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Completed

NCT Number: NCT00922727

Safety of Lactobacillus Reuteri (L. Reuteri) in Healthy Adults

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.

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Key information

Conditions

Colic Congenital, Hereditary, and Neonatal Diseases and Abnormalities Gastrointestinal Tract Infections Infant, Newborn, Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

L. reuteri

Biological

The oil drops contains 10^8 CFU (colony forming units). As suggested by the manufacturer in the Certificate of Analysis the daily dose given to each patient will be 5 x 10^8 CFU/ 5 drops. The dose given is within the release limit which is greater than 2 x 10^8 CFU/ 5 drops and less than 8 x 10^8 CFU/ 5 drops.

Other names: BioGaia Drops

Sunflower Oil

Biological

As suggested by the manufacturer in the Certificate of Analysis the daily dose given to each patient will be 5 x 10^8 CFU/ 5 drops.

Other names: Placebo

Primary outcomes

  1. Treatment of adults with probiotic (health-promoting bacteria) LR, will be safe and well-tolerated.

    Time frame: 8/1/2009 - 7/1/2009

Secondary outcomes

  1. 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.

    Time frame: 4/1/2009-7/1/2009

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

Phase I Safety and Tolerance of Lactobacillus Reuteri in Adults

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jun 17, 2009
Registry last updated
Jan 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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