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 @ 3:47 AM
Ignite Modification Date:
2025-12-25 @ 3:47 AM
NCT ID:
NCT01814202
Eligibility Criteria:
Inclusion Criteria:
* males or females between 6 months and 5 years of age
* acute diarrhea (\<48 hours) without interfering co-morbidities
* guardian willing to have child admitted to hospital as an inpatient for 96 hours and to return to the clinic with the child on Day 7 for a final evaluation
* Guardian is willing and able to report to the Investigator information on stool frequency, stool consistency and food and water intakes during the follow up phase.
* Written informed consent must be obtained prior to admission to this study.
* The subject has a physical examination that reveals no clinically significant abnormalities other than those expected for subjects with acute infectious diarrhea.
Exclusion Criteria:
* Suspected or confirmed cholera
* Suspected dysentery
* Symptom duration \>48 hours at screening
* Vomiting severity that is like to make administration and retention of test article impossible
* Severe malnutrition (defined as weight for height of less than -3 SD below median, per WHO Standards (6).
* Child already receiving antibiotics or anti-motility drugs for this diarrhea episode prior to screening.
* History of hypersensitivity or allergy to milk or egg
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
5 Years
Study:
NCT01814202
Study Brief:
Protocol Section:
NCT01814202