Ignite Creation Date:
2024-05-06 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05738746
Status:
RECRUITING
Last Update Posted:
2023-11-08
First Post:
2023-01-30
Brief Title:
The Efficacy of Pasteurised Akkermansia Muciniphila in Healthy Medical Workers
Sponsor:
Pomeranian Medical University Szczecin
Organization:
Pomeranian Medical University Szczecin
Study Overview
Official Title:
The Effects of the Anti-inflammatory Microbe - Pasteurized Akkermansia Muciniphila PAM on Symptoms of Somatic and Mental Stress in Healthcare Professionals
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MENTAkHEALTH
Brief 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None