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| Name | Class |
|---|---|
| Colisée Barcelona Isabel Roig | UNKNOWN |
| Grupo Colisée | UNKNOWN |
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Efficacy and tolerability of ABB i5 prebiotic and ABB C22 postbiotics for the management of constipation and gastrointestinal well-being: a pilot trial
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABB S3 - active | Experimental | Postbiotic ABB S3 for suspension into Nutritional supplementation with Medical Nutrition Formula for the management of gastrointestinal symptoms secondary to enteral nutrition |
|
| ABB S3 - Placebo | Placebo Comparator | Placebo for suspension into Nutritional supplementation with Medical Nutrition Formula for the management of gastrointestinal symptoms secondary to enteral nutrition |
|
| ABB C22 - active | Experimental | Oral Rehydration Solution containing postbiotics ABB C22 for the management of diarrhoea signs of dehydration |
|
| ABB C22 - placebo | Placebo Comparator | Oral Rehydration Solution containing placebo for the management of diarrhoea signs of dehydration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABB S3 | Dietary Supplement | Postbiotic ABB S3 for suspension into Nutritional supplementation with Medical Nutrition Formula for the management of gastrointestinal symptoms secondary to enteral nutrition |
| Measure | Description | Time Frame |
|---|---|---|
| Faecal calprotectin | change in faecal calprotectin levels (mg/g) | from baseline to day 14 of supplementation |
| faecal lactoferrin | change in the number of participants with a positive "faecal lactoferrin" result (%) | from baseline to day 14 of supplementation |
| Blood IgAs | levels of serum IgAs (mg/dL) | from baseline to day 14 of supplementation |
| Measure | Description | Time Frame |
|---|---|---|
| Gastrointestinal symptoms | assessment of number of diarrhea, vomits and regurgitation events | from baseline to day 14 of supplementation |
| faecal consisitency | assessed through Bristol scale (1-7 score) |
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Inclusion Criteria:
Inpatients of the centre
Exclusion Criteria:
History of allergy, idiosyncrasy, hypersensitivity or adverse reactions to the active principle or to any of the excipients.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Isabel Roig | Barcelona | Barcelona | 0803' | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40126284 | Derived | Mateus Rodriguez JA, Rodriguez Sanz P, Kostandyan E, Palacios Sanchez R, Pino Roque ML, Chaves Vasquez P, Roy Millan P. Mitigating Diarrhoea-Related Inflammation in Frail Older Adults with Postbiotic-Enhanced Oral Rehydration Solution: Insights from a Randomised, Double-Blind, Placebo-Controlled Study. Geriatrics (Basel). 2025 Mar 1;10(2):34. doi: 10.3390/geriatrics10020034. |
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Biomarkers data (calprotectin, lactoferrin, igA) data, Bristol scale data
According to legislation
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| ABB C22 | Dietary Supplement | Oral Rehydration Solution containing postbiotics ABB C22 for the management of diarrhoea signs of dehydration |
|
| Placebo | Dietary Supplement | Placebo for suspension into Nutritional supplementation with Medical Nutrition Formula for the management of gastrointestinal symptoms secondary to enteral nutrition |
|
| Placebo | Dietary Supplement | Oral Rehydration Solution containing placebo for the management of diarrhoea signs of dehydration |
|
| from baseline to day 14 of supplementation |
| ID | Term |
|---|---|
| D003967 | Diarrhea |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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