Safety of Lactobacillus Reuteri in Healthy Children Ages 2 to 5 Years in Peru

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02124122
• Date of registration: 24/04/2014
• Prospective Registration: Yes
• Primary sponsor: Tulane University School of Medicine
• Public title: Safety of Lactobacillus Reuteri in Healthy Children Ages 2 to 5 Years in Peru
• Scientific title: Safety of Lactobacillus Reuteri in Healthy Children Ages 2 to 5 Years in Peru
• Date of first enrolment: March 2015
• Target sample size: 60
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02124122
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 1

Countries of recruitment

Peru

Contacts

• Name: Margaret N Kosek, MD
• Affiliation: Johns Hopkins Bloomberg School of Public Health

• Name: Richard A Oberhelman, MD
• Affiliation: Tulane School of Public Health and Tropical Medicine

Key inclusion & exclusion 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.



Age minimum: 2 Years
Age maximum: 5 Years
Gender: All

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

Biological: Placebo

Biological: Lactobacillus reuteri

Primary Outcome(s)

Number of Participants With Positive Blood Culture for L Reuteri [Time Frame: Participants are followed an average of 36 days]

Mean Daily Temperature [Time Frame: Study days 1-5, 8,12, 15, 18, 28, and 36]

Secondary ID(s)

5U01AT002733

FDA IND# 13710-Protocol 2

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Asociación Benéfica Prisma

Johns Hopkins Bloomberg School of Public Health

National Center for Complementary and Integrative Health (NCCIH)

Results

• Results available: Yes
• Date Posted: 24/04/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02124122