NCT05738746

The Efficacy of Pasteurised Akkermansia Muciniphila in Healthy Medical Workers

The Effects of the Anti-inflammatory Microbe - Pasteurized Akkermansia Muciniphila (PAM) on Symptoms of Somatic and Mental Stress in Healthcare Professionals

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 202 (actual)
• Sponsor: Pomeranian Medical University Szczecin · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

Gut microbiota alterations secondary to chronic stress might serve as a triggering factor towards manifestation of somatic and mental symptoms. The administration of pasteurised A. muciniphila MucT has the capability of supporting microbiota and improving the gut barrier integrity, which might lead to decrease of inflammation and the negative health consequences of stress in healthy participants.

Detailed description

The Gut-brain-microbiota axis (GBMA) is a bi-directional pathway, both neuronal and biochemical, between the intestine and the Central Nervous System (CNS). The gut microbiota plays a central role in gut-brain communication. The composition of intestinal microbiota and its functions play an important role in the pathogenesis of disorders of gut-brain interaction - both within the digestive tract and in the brain. Modulation of gut microbiota with the aid of probiotics, antibiotics, or germ-free feeding protocols significantly altered stressful event-induced behavioral outcomes in rodents. Moreover, the intake of various probiotics significantly improved stress-induced anxiety and depressive-like behaviors in mice. In humans, probiotics were also documented to display some beneficial effects on mental health, including alteration of emotional bias in healthy individuals, and alleviating stress and anxiety among stressed adults. Psychobiotics are imposed with certain limitations related to their standardization and end-shelf-life product stability. Therefore, the use of postbiotics, which contain bacterial metabolites or other bacteria derived fragments are viewed as novel solutions and alternatives to use of standard probiotics. One of novel postbiotics of interest among scientists and clinicians is pasteurized Akkermansia muciniphila MucT (PAM). Animal studies indicate that administration of Akkermansia muciniphila can ameliorate metabolic syndrome, obesity, diabetes, and inflammatory bowel disease in animals and has psychobiotic potential. Similar to live A. muciniphila, PAM could ameliorate several diseases as well. The mechanism of action of PAM - improving gut barrier integrity - suggests the potential use to reduce the negative effects of stress. Human studies shown that PAM is safety, what was confirmed in the Scientific Opinion of EFSA. Recently A. muciniphila was approved as the Novel Food. A proof of concept study will be conducted to verify the hypothesis that PAM reduces the psychological and somatic effects of stress.

Conditions

• Stress
• Healthy
• Dietary Supplement

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Pasteurized Akkermansia muciniphila	PAM supplementation; packaging will be given to the subjects every one month during follow-up visits, with the instructions to take one dose every morning on an empty stomach
DIETARY_SUPPLEMENT	Placebo	PBO administration; packaging will be given to the subjects every one month during follow-up visits, with the instructions to take one dose every morning on an empty stomach

Timeline

• Start date: 2023-10-24
• Primary completion: 2025-03-10
• Completion: 2025-03-10
• First posted: 2023-02-22
• Last updated: 2025-03-18

Locations

2 sites across 1 country: Poland