Phase 1
Completed N=45
Safety of Lactobacillus Reuteri in Healthy Volunteers
Healthy
Source: ClinicalTrials.gov NCT00774163 ↗
Enrolled (actual)
45
Serious AEs
0.0%
Results posted
Jul 2013
Primary outcomePrimary: Number of Participants With a Positive Blood Culture for L. Reuteri — 0; 0 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With a Positive Blood Culture for L. Reuteri |
0; 0 | — |
| PRIMARY Mean Daily Temperature |
36.02; 36.04 | — |
| PRIMARY Leukocyte Count on Day 5 |
6936; 7893 | — |
| PRIMARY Serum Alanine Aminotransferase (ALT) in Female Participants |
30.3; 22.2 | — |
| PRIMARY Serum ALT in Males |
31.1; 27.8 | — |
| PRIMARY Serum Aspartate Aminotransferase (AST) in Females |
28.3; 22.4 | — |
| PRIMARY Serum AST in Males |
31; 31 | — |
| PRIMARY Blood Urea Nitrogen |
22.4; 19.3 | — |
| PRIMARY Serum Creatinine |
0.73; 0.73 | — |
| SECONDARY Number of Subjects With at Least One PCR Positive Stool Specimen |
9; 5 | — |
| SECONDARY Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Vomiting Reported |
4; 3 | — |
| SECONDARY Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Pruritis Reported |
1; 12 | — |
| SECONDARY Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Headache Reported |
67; 32 | — |
| SECONDARY Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Malaise Reported |
13; 19 | — |
| SECONDARY Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Diarrhea Reported |
18; 5 | — |
| SECONDARY Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Myalgia Reported |
41; 15 | — |
| SECONDARY Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Subjective Fever Reported |
15; 2 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00774163). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.