Clinical trial NCT06403358: Study for Evaluation of Probiotics in the Re-equilibration of the Intestinal Microbiota, in Paediatric Age
Official title: Prospective Observational Study for the Evaluation of Probiotics Food Supplement in the Re-equilibration of the Intestinal Microbiota, in Paediatric Age
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diarrhea
Lead sponsor: Labomar SPA
Sponsor class: INDUSTRY
First posted: 2024-05-07
Enrollment: 43
Sex: ALL
Minimum age (years): 3
Maximum age (years): 14
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Evaluation of the efficacy of oral administration of probiotics food supplement in paediatric population with acute diarrhea
timeFrame: Baseline, during the intervention, immediately after the intervention
measure: Evaluation of the efficacy of oral administration of probiotics food supplement in paediatric population with acute diarrhea
timeFrame: Baseline, during the intervention, immediately after the intervention
Secondary outcomes:
measure: Evaluation of the safety profile of probiotics food supplement
timeFrame: Immediately after the intervention
measure: Evaluation of the safety profile of probiotics food supplement
timeFrame: During the intervention, immediately after the intervention
measure: Assessment of the compliance to the treatment
timeFrame: During the intervention, immediately after the intervention
measure: Analysis of the hydration state
timeFrame: BaselinaDuring the intervention, immediately after the intervention
Other outcomes:
Locations:
city: Gravina Di Catania
country: Italy
facility: Studio Pediatrico Dr. Gaetano Bottaro
state: Catania
Study officials:
References: