Safety of Lactobacillus Reuteri in Healthy Volunteers

NCT ID: NCT00774163

Last Updated: 2016-12-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2010-10-31

Brief Summary

This is a phase one study to assess the safety of daily dosing of Lactobacillus reuteri in healthy adults in Peru. It is conducted as a preliminary study in support of a clinical trial to assess safety and efficacy of Lactobacillus reuteri versus placebo for treatment of pediatric diarrhea in Peru.

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).

Conditions

Healthy

Keywords

probiotics; lactobacillus; reuteri; none (safety only)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

1

Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period

Group Type: EXPERIMENTAL

Lactobacillus reuteri

Intervention Type: BIOLOGICAL

Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period

2

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period

Interventions

Lactobacillus reuteri

Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period

Intervention Type: BIOLOGICAL

Placebo

5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period

Intervention Type: OTHER

Other Intervention Names

BioGaia Probiotic Drops

Eligibility Criteria

Exclusion Criteria

• Subject is a male or, if the subject is female and of childbearing potential then she must have a negative serum or urine pregnancy test result within 48 hours of initiating study preparations and agree to use an acceptable method of contraception. Acceptable methods of contraception include depot forms of progesterone containing therapies or an intrauterine device (IUD).

• 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 (corticosteroids, methotrexate) by any household member
• Presence of a serious congenital anomaly or chronic medical condition that 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
• History of antibiotic use in the last 30 days
• Use of probiotic products within the past 90 days
• History of diarrheal illness within the past 30 days
• Presence of fever or a pre-existing adverse event monitored in the study
• Positive results on serum diagnostic tests for antibodies to HIV, Hepatitis B core antigen, and Hepatitis C.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

Johns Hopkins Bloomberg School of Public Health

OTHER

Sponsor Role: collaborator

Asociacion Benefica Prisma

OTHER

Sponsor Role: collaborator

Tulane University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Richard A. Oberhelman

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Richard A Oberhelman, MD

Role: PRINCIPAL_INVESTIGATOR

Tulane School of Public Health and Tropical Medicine

Margaret N Kosek, MD

Role: STUDY_DIRECTOR

Johns Hopkins Bloomberg School of Public Health

Locations

Community of Santa Clara

Iquitos, Loreto, Peru

Countries

Peru

Other Identifiers

1R01AT002733-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

FDA IND# 13710

Identifier Type: -

Identifier Source: org_study_id