Comparative phase I randomized open-label pilot clinical trial of Gynophilus^® (Lcr regenerans^®) immediate release capsules versus slow release muco-adhesive tablets.

ABSTRACT: Gynophilus^® (Lcr regenerans^®) is a live biotherapeutic product (LBP) that contains the live biotherapeutic microorganism Lactobacillus rhamnosus Lcr35^®, which is indicated to restore vaginal health. The aim of the study was to compare the safety, ease of use, and compliance of two formulations (immediate release: IR capsule and slow release: SR muco-adhesive tablets) as well as the colonization of Lcr35^® in healthy women. This phase I study (Comprigel) is a parallel, randomized, 4-arm, and open-label clinical trial evaluating an IR daily capsule formulation vs. a SR tablet administered every 3, 4, or 5 days for 21 days. Self-collected vaginal swabs were used to quantify Lcr35^® and characterize the composition and structure of the vagin

SUBMITTER: Dausset C 

PROVIDER: S-EPMC6154122 | biostudies-literature | 2018 Oct

REPOSITORIES: biostudies-literature