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

Completed

• Conditions: Diarrhea

• Registration Number: NCT06403358
• Lead Sponsor: Labomar SPA

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.

Study Timeline

• Study Start: 2022-11-28
• Primary Completion: 2023-05-26
• Study Completion: 2024-01-30
• Study First Submitted: 2024-04-19
• Status Verified: 2024-05
• Study First Submitted QC: 2024-05-03
• Last Update Submitted: 2024-05-03
• Study First Posted: 2024-05-07
• Last Update Posted: 2024-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of the efficacy of oral administration of probiotics food supplement in paediatric population with acute diarrhea	Baseline, during the intervention, immediately after the intervention	Reduction of diarrhea duration.

Secondary Outcome Measures

Name	Time	Method
Evaluation of the safety profile of probiotics food supplement	During the intervention, immediately after the intervention	Evaluation of the eventual presence adverse event/serious adverse events.
Assessment of the compliance to the treatment	During the intervention, immediately after the intervention	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
Analysis of the hydration state	BaselinaDuring the intervention, immediately after the intervention	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;

Trial Locations

Locations (1)

Studio Pediatrico Dr. Gaetano Bottaro; 🇮🇹 Gravina Di Catania, Catania, Italy