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

Prospective Observational Study for the Evaluation of Probiotics Food Supplement in the Re-equilibration of the Intestinal Microbiota, in Paediatric Age

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

Study Overview

• Status: Completed
• Conditions: Diarrhea
• Intervention / Treatment: Dietary supplement: YOVIS BIMBI

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.

• Study Type: Observational
• Enrollment (Actual): 43

Contacts and Locations

Study Locations

• Italy
  • Catania
    • Gravina Di Catania, Catania, Italy, 95030
      • Studio Pediatrico Dr. Gaetano Bottaro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: N/A

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Labomar SPA

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2022
• Primary Completion (Actual): May 26, 2023
• Study Completion (Actual): January 30, 2024

Study Registration Dates

• First Submitted: April 19, 2024
• First Submitted That Met QC Criteria: May 3, 2024
• First Posted (Actual): May 7, 2024

Study Record Updates

• Last Update Posted (Actual): May 7, 2024
• Last Update Submitted That Met QC Criteria: May 3, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Diarrhea
• Other Study ID Numbers: YOV/042022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No