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 @ 5:10 PM
Ignite Modification Date:
2025-12-24 @ 5:10 PM
NCT ID:
NCT02989350
Eligibility Criteria:
Inclusion Criteria:
1. Acute gastroenteritis (AGE) defined as a change in stool consistency to loose or liquid form (according to the Bristol Stool Form (BSF) scale or in the case of infants, the Amsterdam Stool Form (ASF) scale) and/or an increase in the frequency of evacuations (typically ≥3 in 24 h), lasting for no longer than 5 days.
2. Age: older than 1 month and younger than 60 months.
3. A caregiver must provide written informed consent.
Exclusion Criteria:
1. Use of antibiotics within two weeks prior to enrolment.
2. Use of gelatine tannate, diosmectite, probiotics, racecadotril, or zinc (including zinc containing ORS) within a week prior to enrolment (a single dose is allowed).
3. Breast feeding (\>50%)
4. Chronic diarrhoeal gastrointestinal disease (e.g., inflammatory bowel disease, cystic fibrosis, coeliac disease, food allergy)
5. Immunodeficiency
6. Malnutrition (weight/height/length under 3rd percentile) (WHO Child Growth Standards will be used)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Months
Maximum Age:
60 Months
Study:
NCT02989350
Study Brief:
Protocol Section:
NCT02989350