Status:
COMPLETED
Safety of Lactobacillus Reuteri (L. Reuteri) in Healthy Adults
Lead Sponsor:
The University of Texas Health Science Center, Houston
Collaborating Sponsors:
National Center for Complementary and Integrative Health (NCCIH)
Conditions:
Colic
Gastrointestinal Tract Infections
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
This study will evaluate the safety and tolerability of the probiotic Lactobacillus reuteri (LR) in healthy adult patients. Patients will be randomized to receive either LR or placebo orally each day ...
Detailed Description
Lactobacillus reuteri oil drops are a natural product containing Lactobacillus reuteri (LR), which has traditionally been used for the establishment and maintenance of a well-functioning gastro-intest...
Eligibility Criteria
Inclusion
- Healthy Adults (18 - 60 years old)
- No other recognized illness
Exclusion
- Pregnancy or breastfeeding
- Patient taking immunosuppressive medications, including oral corticosteroids
- Positive result of HIV, Hepatitis B, and/or Hepatitis C test
- Abnormal lab test results
- Gastrointestinal related diseases and surgeries
- Patients with an allergy to antibiotics
- Presence of fever or a pre-existing adverse event monitored in the study
- No more than two study participants in one household
- Use of probiotics in the last 90 days
- Diarrheal illness within the past 30 days
- Recent or current use of oral antibiotics /anti-fungals(in the past 2 weeks)
- Current use of oral laxatives
- Chronic alcohol use or more than 1 drink per day
- Subjects with implanted prosthetic devices including prosthetic heart valves
- Known sensitivity to sunflower oil or products containing linolenic/oleic acids
- Will require that subject not take any other probiotic-containing products, including yogurt supplemented with probiotics during the 6-month period
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00922727
Start Date
October 1 2009
End Date
July 1 2011
Last Update
January 25 2018
Active Locations (1)
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1
University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030