Safety of Lactobacillus Reuteri in Healthy Volunteers

NCT00774163 | Completed Phase 1 Results

• 2 other identifiers: FDA IND# 137101R01AT002733-01A1
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase one study to assess the safety of daily dosing of Lactobacillus reuteri in healthy adults in Peru. It is conducted as a preliminary study in support of a clinical trial to assess safety and efficacy of Lactobacillus reuteri versus placebo for treatment of pediatric diarrhea in Peru.

Conditions

Healthy

Keywords

probiotics; lactobacillus; reuteri; none (safety only)

Outcome Measures

Primary Outcomes (9)

• Number of Participants With a Positive Blood Culture for L. Reuteri

  To assess association between administration of Lactobacillus reuteri (Lr) strain DSM 17938 and abnormal lab values (CBC, BUN, Creatinine, AST, ALT, blood culture).

  participants were followed for an average of 36 days

• Mean Daily Temperature

  Measured daily during 5 days of study product administration

  5 days of study product administration

• Leukocyte Count on Day 5

  Measured on day 5

• Serum Alanine Aminotransferase (ALT) in Female Participants

  Day 5

• Serum ALT in Males

  Day 5

• Serum Aspartate Aminotransferase (AST) in Females

  Day 5

• Serum AST in Males

  Day 5

• Blood Urea Nitrogen

  Day 5

• Serum Creatinine

  Day 5

Secondary Outcomes (8)

• Number of Subjects With at Least One PCR Positive Stool Specimen

  Average of 36 day follow up period

• Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Vomiting Reported

  Day 0 through 6 weeks after Day 0

• Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Pruritis Reported

  Day 0 through 6 weeks after Day 0

• Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Headache Reported

  Day 0 through 6 weeks after Day 0

• Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Malaise Reported

  Day 0 through 6 weeks after Day 0

Study Arms (2)

1

EXPERIMENTAL

Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period

Biological: Lactobacillus reuteri

2

PLACEBO COMPARATOR

Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period

Other: Placebo

Interventions

Lactobacillus reuteri BIOLOGICAL

Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period

Also known as: BioGaia Probiotic Drops

1

Placebo OTHER

5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Subject is a male or, if the subject is female and of childbearing potential then she must have a negative serum or urine pregnancy test result within 48 hours of initiating study preparations and agree to use an acceptable method of contraception. Acceptable methods of contraception include depot forms of progesterone containing therapies or an intrauterine device (IUD).
• No enrollment of family members in households where any of the following are present:
• Another study participant in the household
• Pregnancy or current breastfeeding by any household member
• Presence of an infant under age 6 months living in the household
• Presence of immune suppressed individuals or use of immunosuppressive agents (corticosteroids, methotrexate) by any household member
• Presence of a serious congenital anomaly or chronic medical condition that would contraindicate participation in any household member, including history of gastrointestinal surgery, chronic gastrointestinal illness, abnormal intestinal anatomy, or abnormal bowel functionality
• Allergy to penicillin or cephalosporins
• History of antibiotic use in the last 30 days
• Use of probiotic products within the past 90 days
• History of diarrheal illness within the past 30 days
• Presence of fever or a pre-existing adverse event monitored in the study
• Positive results on serum diagnostic tests for antibodies to HIV, Hepatitis B core antigen, and Hepatitis C.

Sponsors & Collaborators

• Tulane University School of Medicine: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator
• Johns Hopkins Bloomberg School of Public Health: collaborator
• Asociacion Benefica Prisma: collaborator

Study Sites (1)

Community of Santa Clara

Iquitos, Loreto, Peru

Location

Results Point of Contact

• Title: Dr. Richard Oberhelman
• Organization: Tulane University School of Public Health and Tropical Medicine

oberhel@tulane.edu

504-988-2511

Study Officials

• Richard A Oberhelman, MD

  Tulane School of Public Health and Tropical Medicine

  PRINCIPAL INVESTIGATOR

• Margaret N Kosek, MD

  Johns Hopkins Bloomberg School of Public Health

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 15, 2008
• First Posted: October 17, 2008
• Study Start: February 1, 2010
• Primary Completion: June 1, 2010
• Study Completion: October 1, 2010
• Last Updated: December 19, 2016
• Results First Posted: July 12, 2013

Record last verified: 2016-12

Locations

PE (1)