High-dose Probiotic Mix of <i>Lactobacillus</i> spp., <i>Bifidobacterium</i> spp., <i>Bacillus coagulans</i>, and <i>Saccharomyces boulardii</i> to Prevent Antibiotic-associated Diarrhea in Adults: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial (SPAADA).

ABSTRACT:

Background

Probiotics have been used to prevent antibiotic-associated diarrhea (AAD), but practical guidelines are sparse. This trial evaluated the efficacy and safety of a high-dose, multistrain probiotic mix (Sinquanon), specially designed for prevention of AAD in adults.

Methods

A phase IV, multicenter, randomized, double-blind, placebo-controlled, parallel-group clinical trial was conducted over 5 months. Participants receiving broad-spectrum antibiotics were administered the specialized probiotic mix or placebo from the first dose of antibiotics until 14 days after the last antibiotic dose. The primary outcome measure was the incidence of AAD.

Results

In total, 564 participants were randomized (probiotic mix: 285; placebo: 279), of which 9 participants discontinu

SUBMITTER: Hodzhev V 

PROVIDER: S-EPMC11551610 | biostudies-literature | 2024 Nov

REPOSITORIES: biostudies-literature