Safety of Lactobacillus Reuteri (L. Reuteri) in Healthy Adults
Completed · Phase 1 · Has a placebo group
Conditions studied: Colic, Gastrointestinal Tract Infections
In brief
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 for a total of 60 doses. The effects on fecal bacteria, circulating white blood cell receptors and inflammatory cytokine profiles will be measured.
Key facts
- Study ID
- NCT00922727
- Run by
- The University of Texas Health Science Center, Houston
- People needed
- 40
- Starts
- 2009-10-01
- Expected to finish
- 2011-07-01
- Last updated by the study team
- 2018-01-25
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Healthy Adults (18 - 60 years old)
- No other recognized illness
You may not qualify if…
- 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
Where it is running
- University of Texas Health Science Center at Houston — Houston, Texas, United States
Full record on ClinicalTrials.gov
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