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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2014 by Tulane University School of Medicine
Sponsor:
Collaborators:
Johns Hopkins Bloomberg School of Public Health
Asociacion Benefica PRISMA
Information provided by (Responsible Party):
Richard A. Oberhelman, Tulane University School of Medicine
ClinicalTrials.gov Identifier:
NCT02124122
First received: April 24, 2014
Last updated: April 25, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Healthy
Biological: Lactobacillus reuteri
Biological: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Safety of Lactobacillus Reuteri in Healthy Children Ages 2 to 5 Years in Peru

Resource links provided by NLM:


Further study details as provided by Tulane University School of Medicine:

Primary Outcome Measures:
  • number of participants with positive blood culture for L reuteri [ Time Frame: Participants are followed an average of 36 days ] [ Designated as safety issue: Yes ]
  • Mean daily temperature [ Time Frame: 5 days of study product administration ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: April 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lactobacillus
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
Other Name: BioGaia Probiotic Drops
Placebo Comparator: Placebo
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

Detailed Description:

This is a phase I blinded randomized study of the safety and tolerability of Lactobacillus reuteri DSM 17938 given daily for a period of five consecutive days. Upon enrollment subjects will be randomized to one of two treatment groups in a ratio of treatment to placebo of 2:1. Subjects will be randomized to receive either:

A. 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).

B. 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).

In the first 30 subjects randomized, administration of each dose of the study preparation drops (A or B above) will be immediately followed by offering 2 ounces of flavored PediaSure ® (Abbott Laboratories) nutritional supplement to each child. The second 30 subjects enrolled will not be offered PediaSure ® after product administration. This format will also allow us to assess the impact of concurrent administration of a buffering non-lactose containing formula with prebiotic nutritional properties on intestinal colonization with L. reuteri by PCR.

  Eligibility

Ages Eligible for Study:   2 Years to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02124122

Contacts
Contact: Margaret N Kosek, MD 011-51-65-234250 mkosek@jhsph.edu
Contact: Pablo Yori, MS 011-51-65-234250 pyori@jhsph.edu

Locations
Peru
Community of Santa Clara Not yet recruiting
Santa Clara, Loreto, Peru
Principal Investigator: Margaret N Kosek, MD         
Sponsors and Collaborators
Tulane University School of Medicine
Johns Hopkins Bloomberg School of Public Health
Asociacion Benefica PRISMA
Investigators
Principal Investigator: Richard A Oberhelman, MD Tulane School of Public Health and Tropical Medicine
Study Director: Margaret N Kosek, MD Johns Hopkins School of Public Health
  More Information

No publications provided

Responsible Party: Richard A. Oberhelman, Professor, Tulane University School of Medicine
ClinicalTrials.gov Identifier: NCT02124122     History of Changes
Other Study ID Numbers: FDA IND# 13710-Protocol 2, U01AT002733
Study First Received: April 24, 2014
Last Updated: April 25, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Tulane University School of Medicine:
Focus
safety

ClinicalTrials.gov processed this record on July 20, 2014