Safety of Lactobacillus Reuteri in Healthy Volunteers (NCT00774163) | Clinical Trial Compass
CompletedPhase 1
Safety of Lactobacillus Reuteri in Healthy Volunteers
Peru45 participantsStarted 2010-02
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants With a Positive Blood Culture for L. Reuteri
Timeframe: participants were followed for an average of 36 days
2
Mean Daily Temperature
Timeframe: 5 days of study product administration
3
Leukocyte Count on Day 5
Timeframe: Measured on day 5
4
Serum Alanine Aminotransferase (ALT) in Female Participants