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StressMENTAkHEALTHNCT05738746

The Efficacy of Pasteurised Akkermansia Muciniphila in Healthy Medical Workers

A study testing Pasteurized Akkermansia muciniphila in people with Stress and Healthy, run by Pomeranian Medical University Szczecin at 2 sites in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Stress, Healthy, Dietary Supplement
What is being tested?
Pasteurized Akkermansia muciniphila
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
202 participants
Where
2 sitesPoland
Study dates
24 Oct 2023to 10 Mar 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 14Show fewer
  • 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 locations and contacts

2 sites in 1 country.

Poland2 sites

  • Pomeranian Medical University in Szczecin

    Szczecin, West Pomeranian Voivodeship, 70-210

  • Center fo Medical Simulation

    Szczecin, West Pomeranian Voivodeship, 71-240

Other trials in Poland

About this study

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

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.

Read the 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.

Being tested
Pasteurized Akkermansia muciniphila, Placebo
Keywords
microbiota, postbiotic, stress, metabolome, immunometabolism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pasteurized Akkermansia muciniphilaDietary supplement

    Also called PAM

    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

  • PlaceboDietary supplement

    Also called PBO

    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

Study groups in NCT05738746
Study groupRoleWhat they receive
Pasteurized Akkermansia muciniphilaExperimentalpasteurized A.muciniphila (Pasteurized, 3x10^10 bacteria per day) as supplement for 3 months,
Receives: Dietary Supplement: Pasteurized Akkermansia muciniphila
PlaceboPlacebo comparatorplacebo administered for 3 months once a day
Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Stress intensity

    serum dehydroepiandrosterone sulfate (DHEAS) in blood

    Measured: baseline

  2. Stress intensity

    serum dehydroepiandrosterone sulfate (DHEAS) in blood

    Measured: 1 month

  3. Stress intensity

    serum dehydroepiandrosterone sulfate (DHEAS) in blood

    Measured: 3 months

  4. Cardiovascular marker of stressor intensity

    blood pressure

    Measured: baseline

  5. Cardiovascular marker of stressor intensity

    blood pressure

    Measured: 1 month

  6. Cardiovascular marker of stressor intensity

    blood pressure

    Measured: 3 months

  7. Cardiovascular marker of stressor intensity

    heart rate

    Measured: baseline

  8. Cardiovascular marker of stressor intensity

    heart rate

    Measured: 1 month

  9. Cardiovascular marker of stressor intensity

    heart rate

    Measured: 3 months

  10. 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.

    Measured: baseline

  11. 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.

    Measured: 1 month

  12. 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.

    Measured: 3 months

  13. 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

    Measured: baseline

  14. 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

    Measured: 1 month

  15. 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

    Measured: 3 months

  16. 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

    Measured: baseline

  17. 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

    Measured: 1 month

  18. 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

    Measured: 3 months

  19. 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.

    Measured: baseline

  20. 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.

    Measured: 1 month

  21. 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.

    Measured: 3 months

  22. 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.

    Measured: baseline

  23. 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.

    Measured: 1 month

  24. 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.

    Measured: 3 months

  25. 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

    1. - Applied to me to some degree, or some of the time
    2. - Applied to me to a considerable degree, or a good part of time
    3. - Applied to me very much, or most of the time.

    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

    Measured: baseline

  26. 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

    1. - Applied to me to some degree, or some of the time
    2. - Applied to me to a considerable degree, or a good part of time
    3. - Applied to me very much, or most of the time.

    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

    Measured: 1 month

  27. 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

    1. - Applied to me to some degree, or some of the time
    2. - Applied to me to a considerable degree, or a good part of time
    3. - Applied to me very much, or most of the time.

    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

    Measured: 3 months

  28. Occurrence of Irritable Bowel Syndrome

    Rome IV criteria

    Measured: baseline

  29. Occurrence of Irritable Bowel Syndrome

    Rome IV criteria

    Measured: 1 month

  30. Occurrence of Irritable Bowel Syndrome

    Rome IV criteria

    Measured: 3 months

  31. Occurence and severity of gastrointestinal symptoms

    Gastrointestinal Symptom Rating Scale (GSRS)

    Measured: baseline

  32. Occurence and severity of gastrointestinal symptoms

    Gastrointestinal Symptom Rating Scale (GSRS)

    Measured: 1 month

  33. Occurence and severity of gastrointestinal symptoms

    Gastrointestinal Symptom Rating Scale (GSRS)

    Measured: 3 months

Secondary outcomes (47)

  1. Microbiota composition

    next generation sequencing

    Measured: baseline

  2. Microbiota composition

    next generation sequencing

    Measured: 1 month

  3. Microbiota composition

    next generation sequencing

    Measured: 3 months

  4. A. muciniphila count in stool

    real-time quantitative PCR (qPCR)

    Measured: baseline

  5. A. muciniphila count in stool

    real-time quantitative PCR (qPCR)

    Measured: 1 month

  6. A. muciniphila count in stool

    real-time quantitative PCR (qPCR)

    Measured: 3 months

  7. Total bacteria count in stool

    real-time quantitative PCR (qPCR)

    Measured: baseline

  8. Total bacteria count in stool

    real-time quantitative PCR (qPCR)

    Measured: 1 month

  9. Total bacteria count in stool

    real-time quantitative PCR (qPCR)

    Measured: 3 months

  10. Short chain fatty acids content in stool

    quadrupole mass spectrometer and high performance liquid chromatograph

    Measured: baseline

  11. Short chain fatty acids content in stool

    quadrupole mass spectrometer and high performance liquid chromatograph

    Measured: 1 month

  12. Short chain fatty acids content in stool

    quadrupole mass spectrometer and high performance liquid chromatograph

    Measured: 3 months

  13. Immune phenotypes of peripheral blood mononuclear cells (PBMCs)

    single-cell genomics (scRNA-seq and scATAC-seq) analyses (in blood)

    Measured: baseline

  14. Immune phenotypes of peripheral blood mononuclear cells (PBMCs)

    single-cell genomics (scRNA-seq and scATAC-seq) analyses (in blood)

    Measured: 1 month

  15. Immune phenotypes of peripheral blood mononuclear cells (PBMCs)

    single-cell genomics (scRNA-seq and scATAC-seq) analyses (in blood)

    Measured: 3 months

  16. Inflammatory mediators concentrations in blood

    high-throughput protein biomarker analysis with the advent of Proximity Extension Assay

    Measured: baseline

  17. Inflammatory mediators concentrations in blood

    high-throughput protein biomarker analysis with the advent of Proximity Extension Assay

    Measured: 1 month

  18. Inflammatory mediators concentrations in blood

    high-throughput protein biomarker analysis with the advent of Proximity Extension Assay

    Measured: 3 months

  19. Zonulin concentration in stool

    enzyme-linked immunosorbent assay (ELISA)

    Measured: baseline

  20. Zonulin concentration in stool

    enzyme-linked immunosorbent assay (ELISA)

    Measured: 1 month

  21. Zonulin concentration in stool

    enzyme-linked immunosorbent assay (ELISA)

    Measured: 3 months

  22. Calprotectin concentration in stool

    enzyme-linked immunosorbent assay (ELISA)

    Measured: baseline

  23. Calprotectin concentration in stool

    enzyme-linked immunosorbent assay (ELISA)

    Measured: 1 month

  24. Calprotectin concentration in stool

    enzyme-linked immunosorbent assay (ELISA)

    Measured: 3 months

  25. Lipopolysaccharide concentration in blood

    enzyme-linked immunosorbent assay (ELISA)

    Measured: baseline

  26. Lipopolysaccharide concentration in blood

    enzyme-linked immunosorbent assay (ELISA)

    Measured: 1 month

  27. Lipopolysaccharide concentration in blood

    enzyme-linked immunosorbent assay (ELISA)

    Measured: 3 months

  28. Adiposity

    Fat mass/fat free mass evaluated by bioimpedance

    Measured: baseline

  29. Adiposity

    Fat mass/fat free mass evaluated by bioimpedance

    Measured: 1 month

  30. Adiposity

    Fat mass/fat free mass evaluated by bioimpedance

    Measured: 3 months

  31. Obesity

    Body weight

    Measured: baseline

  32. Obesity

    Body weight

    Measured: 1 month

  33. Obesity

    Body weight

    Measured: 3 months

  34. Dietary habits

    the frequency of certain food consumption (rank score) by means of validated Food Frequency Questionnaire (FFQ).

    Measured: baseline

  35. 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).

    Measured: baseline

  36. Functions of peripheral blood mononuclear cells (PBMCs)

    mass cytometry (CyTOF)

    Measured: baseline

  37. Functions of peripheral blood mononuclear cells (PBMCs)

    mass cytometry (CyTOF)

    Measured: 1 month

  38. Functions of peripheral blood mononuclear cells (PBMCs)

    mass cytometry (CyTOF)

    Measured: 3 months

  39. Insulin resistance

    HOMA-Homeostasis Model Assessment calculated from fasted glycemia and insulinemia

    Measured: baseline

  40. Insulin resistance

    HOMA-Homeostasis Model Assessment calculated from fasted glycemia and insulinemia

    Measured: 1 month

  41. Insulin resistance

    HOMA-Homeostasis Model Assessment calculated from fasted glycemia and insulinemia

    Measured: 3 months

  42. carbohydrate metabolism

    glycated hemoglobin (HbA1c)

    Measured: baseline

  43. carbohydrate metabolism

    glycated hemoglobin (HbA1c)

    Measured: 1 month

  44. carbohydrate metabolism

    glycated hemoglobin (HbA1c)

    Measured: 3 months

  45. Concentration of blood lipids

    Analysis of circulating lipids : total, LDL and HDL cholesterol (mg/dl), triglycerides (md/dl)

    Measured: baseline

  46. Concentration of blood lipids

    Analysis of circulating lipids : total, LDL and HDL cholesterol (mg/dl), triglycerides (md/dl)

    Measured: 1 month

  47. Concentration of blood lipids

    Analysis of circulating lipids : total, LDL and HDL cholesterol (mg/dl), triglycerides (md/dl)

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Feb 2023
  2. Study start24 Oct 2023
  3. Primary completion10 Mar 2025
  4. Study completion10 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
parallel-groups, randomized, placebo-controlled clinical study
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
202 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05738746
Sponsor's protocol ID
101095540
Acronym
MENTAkHEALTH
Status last verified
Mar 2025
First submitted
30 Jan 2023
Last updated
18 Mar 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: 1. Personal data will be pseudonymised and encrypted, and after the purpose of processing has ceased to exist, they will be deleted or made anonymous. 2. Personal data will be processed in compliance with the technical and organizational measures referred to in Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 and the Data Protection Policy at PMU. 3. Research data will be made available in the open research data repository, at the latest when the research article is published, after the end of its analysis. 4. There are no restrictions or obstacles preventing full disclosure of data. 5. Sharing data requires no consent of the study participants as for the anonymous character of the study 6. Only data from sequencing analyzes will be stored indefinitely in the repository https://qiita.ucsd.edu/ 7. The remaining data will be deposited for a minimum of 10 years in the ZENODO repository

Publications

  • 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.

    PubMed 31263284

  • 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.

    PubMed 26563823

  • 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.

    PubMed 32725676

  • 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.

    PubMed 35641786

Questions about this trial

What is this clinical trial studying?

A study testing Pasteurized Akkermansia muciniphila in people with Stress and Healthy, run by Pomeranian Medical University Szczecin at 2 sites in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Stress intensity (time frame: baseline). The study lists 33 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05738746, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2025.

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