None listed
Conditions
Interventions
1. Active Product: Description Lactobacillus reuteri 17938 suspended in sunflower oil, medium chain triglyceride oil, silicone dioxide. Total viable count of L. reuteri 17938 1 x 108 CFU/5 drops p
Sponsors
ASOCIACION BENEFICA PRISMA,
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Have a parental permission form signed by both parents • Be between 8 weeks to 24 months of age with no preexisting exclusion criteria • Have parents who are willing to comply with all planned study procedures and be available for planned study visits for 3 months.
Exclusion criteria
Exclusion criteria: The following risk factors are at the level of the individual child: 2) Allergy to penicillin, cephalosporins, clindamycin or gentamicin 3) History of antibiotic use in the last 30 days 4) Use of probiotic products within the past 30 days, including masato (local product with fermenting bacteria) and yogurt products containing live bacterial cultures. 5) History of diarrheal illness within the past 30 days (See definition in Protocol Appendix B) 6) Presence of fever or a pre-existing adverse event monitored in the study (See Protocol Appendix B Definitions of AEs for specific adverse events monitored in the study) 7) Positive results on serum diagnostic tests for antibodies to HIV. 8) Presence of severe anemia, defined as serum hemoglobin < 7 gm/dL 9) Out of range laboratory values for total leucocyte count, BUN, Creatinine, AST, ALT, and total bilirubin monitored as potential adverse events, as described in Appendix E. 10) Pre-enrollment stool sample (collected within 14 days of day 1 of the study) is positive for L. reuteri by PCR.
Countries
Peru
Contacts
Public ContactMaribel Paredes
ASOCIACION BENEFICA PRISMA
Outcome results
None listed