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

NCT02124122 | Completed Phase 1 Results DMC

• 2 other identifiers: FDA IND# 13710-Protocol 25U01AT002733
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Keywords

Focus; safety

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Positive Blood Culture for L Reuteri

  Participants are followed an average of 36 days

• Mean Daily Temperature

  Mean of body temperatures recorded on study days listed, averaged across all participants at all time points

  Study days 1-5, 8,12, 15, 18, 28, and 36

Study Arms (2)

Lactobacillus

EXPERIMENTAL

Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period that corresponds to a dose of the closely related L. reuteri ATCC 55730 strain that has shown to be therapeutic for infantile colic. The strain used in this study (DSM 17938) has been cured of an antibiotic resistance plasmid found in the original BioGaia strain (L. reuteri ATCC 55730).

Biological: Lactobacillus reuteri

Placebo

PLACEBO COMPARATOR

Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period (BioGaia AB, Stockholm, Sweden).

Biological: Placebo

Interventions

Lactobacillus reuteri BIOLOGICAL

Probiotic

Also known as: BioGaia Probiotic Drops

Lactobacillus

Placebo BIOLOGICAL

Placebo

Placebo

Eligibility Criteria

• Age: 2 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may not qualify if:

• \) No enrollment of family members in households where any of the following are present:
• Another study participant in the household
• Pregnancy or current breastfeeding by any household member
• Presence of an infant under age 6 months living in the household
• Presence of immune suppressed individuals or use of immunosuppressive agents (including but not limited to corticosteroids and 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
• \) 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.
• \) 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.
• \) Presence of severe anemia, defined as serum hemoglobin \< 8 gm/dL
• \) 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
• National Center for Complementary and Integrative Health (NCCIH): collaborator
• Johns Hopkins Bloomberg School of Public Health: collaborator
• Asociacion Benefica Prisma: collaborator

Study Sites (1)

Community of Santa Clara

Santa Clara, Loreto, Peru

Location

Related Publications (1)

• Kosek MN, Penataro-Yori P, Paredes-Olortegui M, Lefante J, Ramal-Asayag C, Zamora-Babilonia M, Meza-Sanchez G, Oberhelman RA. Safety of Lactobacillus Reuteri DSM 17938 in Healthy Children 2-5 Years of Age. Pediatr Infect Dis J. 2019 Aug;38(8):e178-e180. doi: 10.1097/INF.0000000000002267.

  PMID: 30531312 DERIVED

Results Point of Contact

• Title: Richard Oberhelman
• Organization: Tulane SPHTM

oberhel@tulane.edu

5049882511

Study Officials

• Richard A Oberhelman, MD

  Tulane School of Public Health and Tropical Medicine

  PRINCIPAL INVESTIGATOR

• Margaret N Kosek, MD

  Johns Hopkins Bloomberg School of Public Health

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: April 24, 2014
• First Posted: April 28, 2014
• Study Start: March 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: January 1, 2016
• Last Updated: April 24, 2017
• Results First Posted: April 24, 2017

Record last verified: 2017-03

Locations

PE (1)