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To evaluate the efficacy, safety and hydration index about the oral administration of probiotics food supplement in the re-equilibration of the intestinal microbiota, in presence of acute diarrhea
Multicenter, observational prospective study evaluating the efficacy, safety and index of hydration resulting from oral administration of probiotics food supplement in paediatric age.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YOVIS BIMBI | Dietary Supplement | 42 male and female subjects, aged between 3 and 14 years with acute diarrhea will be treated with Yovis BAMBINI. The 42 subjects will be recruited with a competitive enrolment at the involved study sites. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the efficacy of oral administration of probiotics food supplement in paediatric population with acute diarrhea | Reduction of the number of loose stools per day | Baseline, during the intervention, immediately after the intervention |
| Evaluation of the efficacy of oral administration of probiotics food supplement in paediatric population with acute diarrhea | Reduction of diarrhea duration. | Baseline, during the intervention, immediately after the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the safety profile of probiotics food supplement | Investigator Global Assessment of Safety (IGAS): using the 4-point scale:1= very good safety, 2 =good safety, 3 = moderate safety and 4 = poor safety. IGAS will be evaluated at the last visit. | Immediately after the intervention |
| Evaluation of the safety profile of probiotics food supplement |
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Inclusion Criteria:
• Male and female patients aged between 3 and 14 years;
Patients with one of the following conditions:
Informed consent signed by parents or the patient's legal guardian(s) for study enrollment.
Exclusion Criteria:
• Presence of chronic diarrhea characterized by the emission of poorly formed stools, for more than 4 weeks, accompanied by increased frequency of evacuation or urgency to defecation;
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42 male and female subjects, aged between 3 and 14 years with acute diarrhea will be treated with Yovis BAMBINI. The 42 subjects will be recruited with a competitive enrolment at the involved study sites.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Studio Pediatrico Dr. Gaetano Bottaro | Gravina di Catania | Catania | 95030 | Italy |
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| 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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Evaluation of the eventual presence adverse event/serious adverse events. |
| During the intervention, immediately after the intervention |
| Assessment of the compliance to the treatment | Compilation of the daily diary to the family;Compilation of the degree satisfaction questionnaires to the family;Compilation of the degree satisfaction questionnaires to the patient | During the intervention, immediately after the intervention |
| Analysis of the hydration state | Degree of dehydration using the Gorelick scale: using the 10-point score: 0 to 3 (mild dehydration), 3 to 5 (moderate dehydration), 6 to 10 (severe dehydration); Change in body weight; | BaselinaDuring the intervention, immediately after the intervention |