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

Colic Clinical Trial

Official title:

Phase I Safety and Tolerance of Lactobacillus Reuteri in Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00922727
• Other study ID #: HS-MSC-08-0266
• Secondary ID: R21AT003519-01A2
• Status: Completed
• Phase: Phase 1
• First received: June 15, 2009
• Last updated: January 23, 2018
• Start date: October 2009
• Est. completion date: July 2011

Study information

• Verified date: January 2018
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Colic
• Gastrointestinal Tract Infections

Intervention

Biological:
• L. reuteri
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.
• Sunflower Oil
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.

Locations

Country	Name	City	State
United States	University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 maske — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment of adults with probiotic (health-promoting bacteria) LR, will be safe and well-tolerated.		8/1/2009 - 7/1/2009
Secondary	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.		4/1/2009-7/1/2009