CTRI/2010/091/000339
Completed
Phase 1
Probiotics for infectious diarrhea in children in south India
Christian Medical College Vellore0 sites160 target enrollmentTBD
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- Infectious Gastroenteritis
- Sponsor
- Christian Medical College Vellore
- Enrollment
- 160
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
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
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.
Outcomes
Primary Outcomes
Not specified
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