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It has been shown that patients complaining of gas-related symptoms significantly improve on a diet low in fermentable residues. However, other studies suggest that some non-absorbable, fermentable meal products (prebiotics) that serve as substrate to colonic bacteria, produce beneficial effects to the host, including improvement of abdominal symptoms. The aim of the study is to compare the effects of a diet low in fermentable residues versus a diet suplemented with prebiotics on intestinal microbiota composition, microbiota activity (intestinal gas production) and digestive symptoms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bimuno Galacto-oligosaccharide | Experimental | Dietary intervention |
|
| Low- FODMAPs diet | Placebo Comparator | Dietary intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bimuno Galacto-oligosaccharide 1.37 g/d | Dietary Supplement | Prebiotic versus low-FODMAPs diet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Gut microbiota composition | Effect of treatment on the response of microbiota to 3-day challenge diet | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Microbiota activity (intestinal gas production) | Intestinal gas evacuation on standardized diet | 28 days |
| Digestive symptoms | Digestive sensations measured by scales |
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Inclusion Criteria:
Functional digestive disorder with flatulence
Women and men between the ages of 18 and 80 years (bounds included at the inclusion visit).
Normal body weight or with overweight (body mass index between 18.0 and 30.0 kg/m2 (bounds included)).
Women of childbearing potential should be using or complying with one of the medically approved methods of contraception such as, but not exclusively, one of the following:
Willing to follow strict dietary instructions for the duration of the study
Able to communicate well with the investigator and to comply with the requirements for the study.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fernando Azpiroz, MD | Hospital Universitari Vall d'Hebron Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vall d'Hebron Research Institute | Barcelona | Barcelona | 08035 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29964041 | Derived | Huaman JW, Mego M, Manichanh C, Canellas N, Canueto D, Segurola H, Jansana M, Malagelada C, Accarino A, Vulevic J, Tzortzis G, Gibson G, Saperas E, Guarner F, Azpiroz F. Effects of Prebiotics vs a Diet Low in FODMAPs in Patients With Functional Gut Disorders. Gastroenterology. 2018 Oct;155(4):1004-1007. doi: 10.1053/j.gastro.2018.06.045. Epub 2018 Jun 30. |
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| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000092622 | FODMAP Diet |
| ID | Term |
|---|---|
| D000092724 | Elimination Diets |
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
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| Low- FODMAPs diet | Dietary Supplement |
|
| 28 days |
| D010829 | Physiological Phenomena |