Metabolic SyndromeNCT05114018
Effect of Pasteurized Akkermansia Muciniphila on Insulin Resistance in Otherwise Healthy Subjects With Dysglycaemia
A study testing Pasteurized A. muciniphila in people with Metabolic Syndrome and Pre-diabetes, run by A-Mansia Biotech S.A. at 2 sites in 2 countries.
Trial summary
The purpose of this study is to demonstrate the efficacy of pasteurized Akkermansia muciniphila (pAKK) in improving insulin sensitivity in hyperglycaemic, but otherwise healthy persons with metabolic syndrome. This is the primary objective of this study. Read more about this study
- Who is it for?
- Ages 21 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome, Pre-diabetes, Overweight and Obesity
- What is being tested?
- Pasteurized A. muciniphila
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 143 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 24 Jun 2020to 31 Aug 2023
- 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 21 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Written informed consent;
- BMI between >25 and <40 Kg/m2;
- Qualifying for the diagnosis of metabolic syndrome according to the International Diabetes Federation (IDF 2006) criteria. At least any three of five citeria, with the modification that the criterion FPG≥100 mg/dL (5.6 mmol/L) is required among at least three of five:
- Increased waist circumference: for Europid, sub-Saharan African, Eastern and Middle-Eastern ≥94 cm (men) or ≥80 cm (women), with ethnic-specific waist circumference cut-points: for South Asian and Chinese patients, waist ≥90 cm (men) or ≥80 cm (women); for Japanese patients, waist ≥90 cm (men) or ≥80 cm (women);
- Triglycerides ≥150 mg/dL (1.7 mmol/L) (exception: triglycerides ≥100 mg/dL (1.13mmol/L) for sub-Saharan African) or treatment for elevated triglycerides;
- HDL cholesterol <40 mg/dL (1.03 mmol/L) in men or <50 mg/dL (1.29 mmol/L) in females, or treatment for low HDL;
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- Systolic blood pressure ≥130, diastolic blood pressure ≥85 mmHg, or treatment for hypertension;
- FPG ≥100 mg/dL (5.6 mmol/L) or previously diagnosed type 2 diabetes; an oral glucose tolerance test is recommended for patients with an elevated FPG, but it is not required.
- If participant has a prior diagnosis of pre-diabetes or Type II diabetes, and has been unmedicated for 3-months prior to screening;
- If female, must meet all the following criteria:
- Not pregnant or breastfeeding
- If of childbearing potential (including peri-menopausal women who have had a menstrual period within one year) must practice and be willing to continue to practice appropriate birth control (defined as a method which results in a low failure rate, i.e., less than 1% per year, when used consistently and correctly, such as double barrier methods [male condom with spermicide, with or without cervical cap or diaphragm], implants, injectable or oral contraceptives [must have been using for at least the last 3 months], some intrauterine contraceptive devices, tubal ligation, or in an established relationship with a vasectomized partner) during the entire duration of the study
- Be willing to maintain stable dietary habits and physical activity levels throughout the trial period;
- Be able to communicate well with the Investigator, to understand and comply with the requirements of the study and be judged suitable for the study in the opinion of the Investigator.
- Within 3 months following to the exit of the study for failure to comply with one or more of the inclusion criteria listed above, a re-screening could be performed.
Who cannot join
- Uncontrolled hyperglycemia assessed by HbA1c ≥ 6.5%;
- Suffering from a metabolic disorder such as diabetes mellitus that requires lifesyle and dietary recommendations or a medication according to the recommendations, uncontrolled thyroidal trouble (Confirmed by clinical significant abnormal TSG/T4 and/or stabled medication for >3 months) or other metabolic disorder;
- Suffering from a severe chronic disease (e.g., cancer, HIV, renal failure, hepatic or biliary disorders ongoing, chronic inflammatory digestive disease, inflammatory bowel disease, irritable bowel syndrome, arthritis or other chronic respiratory trouble, etc.) or gastrointestinal disorders found to be inconsistent with the conduct of the study by the investigator (e.g., celiac disease);
- With a history of retinopathy, microalbuminuria, ischemic cardiovascular event during the previous 6 months;
- Consumption of more than 30 g of dietary fibre per day, as measured by the Block Fibre Screener
- Prior diagnosis of Type I diabetes mellitus (i.e., a clinical diagnosis made before the screening visit of this study);
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- Alcohol consumption (>21 units per week);
- Smoking more than 10 cigarettes per day;
- Previous bariatric surgery;
- Any surgery in the 3 months before the study or planned for 6 months after enrolling;
- Pregnancy or pregnancy planned in the 6 months after enrolling or lactating women;
- Consumption of dietary supplements (omega-3 fatty acids, probiotics, prebiotics, plant stanols/sterols) in the 4-weeks before the study;
- Presence or history of significant and diagnosed gastrointestinal diseases that, in the opinion of the investigator, could be associated with disturbed gastrointestinal absorption (e.g., resections, diverticula, active and diagnostically confirmed irritable bowel syndrome, malabsorption syndrome);
- Present or recent (within 3-months of screening) use of any other medication which, in the opinion of the investigator, could interfere with the outcome of the study, including but not limited to antithrombotic agents, anti-inflammatory agents and chronic NSAID use (except low-dose prophylactic, proton pump inhibitors (PPIs), antihistamines, if ongoing (3-months) and on a stable dose throughout study period);
- Steroids (over the counter (OTC) NSAIDS, topical steroids and inhalers are allowed)
- Current or planned participation in a weight-loss regimen (including intermediate fasting), including extreme dietary practices or exercise;
- Anorexia nervosa, bulimia or significant eating disorders according to the investigators;
- Having lost >5% of their body weight within 3-months prior to screening;
- Lactose intolerance or milk protein allergy;
- Gluten intolerance;
- Current treatment with medications influencing the parameters of interest (glucose-lowering drugs such as metformin, DPP4 inhibitors, GLP-1 receptor agonists, acarbose, sulfonylureas, glinides, thiazolidinediones, sodium-glucose cotransporter -2 inhibitors, insulin, lactulose, glucocorticoids, immunosuppressive agents, , orlistat, cholestyramine or ezetimibe);
- Antibiotic use in the 3 months before the study;
- Participant has a known allergy to inactive or active ingredients in the study products;
- Participation in other clinical research trials within 90 days prior to randomization;
- Any other condition which in the Investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Study to Investigate the Effects of 'Next Generation Beneficial Microbes', Akkermansia Muciniphila (AMF-01), on Long-term Improvements in Insulin Resistance in Otherwise Healthy Hyperglycaemic Adults
The purpose of this study is to demonstrate the efficacy of pasteurized Akkermansia muciniphila (pAKK) in improving insulin sensitivity in hyperglycaemic, but otherwise healthy persons with metabolic syndrome. This is the primary objective of this study. Secondary objectives consist of evaluation of the effects of next generation beneficial microbes on metabolic health, anthropometry and body composition, and safety.
Therefore, the trial is designed as a phase 2, randomized, double-blind, placebo-controlled, parallel group, multi-center trial comparing pAKK with placebo in restoring insulin sensitivity in dysglycaemic but otherwise healthy subjects with metabolic syndrome.
In total, 144 enrolled participants will attend 6 study visits in total. Study visits may be conducted in the clinic, at home by a Healthcare Professional, or by telephone / telemedicine.
Read the detailed description
Overweight and obesity have reached worldwide epidemic level. Observation of elevated glycaemia like impaired fasting glucose and impaired glucose tolerance are reflecting pre-diabetic states often occurring in the context of development of insulin resistance in persons with metabolic syndrome. Moreover, this status is associated with the risk for developing type 2 diabetes as well as cardiovascular disease. In a proof of concept study the supplementation with A. muciniphila was safe and improved metabolic health in persons with metabolic syndrome.
The purpose of this study is to demonstrate the efficacy of pasteurized Akkermansia muciniphila (pAKK) in improving insulin sensitivity in hyperglycaemic, but otherwise healthy persons with metabolic syndrome. This is the primary objective of this study. Secondary objectives consist of evaluation of the effects of next generation beneficial microbes on metabolic health, anthropometry and body composition, and safety.
Therefore, the trial is designed as a phase 2, randomized, double-blind, placebo-controlled, parallel group, multi-center trial comparing pAKK with placebo in restoring insulin sensitivity in dysglycaemic but otherwise healthy subjects with metabolic syndrome.
In total, 144 enrolled participants will attend 6 study visits in total. Study visits may be conducted in the clinic, at home by a Healthcare Professional, or by telephone / telemedicine.
- Conditions
- Metabolic Syndrome, Pre-diabetes, Overweight and Obesity
- Being tested
- Pasteurized A. muciniphila, placebo
- Medical subject headings
- Metabolic Syndrome, Glucose Intolerance, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pasteurized A. muciniphilaDietary supplement
Daily oral dose
placeboDietary supplement
Placebo = identical to verum regarding the form, size, taste, color and intake
| Study group | Role | What they receive |
|---|---|---|
| Experimental group receiving pasteurized Akkermansia muciniphila | Experimental | Experimental group receiving pasteurized Akkermansia muciniphila. Receives: Dietary Supplement: Pasteurized A. muciniphila |
| Control group | Placebo comparator | Control group receiving placebo, identical to verum regarding the form, size, taste, color and intake. Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin sensitivity by Matsuda Index
Absolute change from baseline to day 120 in treatment group as compared to placebo in insulin sensitivity as determined by Matsuda.
Measured: From baseline to day 120
Secondary outcomes (21)
Insulin sensitivity by homeostasis model assessment-estimated (HOMA) insuline sensitivity
change in treatment group as compared to placebo by measuring fasting glucose and insulin values
Measured: From baseline to day 120
fasting blood glucose
change in treatment group as compared to placebo
Measured: From baseline to day 120
3-hour blood glucose incremental Area Under the Curve (AUC) as measured by Oral Glucose Tolerance Test (OGTT)
change in treatment group as compared to placebo
Measured: From baseline to day 120
Peak Plasma Concentration (Cmax) of blood glucose as measured by OGTT
change in treatment group as compared to placebo
Measured: From baseline to day 120
3-hour blood insulin incremental Area Under the Curve (AUC) as measured by OGTT
change in treatment group as compared to placebo
Measured: From baseline to day 120
Peak Plasma Concentration (Cmax) of blood insulin as measured by OGTT
change in treatment group as compared to placebo
Measured: From baseline to day 120
Glycosylated hemoglobin (HbA1c)
change in treatment group as compared to placebo
Measured: From baseline to day 120
Postprandial triglyceride (TG) response as incremental Area Under the Curve (AUC) as measured by OGTT
change in treatment group as compared to placebo
Measured: From baseline to day 120
Peak Plasma Concentration (Cmax) of blood TG as measured by OGTT
change in treatment group as compared to placebo
Measured: From baseline to day 120
Blood lipid profile by total cholesterol, TG, low density lipoprotein, high density lipoprotein, non-esterified fatty acids
change in treatment group as compared to placebo
Measured: From baseline to day 120
Liver enzymes (ALT, AST, GGT, bilirubin, alkaline phosphatase)
change in treatment group as compared to placebo
Measured: From baseline to day 120
Anthropometry by Height (m) and body weight (kg) combined into BMI (kg/m2)
change in treatment group as compared to placebo
Measured: From baseline to day 120
Circumference (cm) of waist, hip and neck and waist, hip and height measurement will be combined into Waist-to-Hip ratio (W:H) and Waist-to-Height ratio (WHtR)
change in treatment group as compared to placebo
Measured: From baseline to day 120
Body composition by measurement of body fat mass by DEXA measurement
change in treatment group as compared to placebo
Measured: From baseline to day 120
Body composition by measurement of lean mass by DEXA measurement
change in treatment group as compared to placebo
Measured: From baseline to day 120
Body composition by measurement of trunk fat mass by DEXA measurement
change in treatment group as compared to placebo
Measured: From baseline to day 120
Vital signs: heart rate
evaluation of heart rate
Measured: From baseline to day 120
Vital signs: blood pressure
evaluation of Systolic blood pressure (SBP) (mmHg) and diastolic blood pressure (DBP) (mmHg)
Measured: From baseline to day 120
Vital signs: body temperature
evaluation of body temperature
Measured: From baseline to day 120
Vital signs: respiratory rate
evaluation of respiratory rate
Measured: From baseline to day 120
Adverse events
evaluation of occurrence of the nature, frequency, severity and relatedness of adverse events as well as clinically significant laboratory values
Measured: From baseline to day 120
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2021
- Study start24 Jun 2020
- Primary completion28 Jul 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- randomized, double-blind, placebo-controlled, parallel group, multi-center trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- A-Mansia Biotech S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Suenaert, MD, PhD, Study director, R&D and Clinical Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05114018
- Sponsor's protocol ID
- AFCRO-117
- Status last verified
- Sep 2023
- First submitted
- 7 Oct 2021
- Last updated
- 8 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 31263284Suenaert P, Segers A, Rymenans L, Devroye H, Moll JM, Cani PD, de Vos WM. Effect of pasteurized Akkermansia muciniphila MucT on insulin sensitivity, body composition, and GLP-1 production in subjects with metabolic syndrome: impact of low baseline gut Akkermansia levels. Gut Microbes. 2026 Dec 31;18(1):2690689. doi: 10.1080/19490976.2026.2690689. Epub 2026 Jun 24.
PubMed 42343233
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Study to Investigate the Effects of 'Next Generation Beneficial Microbes', Akkermansia Muciniphila (AMF-01), on Long-term Improvements in Insulin Resistance in Otherwise Healthy Hyperglycaemic Adults
- ClinicalTrials.gov ID
- NCT05114018
- Acronym / sponsor ID
- AFCRO-117
- Conditions
- Metabolic Syndrome, Pre-diabetes, Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- A-Mansia Biotech S.A.Industry (pharma, biotech, devices)
- Study start
- 24 Jun 2020 (actual)
- Primary completion
- 28 Jul 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 9 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to demonstrate the efficacy of pasteurized Akkermansia muciniphila (pAKK) in improving insulin sensitivity in hyperglycaemic, but otherwise healthy persons with metabolic syndrome. This is the primary objective of this study. Secondary objectives consist of evaluation of the effects of next generation beneficial microbes on metabolic health, anthropometry and body composition, and safety.
Therefore, the trial is designed as a phase 2, randomized, double-blind, placebo-controlled, parallel group, multi-center trial comparing pAKK with placebo in restoring insulin sensitivity in dysglycaemic but otherwise healthy subjects with metabolic syndrome.
In total, 144 enrolled participants will attend 6 study visits in total. Study visits may be conducted in the clinic, at home by a Healthcare Professional, or by telephone / telemedicine.
Detailed description
Overweight and obesity have reached worldwide epidemic level. Observation of elevated glycaemia like impaired fasting glucose and impaired glucose tolerance are reflecting pre-diabetic states often occurring in the context of development of insulin resistance in persons with metabolic syndrome. Moreover, this status is associated with the risk for developing type 2 diabetes as well as cardiovascular disease. In a proof of concept study the supplementation with A. muciniphila was safe and improved metabolic health in persons with metabolic syndrome.
The purpose of this study is to demonstrate the efficacy of pasteurized Akkermansia muciniphila (pAKK) in improving insulin sensitivity in hyperglycaemic, but otherwise healthy persons with metabolic syndrome. This is the primary objective of this study. Secondary objectives consist of evaluation of the effects of next generation beneficial microbes on metabolic health, anthropometry and body composition, and safety.
Therefore, the trial is designed as a phase 2, randomized, double-blind, placebo-controlled, parallel group, multi-center trial comparing pAKK with placebo in restoring insulin sensitivity in dysglycaemic but otherwise healthy subjects with metabolic syndrome.
In total, 144 enrolled participants will attend 6 study visits in total. Study visits may be conducted in the clinic, at home by a Healthcare Professional, or by telephone / telemedicine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized, double-blind, placebo-controlled, parallel group, multi-center trial
| Arm | Type | Receives |
|---|---|---|
| Experimental group receiving pasteurized Akkermansia muciniphila | Experimental | Dietary Supplement: Pasteurized A. muciniphilaExperimental group receiving pasteurized Akkermansia muciniphila. |
| Control group | Placebo comparator | Dietary Supplement: placeboControl group receiving placebo, identical to verum regarding the form, size, taste, color and intake. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Written informed consent;
- BMI between >25 and <40 Kg/m2;
- Qualifying for the diagnosis of metabolic syndrome according to the International Diabetes Federation (IDF 2006) criteria. At least any three of five citeria, with the modification that the criterion FPG≥100 mg/dL (5.6 mmol/L) is required among at least three of five:
- If participant has a prior diagnosis of pre-diabetes or Type II diabetes, and has been unmedicated for 3-months prior to screening;
- If female, must meet all the following criteria:
Key exclusion criteria (25 listed)
- Uncontrolled hyperglycemia assessed by HbA1c ≥ 6.5%;
- Suffering from a metabolic disorder such as diabetes mellitus that requires lifesyle and dietary recommendations or a medication according to the recommendations, uncontrolled thyroidal trouble (Confirmed by clinical significant abnormal TSG/T4 and/or stabled medication for >3 months) or other metabolic disorder;
- Suffering from a severe chronic disease (e.g., cancer, HIV, renal failure, hepatic or biliary disorders ongoing, chronic inflammatory digestive disease, inflammatory bowel disease, irritable bowel syndrome, arthritis or other chronic respiratory trouble, etc.) or gastrointestinal disorders found to be inconsistent with the conduct of the study by the investigator (e.g., celiac disease);
- With a history of retinopathy, microalbuminuria, ischemic cardiovascular event during the previous 6 months;
- Consumption of more than 30 g of dietary fibre per day, as measured by the Block Fibre Screener
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pasteurized A. muciniphilaDaily oral dose | Dietary supplement | Experimental group receiving pasteurized Akkermansia muciniphila |
| placeboPlacebo = identical to verum regarding the form, size, taste, color and intake | Dietary supplement | Control group |
Primary outcome
Insulin sensitivity by Matsuda Index
Time frame: From baseline to day 120
Absolute change from baseline to day 120 in treatment group as compared to placebo in insulin sensitivity as determined by Matsuda.
21 secondary outcomes
Insulin sensitivity by homeostasis model assessment-estimated (HOMA) insuline sensitivity
Time frame: From baseline to day 120
fasting blood glucose
Time frame: From baseline to day 120
3-hour blood glucose incremental Area Under the Curve (AUC) as measured by Oral Glucose Tolerance Test (OGTT)
Time frame: From baseline to day 120
Peak Plasma Concentration (Cmax) of blood glucose as measured by OGTT
Time frame: From baseline to day 120
3-hour blood insulin incremental Area Under the Curve (AUC) as measured by OGTT
Time frame: From baseline to day 120
Peak Plasma Concentration (Cmax) of blood insulin as measured by OGTT
Time frame: From baseline to day 120
Glycosylated hemoglobin (HbA1c)
Time frame: From baseline to day 120
Postprandial triglyceride (TG) response as incremental Area Under the Curve (AUC) as measured by OGTT
Time frame: From baseline to day 120
Peak Plasma Concentration (Cmax) of blood TG as measured by OGTT
Time frame: From baseline to day 120
Blood lipid profile by total cholesterol, TG, low density lipoprotein, high density lipoprotein, non-esterified fatty acids
Time frame: From baseline to day 120
Liver enzymes (ALT, AST, GGT, bilirubin, alkaline phosphatase)
Time frame: From baseline to day 120
Anthropometry by Height (m) and body weight (kg) combined into BMI (kg/m2)
Time frame: From baseline to day 120
Circumference (cm) of waist, hip and neck and waist, hip and height measurement will be combined into Waist-to-Hip ratio (W:H) and Waist-to-Height ratio (WHtR)
Time frame: From baseline to day 120
Body composition by measurement of body fat mass by DEXA measurement
Time frame: From baseline to day 120
Body composition by measurement of lean mass by DEXA measurement
Time frame: From baseline to day 120
Body composition by measurement of trunk fat mass by DEXA measurement
Time frame: From baseline to day 120
Vital signs: heart rate
Time frame: From baseline to day 120
Vital signs: blood pressure
Time frame: From baseline to day 120
Vital signs: body temperature
Time frame: From baseline to day 120
Vital signs: respiratory rate
Time frame: From baseline to day 120
Adverse events
Time frame: From baseline to day 120
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2025.
- Background: PubMed 31263284Depommier 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.
- Derived from this study: PubMed 42343233Suenaert P, Segers A, Rymenans L, Devroye H, Moll JM, Cani PD, de Vos WM. Effect of pasteurized Akkermansia muciniphila MucT on insulin sensitivity, body composition, and GLP-1 production in subjects with metabolic syndrome: impact of low baseline gut Akkermansia levels. Gut Microbes. 2026 Dec 31;18(1):2690689. doi: 10.1080/19490976.2026.2690689. Epub 2026 Jun 24.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Suenaert, MD, PhD study director
R&D and Clinical Development
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pasteurized A. muciniphila in people with Metabolic Syndrome and Pre-diabetes, run by A-Mansia Biotech S.A. at 2 sites in 2 countries.
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 15 inclusion and 25 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 8 Jun 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 Germany, Ireland. 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?
Insulin sensitivity by Matsuda Index (time frame: From baseline to day 120). 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 NCT05114018, which also lists 2 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 8 Jun 2025.