Safety of Lactobacillus Reuteri in Healthy Children Aged 2-24 Months
Condition: Healthy
Intervention: Lactobacillus reuteri 17938; Placebo
Intervention description: probiotic; Composition Sunflower oil, medium chain triglyceride oil and silicon dioxide. Total viable count of L. reuteri is zero CFU/ 5 drops.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 60.0
Sex: All
Minimum age: 2 Months
Maximum age: 24 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Safety

Summary:

      Phase I double blinded randomized trial of the safety and tolerability of Lactobacillus
      reuteri DSM 17938 given for five successive days in healthy children. Sixty children will
      receive study product at a treatment to placebo ratio of 2:1 and followed for 3 months for
      safety outcomes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  In order to be eligible to participate in this study, a subject must meet all of the
             following 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:

          -  1) No enrollment of family members in households where any of the following are
             present:

               1. Another study participant in the household

               2. Presence of immune suppressed individuals or use of immunosuppressive agents
                  (including but not limited to corticosteroids, methotrexate, etc.) by any
                  household member

               3. Presence of a serious congenital anomaly or chronic medical condition that in the
                  opinion of the investigators would contraindicate participation in any household
                  member, including history of gastrointestinal surgery, chronic gastrointestinal
                  illness, abnormal intestinal anatomy, or abnormal bowel functionality

                  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.