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The purpose of the study is to establish an in-vitro method to evaluate the effect of probiotics on gas production in feces (hydrogen and methane)
The objective of this study is to establish a model for screening probiotic bacteria in the treatment of meteorism symptoms (feeling of air in the stomach) with otherwise healthy adult women. As excessive bacterial gas production in the intestine is the most likely mechanism behind meteorism, we will examine eventual changes of the production of gases (hydrogen and methane) before and after administration of Trevis®. For screening of Trevis® we will apply a combination of clinical examination and a laboratory model for the determination of gastrointestinal gas production (a new method in connection with studies on probiotics). The results will be compared with the test person's specification of their health, both with respect to gastrointestinal function and in general through questionnaires. The background for the project will be described in the following.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic bacteria (Trevis R) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| In-vitro production (quantified) of hydrogen and methane in feces | ||
| Recovery of ingested bacteria in feces by PCR |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life (SF36-danish version) | ||
| VAS-scores for bloating, distention, abdominal pain, abdominal discomfort, flatulence | ||
| Abdominal height in lying position, waist circumference, weight |
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Inclusion Criteria:
- Female test persons with symptoms of meteorism, the age of > 18 years, completely integrated in the Danish society (including nutrition), and no previous abdominal surgery besides from appendicectomy (advertisement in a local newspaper for test persons).
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jens R Andersen, MD | Contact | +45 3528 2504 | jra@kvl.dk | |
| Julie Schrøder, student | Contact | +45 3528 2487 | juliebs@dsr.kvl.dk |
| Name | Affiliation | Role |
|---|---|---|
| Jens R Andersen, MD | Dept. Human Nutrition, The Royal Veterinary and Agricultural University, Copenhagen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept. Human Nutrition, The Royal Veterinary and Agricultural University | Recruiting | Copenhagen | DK-1958-FC | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 1556190 | Background | Strocchi A, Levitt MD. Factors affecting hydrogen production and consumption by human fecal flora. The critical roles of hydrogen tension and methanogenesis. J Clin Invest. 1992 Apr;89(4):1304-11. doi: 10.1172/JCI115716. |
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| D004066 | Digestive System Diseases |