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| Name | Class |
|---|---|
| SANPROBI SPOLKA Z OGRANICZONA ODPOWIEDZIALNOSCIA SPOLKA KOMANDYTOWA | UNKNOWN |
| THE AKKERMANSIA COMPANY | UNKNOWN |
| Charite University, Berlin, Germany | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pasteurized Akkermansia muciniphila | Experimental | pasteurized A.muciniphila (Pasteurized, 3x10^10 bacteria per day) as supplement for 3 months, |
|
| Placebo | Placebo Comparator | placebo administered for 3 months once a day |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pasteurized Akkermansia muciniphila | Dietary Supplement | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Stress intensity | serum dehydroepiandrosterone sulfate (DHEAS) in blood | baseline |
| Stress intensity | serum dehydroepiandrosterone sulfate (DHEAS) in blood | 1 month |
| Stress intensity | serum dehydroepiandrosterone sulfate (DHEAS) in blood | 3 months |
| Cardiovascular marker of stressor intensity | blood pressure | baseline |
| Cardiovascular marker of stressor intensity | blood pressure | 1 month |
| Cardiovascular marker of stressor intensity | blood pressure | 3 months |
| Cardiovascular marker of stressor intensity | heart rate | baseline |
| Cardiovascular marker of stressor intensity | heart rate | 1 month |
| Cardiovascular marker of stressor intensity | heart rate |
| Measure | Description | Time Frame |
|---|---|---|
| Microbiota composition | next generation sequencing | baseline |
| Microbiota composition | next generation sequencing | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pomeranian Medical University in Szczecin | Szczecin | West Pomeranian Voivodeship | 70-210 | Poland | ||
| Center fo Medical Simulation |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31263284 | Background | Depommier C, Everard A, Druart C, Plovier H, Van Hul M, Vieira-Silva S, Falony G, Raes J, Maiter D, Delzenne NM, de Barsy M, Loumaye A, Hermans MP, Thissen JP, de Vos WM, Cani PD. Supplementation with Akkermansia muciniphila in overweight and obese human volunteers: a proof-of-concept exploratory study. Nat Med. 2019 Jul;25(7):1096-1103. doi: 10.1038/s41591-019-0495-2. Epub 2019 Jul 1. | |
| 26563823 |
| Label | URL |
|---|---|
| EC official website with research results | View source |
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| MAX DELBRUECK CENTRUM FUER MOLEKULARE MEDIZIN IN DER HELMHOLTZ-GEMEINSCHAFT (MDC) - MDC |
| UNKNOWN |
| Imperial College London | OTHER |
parallel-groups, randomized, placebo-controlled clinical study
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Sequentially numbered drug containers of identical appearance
|
| Placebo | Dietary Supplement | 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 |
|
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| 3 months |
| Stress intensity | Perceived Stress Scale (PSS-10). Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress. | baseline |
| Stress intensity | Perceived Stress Scale (PSS-10). Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress. | 1 month |
| Stress intensity | Perceived Stress Scale (PSS-10). Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress. | 3 months |
| Psychosocial working conditions | Copenhagen Psychosocial Questionnaire (COPSOQ). The scales of the COPSOQ are formed by adding the points of the individual questions of the scales by giving equal weights to each question. In most cases the questions have five response options. In these cases the weights are: 0, 25, 50, 75, and 100. The scale value is calculated as the simple average | baseline |
| Psychosocial working conditions | Copenhagen Psychosocial Questionnaire (COPSOQ). The scales of the COPSOQ are formed by adding the points of the individual questions of the scales by giving equal weights to each question. In most cases the questions have five response options. In these cases the weights are: 0, 25, 50, 75, and 100. The scale value is calculated as the simple average | 1 month |
| Psychosocial working conditions | Copenhagen Psychosocial Questionnaire (COPSOQ). The scales of the COPSOQ are formed by adding the points of the individual questions of the scales by giving equal weights to each question. In most cases the questions have five response options. In these cases the weights are: 0, 25, 50, 75, and 100. The scale value is calculated as the simple average | 3 months |
| The recognition of the most common mental disorders | Primary Care Evaluation of Mental Disorders (PRIME-MD). The yes/no questionnaire serves as an initial screen for 5 general groups of mental disorders commonly found in the general population | baseline |
| The recognition of the most common mental disorders | Primary Care Evaluation of Mental Disorders (PRIME-MD). The yes/no questionnaire serves as an initial screen for 5 general groups of mental disorders commonly found in the general population | 1 month |
| The recognition of the most common mental disorders | Primary Care Evaluation of Mental Disorders (PRIME-MD). The yes/no questionnaire serves as an initial screen for 5 general groups of mental disorders commonly found in the general population | 3 months |
| Depression | Patient Health Questionnaire-9 (PHQ-9). Nine items, each of which is scored 0 to 3, providing a 0 to 27 severity score.This score can then be referred to the accompanying PHQ-9 Scoring Box to interpret the TOTAL score. | baseline |
| Depression | Patient Health Questionnaire-9 (PHQ-9). Nine items, each of which is scored 0 to 3, providing a 0 to 27 severity score.This score can then be referred to the accompanying PHQ-9 Scoring Box to interpret the TOTAL score. | 1 month |
| Depression | Patient Health Questionnaire-9 (PHQ-9). Nine items, each of which is scored 0 to 3, providing a 0 to 27 severity score.This score can then be referred to the accompanying PHQ-9 Scoring Box to interpret the TOTAL score. | 3 months |
| Depressive state | The Beck Depression Inventory (BDI). When the test is scored, a value of 0 to 3 is assigned for each answer and then the total score is compared to a key to determine the depression's severity. The standard cut-off scores were as follows: 0-18: indicates minimal depression 18-30: indicates mild depression 19-29: indicates moderate depression 30-63: indicates severe depression. | baseline |
| Depressive state | The Beck Depression Inventory (BDI). When the test is scored, a value of 0 to 3 is assigned for each answer and then the total score is compared to a key to determine the depression's severity. The standard cut-off scores were as follows: 0-18: indicates minimal depression 18-30: indicates mild depression 19-29: indicates moderate depression 30-63: indicates severe depression. | 1 month |
| Depressive state | The Beck Depression Inventory (BDI). When the test is scored, a value of 0 to 3 is assigned for each answer and then the total score is compared to a key to determine the depression's severity. The standard cut-off scores were as follows: 0-18: indicates minimal depression 18-30: indicates mild depression 19-29: indicates moderate depression 30-63: indicates severe depression. | 3 months |
| Anxiety and stress | Depression Anxiety Stress Scale 21 (DASS-21). This is a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress. The rating scale is as follows: 0 - Did not apply to me at all
SUBSCALES: DASS_Anxiety = questions 2 + 4 + 7 + 9 + 15 + 19 + 20 DASS_Depression = questions 3 + 5 + 10 + 13 + 16 + 17 + 21 DASS_Stress = questions 1 + 6 + 8 + 11 + 12 + 14 +18 | baseline |
| Anxiety and stress | Depression Anxiety Stress Scale 21 (DASS-21). This is a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress. The rating scale is as follows: 0 - Did not apply to me at all
SUBSCALES: DASS_Anxiety = questions 2 + 4 + 7 + 9 + 15 + 19 + 20 DASS_Depression = questions 3 + 5 + 10 + 13 + 16 + 17 + 21 DASS_Stress = questions 1 + 6 + 8 + 11 + 12 + 14 +18 | 1 month |
| Anxiety and stress | Depression Anxiety Stress Scale 21 (DASS-21). This is a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress. The rating scale is as follows: 0 - Did not apply to me at all
SUBSCALES: DASS_Anxiety = questions 2 + 4 + 7 + 9 + 15 + 19 + 20 DASS_Depression = questions 3 + 5 + 10 + 13 + 16 + 17 + 21 DASS_Stress = questions 1 + 6 + 8 + 11 + 12 + 14 +18 | 3 months |
| Occurrence of Irritable Bowel Syndrome | Rome IV criteria | baseline |
| Occurrence of Irritable Bowel Syndrome | Rome IV criteria | 1 month |
| Occurrence of Irritable Bowel Syndrome | Rome IV criteria | 3 months |
| Occurence and severity of gastrointestinal symptoms | Gastrointestinal Symptom Rating Scale (GSRS) | baseline |
| Occurence and severity of gastrointestinal symptoms | Gastrointestinal Symptom Rating Scale (GSRS) | 1 month |
| Occurence and severity of gastrointestinal symptoms | Gastrointestinal Symptom Rating Scale (GSRS) | 3 months |
| Microbiota composition | next generation sequencing | 3 months |
| A. muciniphila count in stool | real-time quantitative PCR (qPCR) | baseline |
| A. muciniphila count in stool | real-time quantitative PCR (qPCR) | 1 month |
| A. muciniphila count in stool | real-time quantitative PCR (qPCR) | 3 months |
| Total bacteria count in stool | real-time quantitative PCR (qPCR) | baseline |
| Total bacteria count in stool | real-time quantitative PCR (qPCR) | 1 month |
| Total bacteria count in stool | real-time quantitative PCR (qPCR) | 3 months |
| Short chain fatty acids content in stool | quadrupole mass spectrometer and high performance liquid chromatograph | baseline |
| Short chain fatty acids content in stool | quadrupole mass spectrometer and high performance liquid chromatograph | 1 month |
| Short chain fatty acids content in stool | quadrupole mass spectrometer and high performance liquid chromatograph | 3 months |
| Immune phenotypes of peripheral blood mononuclear cells (PBMCs) | single-cell genomics (scRNA-seq and scATAC-seq) analyses (in blood) | baseline |
| Immune phenotypes of peripheral blood mononuclear cells (PBMCs) | single-cell genomics (scRNA-seq and scATAC-seq) analyses (in blood) | 1 month |
| Immune phenotypes of peripheral blood mononuclear cells (PBMCs) | single-cell genomics (scRNA-seq and scATAC-seq) analyses (in blood) | 3 months |
| Inflammatory mediators concentrations in blood | high-throughput protein biomarker analysis with the advent of Proximity Extension Assay | baseline |
| Inflammatory mediators concentrations in blood | high-throughput protein biomarker analysis with the advent of Proximity Extension Assay | 1 month |
| Inflammatory mediators concentrations in blood | high-throughput protein biomarker analysis with the advent of Proximity Extension Assay | 3 months |
| Zonulin concentration in stool | enzyme-linked immunosorbent assay (ELISA) | baseline |
| Zonulin concentration in stool | enzyme-linked immunosorbent assay (ELISA) | 1 month |
| Zonulin concentration in stool | enzyme-linked immunosorbent assay (ELISA) | 3 months |
| Calprotectin concentration in stool | enzyme-linked immunosorbent assay (ELISA) | baseline |
| Calprotectin concentration in stool | enzyme-linked immunosorbent assay (ELISA) | 1 month |
| Calprotectin concentration in stool | enzyme-linked immunosorbent assay (ELISA) | 3 months |
| Lipopolysaccharide concentration in blood | enzyme-linked immunosorbent assay (ELISA) | baseline |
| Lipopolysaccharide concentration in blood | enzyme-linked immunosorbent assay (ELISA) | 1 month |
| Lipopolysaccharide concentration in blood | enzyme-linked immunosorbent assay (ELISA) | 3 months |
| Adiposity | Fat mass/fat free mass evaluated by bioimpedance | baseline |
| Adiposity | Fat mass/fat free mass evaluated by bioimpedance | 1 month |
| Adiposity | Fat mass/fat free mass evaluated by bioimpedance | 3 months |
| Obesity | Body weight | baseline |
| Obesity | Body weight | 1 month |
| Obesity | Body weight | 3 months |
| Dietary habits | the frequency of certain food consumption (rank score) by means of validated Food Frequency Questionnaire (FFQ). | baseline |
| Physical activity | International Physical Activity Questionnaire. Results can be reported in categories (low activity levels, moderate activity levels or high activity levels) or as a continuous variable (MET minutes a week). | baseline |
| Functions of peripheral blood mononuclear cells (PBMCs) | mass cytometry (CyTOF) | baseline |
| Functions of peripheral blood mononuclear cells (PBMCs) | mass cytometry (CyTOF) | 1 month |
| Functions of peripheral blood mononuclear cells (PBMCs) | mass cytometry (CyTOF) | 3 months |
| Insulin resistance | HOMA-Homeostasis Model Assessment calculated from fasted glycemia and insulinemia | baseline |
| Insulin resistance | HOMA-Homeostasis Model Assessment calculated from fasted glycemia and insulinemia | 1 month |
| Insulin resistance | HOMA-Homeostasis Model Assessment calculated from fasted glycemia and insulinemia | 3 months |
| carbohydrate metabolism | glycated hemoglobin (HbA1c) | baseline |
| carbohydrate metabolism | glycated hemoglobin (HbA1c) | 1 month |
| carbohydrate metabolism | glycated hemoglobin (HbA1c) | 3 months |
| Concentration of blood lipids | Analysis of circulating lipids : total, LDL and HDL cholesterol (mg/dl), triglycerides (md/dl) | baseline |
| Concentration of blood lipids | Analysis of circulating lipids : total, LDL and HDL cholesterol (mg/dl), triglycerides (md/dl) | 1 month |
| Concentration of blood lipids | Analysis of circulating lipids : total, LDL and HDL cholesterol (mg/dl), triglycerides (md/dl) | 3 months |
| Szczecin |
| West Pomeranian Voivodeship |
| 71-240 |
| Poland |
| Background |
| Schneeberger M, Everard A, Gomez-Valades AG, Matamoros S, Ramirez S, Delzenne NM, Gomis R, Claret M, Cani PD. Akkermansia muciniphila inversely correlates with the onset of inflammation, altered adipose tissue metabolism and metabolic disorders during obesity in mice. Sci Rep. 2015 Nov 13;5:16643. doi: 10.1038/srep16643. |
| 32725676 | Background | Druart C, Plovier H, Van Hul M, Brient A, Phipps KR, de Vos WM, Cani PD. Toxicological safety evaluation of pasteurized Akkermansia muciniphila. J Appl Toxicol. 2021 Feb;41(2):276-290. doi: 10.1002/jat.4044. Epub 2020 Jul 28. |
| 35641786 | Background | Cani PD, Depommier C, Derrien M, Everard A, de Vos WM. Akkermansia muciniphila: paradigm for next-generation beneficial microorganisms. Nat Rev Gastroenterol Hepatol. 2022 Oct;19(10):625-637. doi: 10.1038/s41575-022-00631-9. Epub 2022 May 31. |