Phase 1
Completed N=60
Safety of Lactobacillus Reuteri in Healthy Children Aged 2-24 Months
Healthy
Source: ClinicalTrials.gov NCT02460575 ↗
Enrolled (actual)
60
Serious AEs
0.0%
Results posted
May 2020
Primary outcomePrimary: Number of Participants With Positive Blood Culture for L. Reuteri — 0; 0 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Positive Blood Culture for L. Reuteri |
0; 0 | — |
| PRIMARY Mean Daily Temperature |
36.5; 36.5 | — |
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:
- Another study participant in the household
- Presence of immune suppressed individuals or use of immunosuppressive agents (including but not limited to corticosteroids, methotrexate, etc.) by any household member
- 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:
- 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.
- 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.
- Presence of severe anemia, defined as serum hemoglobin < 7 gm/dL
- 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.
- Pre-enrollment stool sample (collected within 14 days of day 1 of the study) is positive for L. reuteri by PCR.
Data sourced from ClinicalTrials.gov (NCT02460575). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.