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 @ 5:56 PM
Ignite Modification Date:
2025-12-24 @ 5:56 PM
NCT ID:
NCT00370968
Eligibility Criteria:
Inclusion Criteria:
* Males
* Age 1 month up to 36 months:
* Passage of 3 or more liquid stools in a 24-hour period, every day, and at least one in 12 hours prior to admission
* Diarrhea for \< 7days (168 hours)
Exclusion Criteria:
* severe systemic illness requiring intensive care management; systemic infection will be suspected if there is a general appearance of non-wellbeing with one or more of the following symptoms: shrill cry and irritability, temperature instability, hypotension, hypoglycemia, altered sensorium, lethargy or refusal of feeds, abdominal distension.
* chronic illness like Tuberculosis, Nephrotic syndrome, malignancy etc or any surgical disorder.
* severe malnutrition (weight for age \<65% of NCHS median
* gross blood in stool
* refusal of consent
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
1 Month
Maximum Age:
36 Months
Study:
NCT00370968
Study Brief:
Protocol Section:
NCT00370968