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...
Saved in:
| Main Authors: | , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
MDPI AG
2024-12-01
|
| Series: | Microorganisms |
| Subjects: | |
| Online Access: | https://www.mdpi.com/2076-2607/12/12/2584 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1850238823519223808 |
|---|---|
| author | Gissel García Josanne Soto Antonio Díaz Jesús Barreto Carmen Soto Ana Beatriz Pérez Suselys Boffill Ángela Gutiérrez Raúl de Jesús Cano |
| author_facet | Gissel García Josanne Soto Antonio Díaz Jesús Barreto Carmen Soto Ana Beatriz Pérez Suselys Boffill Ángela Gutiérrez Raúl de Jesús Cano |
| author_sort | Gissel García |
| collection | DOAJ |
| description | (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. |
| format | Article |
| id | doaj-art-2dbe250aca2746d0bd3fb4c7a1ac2ff3 |
| institution | OA Journals |
| issn | 2076-2607 |
| language | English |
| publishDate | 2024-12-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Microorganisms |
| spelling | doaj-art-2dbe250aca2746d0bd3fb4c7a1ac2ff32025-08-20T02:01:20ZengMDPI AGMicroorganisms2076-26072024-12-011212258410.3390/microorganisms12122584Clinical and In Vitro Safety of <i>Heyndrickxia coagulans</i> AO 1167B: A Double-Blind, Placebo-Controlled TrialGissel García0Josanne Soto1Antonio Díaz2Jesús Barreto3Carmen Soto4Ana Beatriz Pérez5Suselys Boffill6Ángela Gutiérrez7Raúl de Jesús Cano8Pathology Department, Clinical Hospital “Hermanos Ameijeiras”, Calle San Lázaro No 701, Esq. a Belascoaín, La Habana 10400, CubaClinical Laboratory Department, Clinical Hospital “Hermanos Ameijeiras”, Calle San Lázaro No 701, Esq. a Belascoaín, La Habana 10400, CubaStatistical Department, Clinical Hospital “Hermanos Ameijeiras”, Calle San Lázaro No 701, Esq. a Belascoaín, La Habana 10400, CubaNutrition Department, Clinical Hospital “Hermanos Ameijeiras”, Calle San Lázaro No 701, Esq. a Belascoaín, La Habana 10400, CubaBiochemistry Department, Biology Faculty, Havana University Cuba, Calle 25 Esquina J Vedado, La Habana 10200, CubaCellular Immunology Laboratory, Virology Department, Tropical Medicine Institute “Pedro Kourí”, Autopista Novia del Medio Día Km 6 ½, La Habana 11400, CubaNutrition Department, Clinical Hospital “Hermanos Ameijeiras”, Calle San Lázaro No 701, Esq. a Belascoaín, La Habana 10400, CubaStatistical Department, Clinical Hospital “Hermanos Ameijeiras”, Calle San Lázaro No 701, Esq. a Belascoaín, La Habana 10400, CubaBiological Sciences Department, California Polytechnic State University, San Luis Obispo, CA 93407, USA(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.https://www.mdpi.com/2076-2607/12/12/2584safetyprobiotichumansrandomizedHeyndrickxia coagulansclinical trial |
| spellingShingle | Gissel García Josanne Soto Antonio Díaz Jesús Barreto Carmen Soto Ana Beatriz Pérez Suselys Boffill Ángela Gutiérrez Raúl de Jesús Cano Clinical and In Vitro Safety of <i>Heyndrickxia coagulans</i> AO 1167B: A Double-Blind, Placebo-Controlled Trial Microorganisms safety probiotic humans randomized Heyndrickxia coagulans clinical trial |
| title | Clinical and In Vitro Safety of <i>Heyndrickxia coagulans</i> AO 1167B: A Double-Blind, Placebo-Controlled Trial |
| title_full | Clinical and In Vitro Safety of <i>Heyndrickxia coagulans</i> AO 1167B: A Double-Blind, Placebo-Controlled Trial |
| title_fullStr | Clinical and In Vitro Safety of <i>Heyndrickxia coagulans</i> AO 1167B: A Double-Blind, Placebo-Controlled Trial |
| title_full_unstemmed | Clinical and In Vitro Safety of <i>Heyndrickxia coagulans</i> AO 1167B: A Double-Blind, Placebo-Controlled Trial |
| title_short | Clinical and In Vitro Safety of <i>Heyndrickxia coagulans</i> AO 1167B: A Double-Blind, Placebo-Controlled Trial |
| title_sort | clinical and in vitro safety of i heyndrickxia coagulans i ao 1167b a double blind placebo controlled trial |
| topic | safety probiotic humans randomized Heyndrickxia coagulans clinical trial |
| url | https://www.mdpi.com/2076-2607/12/12/2584 |
| work_keys_str_mv | AT gisselgarcia clinicalandinvitrosafetyofiheyndrickxiacoagulansiao1167badoubleblindplacebocontrolledtrial AT josannesoto clinicalandinvitrosafetyofiheyndrickxiacoagulansiao1167badoubleblindplacebocontrolledtrial AT antoniodiaz clinicalandinvitrosafetyofiheyndrickxiacoagulansiao1167badoubleblindplacebocontrolledtrial AT jesusbarreto clinicalandinvitrosafetyofiheyndrickxiacoagulansiao1167badoubleblindplacebocontrolledtrial AT carmensoto clinicalandinvitrosafetyofiheyndrickxiacoagulansiao1167badoubleblindplacebocontrolledtrial AT anabeatrizperez clinicalandinvitrosafetyofiheyndrickxiacoagulansiao1167badoubleblindplacebocontrolledtrial AT suselysboffill clinicalandinvitrosafetyofiheyndrickxiacoagulansiao1167badoubleblindplacebocontrolledtrial AT angelagutierrez clinicalandinvitrosafetyofiheyndrickxiacoagulansiao1167badoubleblindplacebocontrolledtrial AT rauldejesuscano clinicalandinvitrosafetyofiheyndrickxiacoagulansiao1167badoubleblindplacebocontrolledtrial |