Study for Evaluation of Probiotics in the Re-equilibration of the Intestinal Microbiota, in Paediatric Age

NCT ID: NCT06403358

Last Updated: 2024-05-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 43 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-11-28
• Study Completion Date: 2024-01-30

Brief Summary

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

Detailed Description

Multicenter, observational prospective study evaluating the efficacy, safety and index of hydration resulting from oral administration of probiotics food supplement in paediatric age.

Conditions

Diarrhea

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

YOVIS BIMBI

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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• • Male and female patients aged between 3 and 14 years;

• Patients with one of the following conditions:

• Population with acute diarrhea;
• Occurrence of at list three liquid or loose stools per day;
• Consistency of stools (≥ type 5) according to Bristol Stool Scale Form (BFS).
• 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;

• Known or potential hypersensitivity and/or history of allergic reactions to one of the components of probiotics food supplement;
• Coexisting severe infection (e.g. sepsis, pneumonia, meningitis);
• Patients affected by chronic intestinal disease, immune deficiency, neurological disease and tumors;
• Contemporary consumption of other probiotics compounds;
• Patients whose parents or the patient's legal guardian(s)refuse to provide written informed consent;
• Patient who has not expressed his consent according to his age and level of understanding;
• Participation in another clinical trial within the previous 30 days;
• Evidence of severe or uncontrolled systemic disease or any other significant disorders, which in the opinion of the investigator does not allow the participation in the study or could compromise the results

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Labomar SPA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Studio Pediatrico Dr. Gaetano Bottaro

Gravina di Catania, Catania, Italy

Countries

Italy

Other Identifiers

YOV/042022

Identifier Type: -

Identifier Source: org_study_id