None listed
Conditions
Interventions
Group 1 Type of group
Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period
Group name:Group 2 Type of group
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
Sponsors
ASOCIACION BENEFICA PRISMA,
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:To assess association between administration of Lactobacillus reuteri (Lr) strain DSM 17938 and abnormal lab values (CBC, BUN, Creatinine, AST, ALT, blood culture). Measure:Number of Participants With a Positive Blood Culture for L. Reuteri Timepoints:participants were followed for an average of 36 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Measured daily during 5 days of study product administration Measure:Mean Daily Temperature Timepoints:5 days of study product administration ; Outcome name:Laboratory tests performed during the study. Measure:Changes in Leukocyte Count on Day 5, Serum Alanine Aminotransferase (ALT), Serum ALT in Males, Serum Aspartate Aminotransferase (AST) in Females, Serum AST in Males, Blood Urea Nitrogen, Serum Creatinine Timepoints:Day 5 | — |
Countries
Peru
Contacts
Public ContactMargaret Kosek
ASOCIACION BENEFICA PRISMA
Outcome results
None listed