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.
Study Type
OBSERVATIONAL
Enrollment
43
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.
Studio Pediatrico Dr. Gaetano Bottaro
Gravina di Catania, Catania, Italy
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
Time frame: 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.
Time frame: Baseline, during the intervention, immediately after the intervention
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.
Time frame: Immediately after the intervention
Evaluation of the safety profile of probiotics food supplement
Evaluation of the eventual presence adverse event/serious adverse events.
Time frame: 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
Time frame: 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;
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Time frame: BaselinaDuring the intervention, immediately after the intervention