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Non-absorbable, fermentable residues in the diet increase intestinal gas production and induce gas-related symptoms, such as flatulence, abdominal bloating and distention; however, prebiotics, which are also fermented by colonic bacteria, have been shown to improve this type of symptoms. The aim is to demonstrate whether a prebiotic induces adaptive changes in metabolic activity of gut microbiota and colonic biomass that explain its beneficial effect on gas-related symptoms.
Single-centre, single arm, open label, proof-of-concept study in healthy subjects. The study will consist of a pre-administration phase (2 wk), an administration phase (4 wk) and a post-administration phase (2 wk). A soluble prebiotic fiber (resistant dextrin 14 g/d) will be administered during the 4 wk administration phase. During 4 days immediately before, at the beginning and at the end of the administration phase and at the end of the post-administration phase participants will be put on a standard diet and the following outcomes will be measured: a) number of gas evacuations during daytime for 2 days by means of an event marker; b) volume of gas evacuated via a rectal tube during 4 hours after a test meal, by means of a barostat; c) microbiota composition by fecal analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy subjects | Experimental | Prebiotic administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prebiotic | Dietary Supplement | Soluble prebiotic fiber (resistant dextrin 14 g/d x 4 weeks) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of daily anal gas evacuations | Change in the number of anal gas evacuations measured by an event marker from beginning of treatment to end of treatment | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Volume of anal gas evacuation | Change in the volume of anal gas evacuated for 4 hours after a probe meal from beginning of treatment to end of treatment | 28 days |
| Microbiota composition by fecal analysis |
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Inclusion Criteria:
-
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vall d'Hebron Research Institut | Barcelona | 08035 | Spain |
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| ID | Term |
|---|---|
| D056692 | Prebiotics |
| ID | Term |
|---|---|
| D004043 | Dietary Fiber |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D011135 | Polysaccharides, Bacterial |
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Change from beginning of treatment to end of treatment
| 28 days |
| D011134 |
| Polysaccharides |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019587 | Dietary Supplements |
| D019602 | Food and Beverages |