The Efficacy of Pasteurised Akkermansia Muciniphila in Healthy Medical Workers (MENTAkHEALTH)

Pomeranian Medical University Szczecin

Status: Completed

Conditions: Healthy; Dietary Supplement; Stress

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Pasteurized Akkermansia muciniphila

Study type: Interventional

Funder types: Other

Identifiers

NCT05738746

101095540

Details and patient eligibility

About

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.

Full 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.

Enrollment: 202 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Working in a high stress hospital department, like: emergency, trauma, intensive care, surgery, internal diseases;
• Written informed consent to participate in this study before any study-mandated procedure;
• Body mass index (BMI) ≥18.5 kg/m2 and ≤ 35 kg/m2;
• A willingness and motivation to follow the study protocol.

Exclusion criteria

• Diagnosis of autoimmune, neurological, immunocompromised, thyroid, inflammatory bowel diseases, irritable bowel syndrome, diabetes, cancer, and/or IgE-dependent allergy;
• Psychiatric comorbidities, including mental retardation, organic brain dysfunction, or addiction (except nicotine and caffeine), intake of antipsychotic and antidepressive drugs;
• Proton pump inhibitors usage;
• The use of antibiotics and/or probiotics 4 weeks prior to the study;
• Glucocorticosteroids and/or metformin treatment;
• Dietary supplementation (except for vitamin D) within the three months before screening;
• Specific restrictive (e.g. elimination, vegan, FODMAP, reduction) diet within the three months before screening;
• Significant changes in physical activity 4 weeks before the trial entry;
• Pregnancy or lactation;
• Significant GI surgery within the last 6 months prior to or planned during the study;
• Any other medication for management of IBS complaints like peppermint oil, bile acid binders;
• Lactose intolerance;
• Participation in another study during the last 30 days prior to and during the study;
• Any other reason for exclusion as per investigator's judgment, e.g. insufficient compliance with study procedures.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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202 participants in 2 patient groups, including a placebo group

Pasteurized Akkermansia muciniphila

Experimental group

Description:

pasteurized A.muciniphila (Pasteurized, 3x10\^10 bacteria per day) as supplement for 3 months,

Treatment:

Dietary Supplement: Pasteurized Akkermansia muciniphila

Placebo

Placebo Comparator group

Description:

placebo administered for 3 months once a day

Treatment:

Dietary Supplement: Placebo