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To select among different dietary and clinical conditions the most appropriate to assess the impact of a fermented milk product on gas-related symptoms
To select among different dietary (mild or high flatulogenic diet) and clinical conditions (FGID or non-FGID population) as well as different measured parameters (self-completed questionnaires assessing gas related symptoms, digestive well-being and bowel functions, gas volume distribution in the colon by MRI, volume and composition of gas collected per anus and frequency of gas evacuations per anus), the most appropriate to assess the impact of a fermented milk product on gas-related symptoms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1=Functional Gastro-Intestinal Disorder (FGID) | Experimental | 1=FGID study group: 40 evaluable FGID subjects with a functional gastrointestinal disorder (FGID) complaining of excessive gas evacuation per anus (i.e excessive flatulence), aged from 18 to 75 years that will consume a 3-day specific and controlled mild flatulogenic diet twice at 25 days of interval (combined or not with a fermented milk product) |
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| 2=Non-FGID | Experimental | 2=Non-FGID study group: 60 evaluable non-FGID subjects aged from 18 to 75 years that will consume a 3-day specific controlled high flatulogenic diet twice at 25 days of interval (combined or not with a fermented milk product) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fermented milk product with probiotics (FMPP) | Other | 2 pots of 125g FMPP / day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in number of gas evacuations per anus | Change in number of gas evacuations per anus: number of events will be recorded daily using a gas event counter, during a 3-day baseline period and during two 3-day periods of controlled diet before and after a 28-day study product consumption period. | during a 3-day baseline period and during two 3-day periods of controlled diet before and after a 28-day study product consumption period |
| Change in intestinal gas volume | Change in intestinal gas volume: gas volume evacuated per anus will be continuously collected and measured every 15 minutes during 4 hours by a specific device, at the time of a standardized breakfast and following a 3-day period of controlled diet before and after a 28- day study product consumption period. | following a 3-day period of controlled diet before and after a 28- day study product consumption period |
| Change in intestinal gas composition | Change in intestinal gas composition: amount of different types of gas (H2, CO2, CH4, O2, N2, H2S, mercaptans) from the 4-hours intestinal gas collection sample will be determined by gas chromatography following a 3- day period of controlled diet before and after a 28-day study product consumption period. | following a 3- day period of controlled diet before and after a 28-day study product consumption period |
| Change in colonic gas volume/segmental distribution | Change in colonic gas volume/segmental distribution: total gas volume and distribution in the different regions of the colon (ascending, transverse, descending, sigmoid/rectum) will be determined using intestinal MRI following a 3-day period of controlled diet before and after a 28-day study product consumption period. | following a 3-day period of controlled diet before and after a 28-day study product consumption period |
| Gas related symptoms (self-completed questionnaire) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Vall d'Hebron - DIGESTIVE SYSTEM RESEARCH UNIT | Barcelona | 08035 | Spain |
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| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D005414 | Flatulence |
| D009085 | Mucopolysaccharidosis IV |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D043302 | Cultured Milk Products |
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D008892 | Milk |
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| 3 days |
| Digestive well-being (self-completed questionnaire) | 3 days |
| Composition of gut microbiota (molecular biology methods) | 5 days |
| Bowel function (self-completed questionnaire; bristol stool scale) | 3 days |
| D009083 | Mucopolysaccharidoses |
| D002239 | Carbohydrate Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D016464 | Lysosomal Storage Diseases |
| D017520 | Mucinoses |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D000074421 |
| Fermented Foods |
| D003611 | Dairy Products |
| D005502 | Food |
| D019602 | Food and Beverages |
| D019587 | Dietary Supplements |