NCT00922727

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 15, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 17, 2009

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2009

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

January 25, 2018

Status Verified

January 1, 2018

Enrollment Period

1.7 years

First QC Date

June 15, 2009

Last Update Submit

January 23, 2018

Conditions

ColicGastrointestinal Tract Infections

Keywords

L. reuteriCytokinesToll like receptorsHealthy AdultsProbiotics

Outcome Measures

Primary Outcomes (1)

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

    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.

    4/1/2009-7/1/2009

Study Arms (2)

L. reuteri

ACTIVE COMPARATOR

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 microflora and prevention and treatment of mild diarrhea associated with GI-tract infections, travel or antibiotic treatment. The oil drops contain a dietary supplement of Lactobacillus reuteri DSM 17938.

Biological: L. reuteri

Sunflower Oil

PLACEBO COMPARATOR

Placebo will be the equivalent number of drops of suspended sunflower oil (without LR), provided by Biogaia.

Biological: Sunflower Oil

Interventions

L. reuteriBIOLOGICAL

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.

Also known as: BioGaia Drops
L. reuteri
Sunflower OilBIOLOGICAL

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.

Also known as: Placebo
Sunflower Oil

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Related 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 masked trial. PLoS One. 2012;7(9):e43910. doi: 10.1371/journal.pone.0043910. Epub 2012 Sep 6.

    PMID: 22970150RESULT

MeSH Terms

Conditions

Colic

Interventions

Sunflower Oil

Condition Hierarchy (Ancestors)

Infant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Plant OilsPlant PreparationsBiological ProductsComplex Mixtures

Study Officials

  • J. Marc Rhoads, M.D.

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Pediatric Gastroenterology

Study Record Dates

First Submitted

June 15, 2009

First Posted

June 17, 2009

Study Start

October 1, 2009

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

January 25, 2018

Record last verified: 2018-01

Locations

US(1)