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

NCT06403358 | Completed

• 1 other identifier: YOV/042022
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

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

Conditions

Diarrhea

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (4)

• Evaluation of the safety profile of probiotics food supplement

  Immediately after the intervention

• Evaluation of the safety profile of probiotics food supplement

  During the intervention, immediately after the intervention

• Assessment of the compliance to the treatment

  During the intervention, immediately after the intervention

• Analysis of the hydration state

  BaselinaDuring the intervention, immediately after the intervention

Interventions

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.

Eligibility Criteria

• Age: 3 Years - 14 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Labomar SPA: lead

Study Sites (1)

Studio Pediatrico Dr. Gaetano Bottaro

Gravina di Catania, Catania, 95030, Italy

Location

MeSH Terms

Conditions

Diarrhea

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2024
• First Posted: May 7, 2024
• Study Start: November 28, 2022
• Primary Completion: May 26, 2023
• Study Completion: January 30, 2024
• Last Updated: May 7, 2024

Record last verified: 2024-05

Locations

IT (1)