Status:
COMPLETED
Safety of Lactobacillus Reuteri in Healthy Volunteers
Lead Sponsor:
Tulane University School of Medicine
Collaborating Sponsors:
National Center for Complementary and Integrative Health (NCCIH)
Johns Hopkins Bloomberg School of Public Health
Conditions:
Healthy
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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 safet...
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 randomi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00774163
Start Date
February 1 2010
End Date
October 1 2010
Last Update
December 19 2016
Active Locations (1)
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1
Community of Santa Clara
Iquitos, Loreto, Peru