Safety of Lactobacillus Reuteri in Healthy Children Aged 2-24 Months

NCT02460575 | Completed Phase 1 Results DMC

• 1 other identifier: U01DK105849
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Keywords

Safety

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Positive Blood Culture for L. Reuteri

  number of participants with positive blood culture for L. reuteri

  Participants are followed for an average of 36 days

• Mean Daily Temperature

  5 days of study product administration

Study Arms (2)

Lactobacillus

EXPERIMENTAL

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.

Biological: Lactobacillus reuteri 17938

Placebo

PLACEBO COMPARATOR

Composition Sunflower oil, medium chain triglyceride oil and silicon dioxide. Total viable count of L. reuteri is zero CFU/ 5 drops.

Biological: Placebo

Interventions

Lactobacillus reuteri 17938 BIOLOGICAL

probiotic

Lactobacillus

Placebo BIOLOGICAL

Composition Sunflower oil, medium chain triglyceride oil and silicon dioxide. Total viable count of L. reuteri is zero CFU/ 5 drops.

Placebo

Eligibility Criteria

• Age: 2 Months - 24 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Have parents who are willing to comply with all planned study procedures and be available for planned study visits for 3 months.
• \) 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.

Sponsors & Collaborators

• Tulane University School of Medicine: lead
• Johns Hopkins Bloomberg School of Public Health: collaborator
• Asociacion Benefica Prisma: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• University of Virginia: collaborator

Study Sites (1)

Centro de Salud de Santa Clara

Santa Clara, Loreto, Peru

Location

Results Point of Contact

• Title: Dr. Richard Oberhelman
• Organization: Tulane University

oberhel@tulane.edu

504-988-2511

Study Officials

• Margaret N Kosek, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 28, 2015
• First Posted: June 2, 2015
• Study Start: January 9, 2019
• Primary Completion: December 29, 2019
• Study Completion: December 29, 2019
• Last Updated: May 4, 2020
• Results First Posted: May 4, 2020

Record last verified: 2020-04

Locations

PE (1)