Phase 1: Safety of Lactobacillus Reuteri in Healthy Volunteers

ASOCIACION BENEFICA PRISMA,0 个研究点目标入组 0 人开始时间: 2009年9月8日最近更新: 2023年9月4日

试验速览

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•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).

•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.

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