Clinical and In Vitro Safety of <i>Heyndrickxia coagulans</i> AO 1167B: A Double-Blind, Placebo-Controlled Trial

Clinical and In Vitro Safety of <i>Heyndrickxia coagulans</i> AO 1167B: A Double-Blind, Placebo-Controlled Trial

(1) Background: <i>Heyndrickxia coagulans</i>, a lactic acid-producing bacterium, displays characteristics of both <i>Lactobacillus</i> and <i>Bacillus</i> genera. Clinical evidence suggests its potential health benefits. This study evaluated the safety of <i&g...

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Main Authors: Gissel García, Josanne Soto, Antonio Díaz, Jesús Barreto, Carmen Soto, Ana Beatriz Pérez, Suselys Boffill, Ángela Gutiérrez, Raúl de Jesús Cano
Format: Article
Language:English
Published: MDPI AG 2024-12-01
Series:Microorganisms
Subjects:
safety
probiotic
humans
randomized
Heyndrickxia coagulans
clinical trial
Online Access:https://www.mdpi.com/2076-2607/12/12/2584
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Summary:(1) Background: <i>Heyndrickxia coagulans</i>, a lactic acid-producing bacterium, displays characteristics of both <i>Lactobacillus</i> and <i>Bacillus</i> genera. Clinical evidence suggests its potential health benefits. This study evaluated the safety of <i>H. coagulans</i> AO1167B as a candidate probiotic supplement. (2) Methods: Strain identification was confirmed through morphological, cultural, and genomic analyses, including 16S RNA and whole genome sequencing to assess antimicrobial resistance and virulence factors. Phenotypic tests, such as disk diffusion for antimicrobial resistance, and safety assays for cytotoxicity and hemolytic activity, were conducted. In a phase I, double-blind, placebo-controlled clinical trial, healthy adults were randomized into <i>H. coagulans</i> AO1167B and placebo groups for 60 days. Daily capsule consumption was monitored through clinical and hematological evaluations, adverse event tracking, and health surveys. (3) Results: The genome of <i>H. coagulans</i> AO1167B revealed no concerning features. Disk diffusion tests showed no antimicrobial resistance. The strain exhibited no cytotoxic or hemolytic activity, indicating in vitro safety. No significant differences in clinical or hematological parameters were observed between groups. The most common adverse event, gas, diminished over time. (4) Conclusions: <i>H. coagulans</i> AO1167B demonstrates a suitable safety profile, genetic stability, and probiotic potential for gastrointestinal health, justifying further clinical research.
ISSN:2076-2607

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