Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:06 AM
Ignite Modification Date:
2025-12-25 @ 12:06 AM
NCT ID:
NCT06403358
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
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
14 Years
Study:
NCT06403358
Study Brief:
Protocol Section:
NCT06403358