Clinical trial NCT00922727: Safety of Lactobacillus Reuteri (L. Reuteri) in Healthy Adults
Official title: Phase I Safety and Tolerance of Lactobacillus Reuteri in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Colic
Gastrointestinal Tract Infections
Keywords: L. reuteri
Cytokines
Toll like receptors
Healthy Adults
Probiotics
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2009-06-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 for a total of 60 doses. The effects on fecal bacteria, circulating white blood cell receptors and inflammatory cytokine profiles will be measured.

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-intestinal (GI) tract micro flora and prevention and treatment of mild diarrhea associated with GI-tract infections. The oil drops contain a dietary supplement of Lactobacillus reuteri DSM 17938. The patients will receive 5 drops (10\^8 live organisms) by mouth daily for 60 days. Daily administration will include 5 drops (5x10\^8) of L. reuteri or placebo daily for two months. During this time,circulating peripheral blood mononuclear cell (PBMC) toll-like receptor-2 and -4 levels will be measured, along with PBMC cytokine production levels in vitro. Fecal DGGE analysis(with sequencing of bacterial rDNA) will be completed identifying changes in fecal microbiota. Inflammation in the gut will also be assessed by fecal calprotectin assay (ELISA). The time on study treatment is 2 months, with 4 months observation, for a total of 6 months. There will be 7 required visits, during which, we will assess safety and immune system effects.

Eligibility criteria: Inclusion Criteria:

* Healthy Adults (18 - 60 years old)
* No other recognized illness

Exclusion Criteria:

* 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

Primary outcomes:
measure: Treatment of adults with probiotic (health-promoting bacteria) LR, will be safe and well-tolerated.
timeFrame: 8/1/2009 - 7/1/2009
Secondary outcomes:
measure: Determine if LR treatment affects circulating levels of pro-inflammatory and anti-inflammatory cytokines, along with expression levels of toll like receptors (TLRs)-2 and -4 in circulating peripheral blood mononuclear cells.
timeFrame: 4/1/2009-7/1/2009
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: J. Marc Rhoads, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mangalat N, Liu Y, Fatheree NY, Ferris MJ, Van Arsdall MR, Chen Z, Rahbar MH, Gleason WA, Norori J, Tran DQ, Rhoads JM. Safety and tolerability of Lactobacillus reuteri DSM 17938 and effects on biomarkers in healthy adults: results from a randomized masked trial. PLoS One. 2012;7(9):e43910. doi: 10.1371/journal.pone.0043910. Epub 2012 Sep 6.