Safety and Tolerability of the Gut Bacterium Phascolarctobacterium faecium DSM 32890

Background/Objectives: The prevalence of the commensal gut bacterium species, Phascolarctobacterium faecium, has been associated with normal weight in humans. Preclinical evidence suggests that the strain P. faecium DSM 32890 exerts beneficial effects on metabolic and immune function in diet-induced...

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Autores: Tamayo M, Tolosa-Enguis V, Alabadi B, Olivares M, Romera S, Orti L, Terrado E, Flor Duro A, Morillas C, Codoñer P, Real JT, Sanz Y
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2026
País:España
Institución:INCLIVA
Repositorio:r-INCLIVA. Repositorio Institucional de Producción Científica de INCLIVA
OAI Identifier:oai:incliva.fundanetsuite.com:p20751
Acceso en línea:https://incliva.portalinvestigacion.com/publicaciones/20751
Access Level:acceso abierto
Palabra clave:<italic>Phascolarctobacterium faecium</italic>
safety and tolerability
gut microbiome
obesity
type 2 diabetes
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spelling Safety and Tolerability of the Gut Bacterium Phascolarctobacterium faecium DSM 32890Tamayo MTolosa-Enguis VAlabadi BOlivares MRomera SOrti LTerrado EFlor Duro AMorillas CCodoñer PReal JTSanz Y<italic>Phascolarctobacterium faecium</italic>safety and tolerabilitygut microbiomeobesitytype 2 diabetesBackground/Objectives: The prevalence of the commensal gut bacterium species, Phascolarctobacterium faecium, has been associated with normal weight in humans. Preclinical evidence suggests that the strain P. faecium DSM 32890 exerts beneficial effects on metabolic and immune function in diet-induced obesity. Herein, we aimed to evaluate the safety and tolerability of this strain in a preclinical study and a pilot interventional trial in humans. Methods: A repeated-dose oral toxicity study of 28 days was performed in Wistar rats (male and female), during which adverse signs and clinical outcomes were assessed, along with histological, hematologic, biochemical, and immune markers. Subsequently, a pilot human intervention trial was conducted, including 20 participants (11 overweight and 9 normal weight) who received P. faecium DSM 32890 daily for 15 days. Body composition, dietary intake, physical activity, clinical data, perceived health, gastrointestinal symptoms, and blood analyses were assessed to determine tolerability and identify potential adverse effects. Results: In rats, the administration of the bacterium did not cause behavioral, physiological, histologic, immune, or biochemical alterations. In humans, there was no evidence of adverse effects on general health, hematological and biochemical profiles, bowel habits, or gastrointestinal symptoms. Overweight participants experienced reductions in flatulence and nausea after the intervention. Conclusions: The consumption of P. faecium DSM 32890 did not raise safety concerns and was well tolerated in rats and humans. The findings represent a step forward in the path toward future, longer-term studies to explore the potential efficacy.MDPI2026info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttps://incliva.portalinvestigacion.com/publicaciones/20751NutrientsISSN: 20726643reponame:r-INCLIVA. Repositorio Institucional de Producción Científica de INCLIVAinstname:INCLIVAInglésinfo:eu-repo/semantics/openAccessoai:incliva.fundanetsuite.com:p207512026-06-07T16:35:31Z
dc.title.none.fl_str_mv Safety and Tolerability of the Gut Bacterium Phascolarctobacterium faecium DSM 32890
title Safety and Tolerability of the Gut Bacterium Phascolarctobacterium faecium DSM 32890
spellingShingle Safety and Tolerability of the Gut Bacterium Phascolarctobacterium faecium DSM 32890
Tamayo M
<italic>Phascolarctobacterium faecium</italic>
safety and tolerability
gut microbiome
obesity
type 2 diabetes
title_short Safety and Tolerability of the Gut Bacterium Phascolarctobacterium faecium DSM 32890
title_full Safety and Tolerability of the Gut Bacterium Phascolarctobacterium faecium DSM 32890
title_fullStr Safety and Tolerability of the Gut Bacterium Phascolarctobacterium faecium DSM 32890
title_full_unstemmed Safety and Tolerability of the Gut Bacterium Phascolarctobacterium faecium DSM 32890
title_sort Safety and Tolerability of the Gut Bacterium Phascolarctobacterium faecium DSM 32890
dc.creator.none.fl_str_mv Tamayo M
Tolosa-Enguis V
Alabadi B
Olivares M
Romera S
Orti L
Terrado E
Flor Duro A
Morillas C
Codoñer P
Real JT
Sanz Y
author Tamayo M
author_facet Tamayo M
Tolosa-Enguis V
Alabadi B
Olivares M
Romera S
Orti L
Terrado E
Flor Duro A
Morillas C
Codoñer P
Real JT
Sanz Y
author_role author
author2 Tolosa-Enguis V
Alabadi B
Olivares M
Romera S
Orti L
Terrado E
Flor Duro A
Morillas C
Codoñer P
Real JT
Sanz Y
author2_role author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv <italic>Phascolarctobacterium faecium</italic>
safety and tolerability
gut microbiome
obesity
type 2 diabetes
topic <italic>Phascolarctobacterium faecium</italic>
safety and tolerability
gut microbiome
obesity
type 2 diabetes
description Background/Objectives: The prevalence of the commensal gut bacterium species, Phascolarctobacterium faecium, has been associated with normal weight in humans. Preclinical evidence suggests that the strain P. faecium DSM 32890 exerts beneficial effects on metabolic and immune function in diet-induced obesity. Herein, we aimed to evaluate the safety and tolerability of this strain in a preclinical study and a pilot interventional trial in humans. Methods: A repeated-dose oral toxicity study of 28 days was performed in Wistar rats (male and female), during which adverse signs and clinical outcomes were assessed, along with histological, hematologic, biochemical, and immune markers. Subsequently, a pilot human intervention trial was conducted, including 20 participants (11 overweight and 9 normal weight) who received P. faecium DSM 32890 daily for 15 days. Body composition, dietary intake, physical activity, clinical data, perceived health, gastrointestinal symptoms, and blood analyses were assessed to determine tolerability and identify potential adverse effects. Results: In rats, the administration of the bacterium did not cause behavioral, physiological, histologic, immune, or biochemical alterations. In humans, there was no evidence of adverse effects on general health, hematological and biochemical profiles, bowel habits, or gastrointestinal symptoms. Overweight participants experienced reductions in flatulence and nausea after the intervention. Conclusions: The consumption of P. faecium DSM 32890 did not raise safety concerns and was well tolerated in rats and humans. The findings represent a step forward in the path toward future, longer-term studies to explore the potential efficacy.
publishDate 2026
dc.date.none.fl_str_mv 2026
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://incliva.portalinvestigacion.com/publicaciones/20751
url https://incliva.portalinvestigacion.com/publicaciones/20751
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv MDPI
publisher.none.fl_str_mv MDPI
dc.source.none.fl_str_mv Nutrients
ISSN: 20726643
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instname:INCLIVA
instname_str INCLIVA
reponame_str r-INCLIVA. Repositorio Institucional de Producción Científica de INCLIVA
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