Safety of Lactobacillus Reuteri in Healthy Volunteers

Healthy Clinical Trial

Official title:

Phase 1: Safety of Lactobacillus Reuteri in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00774163
• Other study ID #: FDA IND# 13710
• Secondary ID: 1R01AT002733-01A
• Status: Completed
• Phase: Phase 1
• First received: October 15, 2008
• Last updated: December 15, 2016
• Start date: February 2010
• Est. completion date: October 2010

Study information

• Verified date: December 2016
• Source: Tulane University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

This is a phase I blinded randomized study of the safety and tolerability of Lactobacillus reuteri DSM 17938 given daily for a period of five consecutive days. Upon enrollment subjects will be randomized to one of two treatment groups in a ratio of treatment to placebo of 2:1. Subjects will be randomized to receive either:

A. Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period that corresponds to a dose of the closely related L. reuteri ATCC 55730 strain that has shown to be therapeutic for infantile colic. The strain used in this study (DSM 17938) has been cured of an antibiotic resistance plasmid found in the original BioGaia strain (L. reuteri ATCC 55730).

B. 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 (BioGaia AB, Stockholm, Sweden).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: October 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Adults 18-65 with no exclusion criteria

• 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).

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

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

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

Locations

Country	Name	City	State
Peru	Community of Santa Clara	Iquitos	Loreto

Sponsors (4)

Lead Sponsor	Collaborator
Tulane University School of Medicine	Asociación Benéfica Prisma, Johns Hopkins Bloomberg School of Public Health, National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

Peru, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	Mean Daily Temperature	Measured daily during 5 days of study product administration	5 days of study product administration	Yes
Primary	Leukocyte Count on Day 5		Measured on day 5	Yes
Primary	Serum Alanine Aminotransferase (ALT) in Female Participants		Day 5	Yes
Primary	Serum ALT in Males		Day 5	Yes
Primary	Serum Aspartate Aminotransferase (AST) in Females		Day 5	Yes
Primary	Serum AST in Males		Day 5	Yes
Primary	Blood Urea Nitrogen		Day 5	Yes
Primary	Serum Creatinine		Day 5	Yes
Secondary	Number of Subjects With at Least One PCR Positive Stool Specimen		Average of 36 day follow up period	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Diarrhea Reported		Day 0 through 6 weeks after Day 0	No
Secondary	Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Myalgia Reported		Day 0 through 6 weeks after Day 0	No
Secondary	Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Subjective Fever Reported		Day 0 through 6 weeks after Day 0	No