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 @ 3:57 PM
Ignite Modification Date:
2025-12-24 @ 3:57 PM
NCT ID:
NCT01130792
Eligibility Criteria:
Inclusion Criteria:
* Male and female children aged 6 months to 5 years
* Diagnosis of rotaviral or cryptosporidial gastroenteritis (Rotavirus or
* Cryptosporidium EIA positive and three or more watery stools within a 24-hour period)
* No other enteric pathogen isolated from the stool at the time of enrollment
* Able to take the contents of study capsules mixed into food or milk
* No need for antibiotics for current illness
* No use of LGG/other probiotics within 30 days (yogurt consumption is not an exclusion criterion)
* HIV negative
* No severe malnutrition (WAZ score \< 3SD below the median)
* No evidence of active bowel leak, acute abdomen or colitis
* No history of allergy
* Parent/guardian willing to report on compliance and side effects during the study period
* Families willing to provide informed consent, participate in study and have study personnel visit their home.
Exclusion criteria
* Other enteric pathogens isolated from the stool at the time of enrollment
* Not willing or able to take the contents of study capsules mixed into food or milk
* Need for antibiotics for current illness
* HIV positive
* Severe malnutrition (WAZ score \< 3SD below the median)
* Presence of active bowel leak, acute abdomen or colitis
* History of allergy
* Parent/guardian not willing to report on compliance and side effects during the study period
* Families not willing to provide informed consent, participate in study or have study personnel visit their home.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
5 Years
Study:
NCT01130792
Study Brief:
Protocol Section:
NCT01130792