corn Syrup |
| ID | Term |
|---|---|
| D000073417 | Dietary Sugars |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D000073893 | Sugars |
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| Dietary Supplement |
|
|
| D064427 |
| Nutritive Sweeteners |
| D013549 | Sweetening Agents |
| D005421 | Flavoring Agents |
| D005503 | Food Additives |
| D000074385 | Food Ingredients |
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |