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| Name | Class |
|---|---|
| Adventia Pharma | INDUSTRY |
| Biopolis S.L. | INDUSTRY |
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This is a randomized, multicenter, translational, triple-blind, clinical trial in patients with Crohn's disease, who will be prescribed an oral nutritional supplement to control symptoms in the acute phase and to recover in the remission phase.
Multicentric, parallel, randomized, double blind and controlled clinical-nutritional study of 6 months of intervention and 3 study groups of treatment: Experimental group (peptidic diet with a mix of probiotics); Experimental group with placebo (peptidic diet with a placebo); and Control group (control with a polymeric nutritional oral supplement with a placebo) to evaluate the effect on the nutritional status, inflammatory markers and the intestinal absorption
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peptidic+Probiotic | Active Comparator | Nutritional intervention and dietary recommendations. Consumption of 2 tetra paks/day of a specific oral nutritional supplement and mix of probiotics during 6 months |
|
| Peptidic+Placebo | Active Comparator | Nutritional intervention and dietary recommendations. Consumption of 2 tetra paks/day of a specific oral nutritional supplement and placebo during 6 months |
|
| Polymeric+Placebo | Placebo Comparator | Nutritional intervention and dietary recommendations. Consumption of 2 tetra paks/day of a specific oral nutritional supplement and placebo during 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peptidic+Probiotic | Dietary Supplement | Oligomeric oral nutritional supplement (Bi1 peptidic) and a mix of probiotics
|
| Measure | Description | Time Frame |
|---|---|---|
| Malabsorption | Body Weight Change (kg) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the consistency of the stools according to Bristol scale. | Bristol scale: type 1= separate hard lumps, type 2= sausage shaped but lumpy, type 3= like a sausage but with cracks on ots surface, type 4= like a sausage or sanake, smooth and soft, type 5= soft blobs with clear cut-edges, type 6= fluffy pieces with ragged edges, a mushy stool, type 7 = watery, no solid pieces. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Miguel A Aganzo-Yeves, RD | Contact | +34661774925 | miguel.aganzo@fjd.es |
| Name | Affiliation | Role |
|---|---|---|
| Miguel Aganzo-Yeves, RD | Hospital Universitario Fundación Jiménez DÃaz | Principal Investigator |
| Clotilde Vázquez-MartÃnez, MD | Hospital Universitario Fundación Jiménez DÃaz | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miguel Aganzo Yeves | Recruiting | Madrid | 28040 | Spain |
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| Peptidic+Placebo | Dietary Supplement | Oligomeric oral nutritional supplement (Bi1 peptidic) and a placebo |
|
| Polymeric+Placebo | Dietary Supplement | Polymeric oral nutritional supplement and a placebo |
|
| Fat malabsorption | Presence of fat in the stool | 6 months |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| C564245 | Platelet Glycoprotein IV Deficiency |
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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