Safety of Lactobacillus Reuteri in Healthy Children Ages 2 to 5 Years in Peru
Condition: Healthy
Intervention: Lactobacillus reuteri; Placebo
Intervention description: Probiotic; Placebo
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 60.0
Sex: All
Minimum age: 2 Years
Maximum age: 5 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Focus; safety

Summary:

      This is a Phase 1 study to assess the safety and tolerability of Lactobacillus reuteri (Lr)
      strain DSM 17938 in healthy children in Peru. It is a preliminary study in support of a
      clinical trial to assess safety and efficacy of L. reuteri for treatment of pediatric
      diarrhea in Peru.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children ages 2-5 years with no exclusion criteria

        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. Pregnancy or current breastfeeding by any household member

               3. Presence of an infant under age 6 months living in the household

               4. Presence of immune suppressed individuals or use of immunosuppressive agents
                  (including but not limited to corticosteroids and methotrexate, etc.) by any
                  household member

               5. 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

                  2) Allergy to penicillin or cephalosporins or gentamicin 3) History of antibiotic
                  use in the last 30 days 4) Use of probiotic products within the past 90 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 6) Presence of fever or a
                  pre-existing adverse event monitored in the study 7) Positive results on serum
                  diagnostic tests for antibodies to HIV.

                  Testing for Hepatitis B core antigen, and Hepatitis C is not necessary in
                  children as in adults, since there is universal vaccination for Hepatitis B among
                  children in this community, and both forms of hepatitis are rare and largely
                  asymptomatic in this age group.

                  8) Presence of severe anemia, defined as serum hemoglobin < 8 gm/dL

                  9) Out of range laboratory values for tests monitored as potential adverse
                  events, as described in Appendix 2, B. LABORATORY VALUES, and detected based on
                  Day 0 blood test results. However, subjects will only be excluded based on serum
                  hemoglobin if they meet exclusion criterion 8.

                  10) Pre-enrollment stool sample (collected within 14 days of Day 1 of the study)
                  is positive for L. reuteri by PCR.