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:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2025-12-24 @ 6:59 PM
NCT ID:
NCT03988257
Eligibility Criteria:
Inclusion Criteria:
* Children aged 13-120 months, hospitalized or requiring a visit in the emergency department (ED) or outpatient consultation due to AGE, defined as a decrease in the stool consistency (grade 6 or 7 in Bristol Stool Form Scale) and/or an increase in the frequency of stool evacuations \> 3 in 24 hours.
* Duration of symptoms 24-72 hours at the time of inclusion.
* Caretaker's written, informed consent.
Exclusion Criteria:
* Duration of symptoms \> 72 hours at the time of inclusion.
* Co-occurring other systemic infectious diseases (ex. pneumonia, sepsis).
* Diagnosed immune deficiency.
* Malnutrition (defined as the body mass index (BMI) \<-2 SDS (Standard Deviation Scores) or \< 3rd percentile based on the World Health Organization (WHO) percentile charts.
* Chronic diarrhoeal gastrointestinal disease (inflammatory bowel disease, short bowel syndrome, cystic fibrosis, celiac disease, food allergy).
* Use of antibiotics, probiotics, prebiotics or anti-diarrhea (Diosmectite, Racecadotril) medicines within 7 days prior to enrolment into the study.
* Use of probiotics, Diosmectite, Racecadotril during the current AGE episode.
* Use of pleuran in the 14 days prior to enrolment into the study.
* Parallel involvement of the patient in other clinical trials, with the exception of observational studies.
* No legal caregivers' consent to participate in the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
13 Months
Maximum Age:
120 Months
Study:
NCT03988257
Study Brief:
Protocol Section:
NCT03988257