Safety of Lactobacillus Reuteri in Healthy Volunteers
Recruitment status was Active, not recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Biological: Lactobacillus reuteri Other: Placebo |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | Phase 1: Safety of Lactobacillus Reuteri in Healthy Volunteers |
- To assess association between administration of Lactobacillus reuteri (Lr) strain DSM 17938 and abnormal lab values (CBC, BUN, Creatinine, AST, ALT, blood culture). [ Time Frame: end of study ] [ Designated as safety issue: Yes ]
- To evaluate the duration of shedding of Lactobacillus reuteri (Lr) strain DSM 17938 following administration. [ Time Frame: end of study ] [ Designated as safety issue: No ]
- To assess the clinical tolerance of Lactobacillus reuteri (Lr) strain DSM 17938 following administration, based on presence of physical symptoms and adverse events. [ Time Frame: end of study ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 45 |
| Study Start Date: | February 2010 |
| Estimated Study Completion Date: | October 2010 |
| Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period
|
Biological: Lactobacillus reuteri
Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period
Other Name: BioGaia Probiotic Drops
|
|
Placebo Comparator: 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
|
Other: Placebo
5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period
|
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).
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Adults 18-65 with no 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).
Exclusion Criteria:
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.
Contacts and Locations| Peru | |
| Community of Santa Clara | |
| Iquitos, Loreto, Peru | |
| 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, MD, Tulane Unversity School of Public Health and Tropical Medicine |
| ClinicalTrials.gov Identifier: | NCT00774163 History of Changes |
| Other Study ID Numbers: | FDA IND# 13710, 1R01AT002733-01A1 |
| Study First Received: | October 15, 2008 |
| Last Updated: | July 22, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Tulane University School of Medicine:
|
probiotics lactobacillus reuteri none (safety only) |
ClinicalTrials.gov processed this record on May 21, 2013