ObesityAmansiaNCT05417360
Akkermansia and Weight Maintenance
A study testing Akkermansia muciniphila in people with Obesity and Microtia, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Obesity and related disorders such as type 2 diabetes are a worldwide diet-related problem. As such new treatment options are constantly being developed. Bacteria living in the gut seem to be a key player in the treatment of obesity and related metabolic diseases by influencing energy balance and the immune system. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Microtia, Metabolic Syndrome
- What is being tested?
- Akkermansia muciniphila
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteNetherlands
- Study dates
- 22 Jul 2022to 20 Nov 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 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI ≥ 28 kg/m2 < 40 kg/m2
- Weight stable for at least 3 months (± 2 kg).
Who cannot join
- Type 2 diabetes mellitus (fasting plasma glucose ≥ 7.0 mmol/L)
- Gastroenterological diseases
- Surgery on the gastrointestinal tract (ex.Bariatric surgery)
- Cardiovascular diseases, cancer, liver or kidney malfunction, a disease with a life expectancy of < 5 years;
- Alcohol (>15 standard drinks per week) or drug abuse
- Excessive nicotine use is defined as >20 cigarettes per day;
Show all 15Show fewer
- Use of prebiotics or probiotics 3 months prior to the start of the study;
- Intensive exercise training, > 3 hours a week;
- Use of any medication influencing glucose or fat metabolism (ex. lipid-lowering-drugs e.g. PPAR γ (peroxisome proliferator-activated receptors) or PPARα (fibrates) agonists), glucose-lowering agents (including all sulfonylureas, biguanides, α-glucosidase inhibitors, thiazolidinediones, repaglinide, nateglinide, and insulin), inflammation (e.g. anti-inflammatory or immunosuppressive drugs) and anti-oxidants);
- Regular use of laxatives
- Use of antibiotics in the last 3 months
- Vegan
- Lactose intolerance
- Pregnancy or lactation
- Concomitant participation in another study
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Department of Human Biology, Maastricht University Medical Centre
Maastricht, Limburg, 6200MD
About this study
Official title: Effect of Pasteurized Akkermansia Muciniphilia on Maintenance of Body Weight After a Low Calorie Diet
Obesity and related disorders such as type 2 diabetes are a worldwide diet-related problem. As such new treatment options are constantly being developed. Bacteria living in the gut seem to be a key player in the treatment of obesity and related metabolic diseases by influencing energy balance and the immune system. In terms of newly identified bacteria species, Akkermansia muciniphila (A. muciniphila) has been found to be related to obesity. Several animal studies have shown the beneficial impact of A. muciniphila on the treatment of body weight as well as insulin sensitivity.
The growth requirements of live A. muciniphila as well as its oxygen sensitivity rendered this bacterium unsuitable for human investigations or putative therapeutic opportunities. Therefore, pasteurization, a mild heating method, and its impact on diet-induced metabolic disorders in mice were investigated. Unexpectedly, this method of inactivation did not negate the effect of A. muciniphila, but improved its beneficial metabolic effects. Pilot studies have provided further evidence that pasteurization of A. muciniphila is safe for human use and has the potential to beneficially affect the control of body weight and glucose metabolism.
In this project, The investigators hypothesize that pasteurized A. muciniphila will be superior to placebo intervention in maintaining body weight after a phase of weight loss (low caloric diet) in adult participants with overweight or obesity.
Read the detailed description
RATIONALE This study will examine the influence of specific beneficial gut bacteria in relation to weight maintenance. The worldwide prevalence of obesity, obesity-associated insulin resistance, and type 2 Diabetes Mellitus (T2DM) has grown dramatically over the last couple of decades; in every region of the world, obesity prevalence has more than tripled since 1975. Even though obesity treatment strategies, such as lifestyle interventions (focussed on diet and/or physical activity) and bariatric surgery have improved, there is extensive variability in responses. In the short term, reducing body weight is relatively easy, for most people. However, maintaining weight loss in the long term is a challenge. Hence, novel strategies to reduce these pandemics and support weight maintenance are strongly warranted.
The gut microbiome has emerged as an important regulator of host energy metabolism, thereby contributing to the etiology of obesity and obesity-related insulin resistance. However, scientific evidence is mainly derived from animal experiments and association studies, and support for causality in humans using mechanistic studies is limited. The influence of a newly identified bacterium, A. muciniphila. has been shown to be associated with a healthy intestine, and its abundance is inversely correlated to several disease states amongst others obesity and insulin resistance. However, the growth requirements of live A. muciniphila as well as its oxygen sensitivity(12) rendered this bacterium unsuitable for human investigations or putative therapeutic opportunities. Therefore, pasteurization, a mild heat inactivation method (30 min at 70 degrees Celsius), and its impact on diet-induced metabolic disorders in mice were investigated. Unexpectedly, this method of inactivation did not abolish the effect of A. muciniphila but even exacerbated its beneficial impacts. In mice, daily administration of pasteurized A. muciniphila alleviates diet-induced obesity. Moreover, a randomized, double-blind, placebo-controlled proof-of-concept study in overweight/obese insulin-resistant adults showed that the daily supplementation with pasteurized A. muciniphila for 12 weeks improved several metabolic parameters such as insulin sensitivity, insulinemia, plasma total cholesterol, as well as relevant blood markers for liver dysfunction and inflammation independently from any caloric restriction or modification of the physical activity. The investigators hypothesize that pasteurized A. muciniphila will be superior to placebo intervention in maintaining body weight after a low caloric diet in participants with overweight or obesity.
OBJECTIVES
- To investigate the effects of pasteurized A. muciniphila on the maintenance of body weight after a phase of weight loss.
- To investigate the effects of pasteurized A. muciniphila on body composition and body fat distribution, glucose homeostasis and insulin sensitivity, and metabolic health.
- To investigate the effects of pasteurized A. muciniphila on the fecal bacterial composition and functionality, systemic inflammation, and gut barrier function and identify relevant biomarkers.
STUDY DESIGN The proposed study is a 32-week double-blind placebo-controlled randomized trial in 108 healthy overweight/ obese (BMI ≥ 28 kg/m2 < 40 kg/m2) Dutch adults, aged 20-70 years. All participants will follow a commercially-prepared low-calorie diet, with 15-20 energy % from fat, 35-40 energy % from protein, and 45-50 energy % from carbohydrates for a period of 8 weeks, to lose 8% of their body weight. In addition to these prepared meals, participants will be allowed limited consumption of specific low-calorie vegetables. Participants will be randomized to either the placebo or the intervention group following the weight-loss period. The weight loss phase will be followed by a 24-week supplementation placebo or active ingredient and a weight maintenance period. Prior to, as well as during both phases of the study participants will receive regular weigh-ins (weeks 0, 1, 4, 8, 16, 24, and 32) and counseling from a registered dietician. In addition to measuring changes in weight and physical measurements, participants will fill in questionnaires, and provide blood and fecal samples at weeks 0, 8, and 32.
QUALITY ASSURANCE Study activities will be carried out by qualified trained personnel, following standard operating procedures (SOP's). All research activities, including data entry and SOP compliance, will be monitored by an independent monitoring board, Clinical trial center Maastricht (CTCM). Data will be analyzed and handled according to the data management and statistical analysis plan.
- Conditions
- Obesity, Microtia, Metabolic Syndrome, Weight Loss
- Being tested
- Akkermansia muciniphila, Placebo
- Medical subject headings
- Obesity, Congenital Microtia, Metabolic Syndrome, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Akkermansia muciniphilaDietary supplement
During the weight management period (weeks 8 to 32), the pasteurized A. muciniphila product will be orally consumed in water at least 15 min before breakfast for a period of 6 months (24 weeks) capsules. It appears as a white homogenous powder.
.
PlaceboDietary supplement
During the weight management period (weeks 8 to 32), the placebo product will be orally consumed in water at least 15 min before breakfast for a period of 6 months (24 weeks). It appears as a white homogenous powder.
| Study group | Role | What they receive |
|---|---|---|
| Akkermansia muciniphila (A. muciniphila) | Experimental | After an 8-week low caloric diet (LCD, ~800kcal), participants who have successfully lost 8% of their body weight who are randomized to the intervention group, will receive pasteurized A. muciniphila. Receives: Dietary Supplement: Akkermansia muciniphila |
| Placebo | Placebo comparator | After an 8-week low caloric diet (LCD, ~800kcal), participants who have successfully lost 8% of their body weight who are randomized to the control group, will receive a placebo. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
Changes in body weight following the initial weight loss period will be monitored over the weight maintenance period.
Measured: 6 months
Secondary outcomes (20)
Body composition
Changes in body composition following the initial weight-loss period as assessed by dual-energy X-ray absorptiometry (DEXA), and body mass index (BMI).
Measured: 8 months
Body fat distribution
Changes in body fat distribution following the initial weight-loss period as assessed by the waist to hip ratio, as measured by waist and hip circumferences.
Measured: 8 months
Glucose metabolism
Changes in glucose metabolism will be assessed by fasting glucose and hemoglobin A1C (HBA1c).
Measured: 8 months
Insulin sensitivity
Changes in glucose and insulin responses to a 7 point oral glucose tolerance test.
Measured: 8 months
Lipid profile
Changes in total cholesterol, triglycerides (TG), low-density lipoprotein) (LDL), high-density lipoprotein (HDL), and non - esterified fatty acids (NEFA) will be considered together to give an indication of the overall lipid profile as a result of the LCD and active intervention.
Measured: 8 months
Adipose tissue activity
Changes in adipose tissue gene/protein expression will be assessed.
Measured: 8 months
Gut barrier function
Gut barrier function will be assessed using serum/fecal zonulin, fecal calprotectin, serum LBP, and serum LPS. These measurements will be considered together to give an indication as to the function of the gut barrier, i.e. if it is normal, disrupted, or has improved as a result of the LCD and or active intervention.
Measured: 8 months
Psychological well-being - mental health
Well-being, as it relates to feelings of depression and anxiety, will be measured using the Hospital Anxiety and Depression Scale (HADS) questionnaire.
Measured: 8 months
Psychological well-being - sleep quality
Well-being, as it relates to sleep and sleep quality, will be assessed using the Pittsburgh Sleep Quality Index (PSQI)
Measured: 8 months
Psychological well-being - stress
Well-being, as it relates to perceived stress, will be assessed using the 10-item Perceived Stress Scale (PSS).
Measured: 8 months
Psychological well-being - General
general well-being will be assessed using the 36-Item Short-Form Health Survey (Rand - 36/ SF-36) .
Measured: 8 months
Gastrointestinal symptoms - bowel movements
Gastrointestinal symptoms related to bowel movement frequency and consistency will be measured using the Bristol Stool Charts (BSC).
Measured: 8 months
Gastrointestinal symptoms
Gastrointestinal symptoms will be measured using the Gastrointestinal Symptom Rating Scale questionnaire.
Measured: 8 months
Heart rate
Changes in heart rate will be monitored over time
Measured: 8 months
Blood pressure
Changes in blood pressure (systolic blood pressure (SBP), diastolic blood pressure (DBP)) will be measured over time.
Measured: 8 months
Renal function
Changes in renal function, before during, and after the LCD and intervention will be monitored with blood creatinine, sodium, potassium, and chloride concentrations. These measurements will be considered together to determine if renal function is stable, has deteriorated, or improved.
Measured: 8 months
Liver function
Changes in liver function will be monitored before during and after the LCD and active intervention using blood alanine aminotransferase (ALAT), aspartate transaminase (ASAT), alkaline phosphatase (ALP), gamma-glutamyltransferase (GGT), bilirubin, and, albumin. These measurements will be considered together to determine if liver function is stable, has deteriorated, or improved.
Measured: 8 months
Inflammation
Inflammation will be monitored using C- reactive protein (CRP), lipopolysaccharide-binding protein (LBP), lipopolysaccharide (LPS), and serum zonulin.
Measured: 8 months
Microbiota
Fecal samples to be used for analyzing microbiota composition will be collected and compared between groups.
Measured: 8 months
Short chain fatty acid production
Circulating fatty acids will be measured as a measure of function of the microbiota
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2022
- Study start22 Jul 2022
- Primary completion20 Nov 2023
- Study completion20 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A double-blind, placebo-controlled randomised intervention study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05417360
- Sponsor's protocol ID
- NL80563.068.22
- Acronym
- Amansia
- Status last verified
- Nov 2023
- First submitted
- 24 May 2022
- Last updated
- 27 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: After completing the study, the generated data will be shared pseudo-anonymized (participant code, but no private data of the participants will be shared) with the subsiding party A-Mansia Biotech. There are no restrictions with respect to the publication of the data. Both positive and negative results of the studies will be made public, preferably in peer-reviewed international scientific journals, according to the Central Committee on Research involving Human Subjects (CCMO) statement of publication policy. The authorship of the article shall be determined with consideration based on the contribution to the set-up and execution of the study and active participation in publication. Further, this study will be registered in a public trial registry before the first volunteer will be recruited.
Publications
Mount S, Canfora EE, Jocken JW, Umanets A, Hul G, Coenjaerds M, Aldaz Laquidain P, Adriaens ME, Holst JJ, Jardon KM, Segers A, Suenaert P, de Vos WM, Blaak EE. Pasteurized Akkermansia muciniphila MucT for weight loss maintenance in people with overweight and obesity: a controlled randomized trial. Nat Med. 2026 Jun;32(6):2107-2116. doi: 10.1038/s41591-026-04394-7. Epub 2026 May 13.
PubMed 42120725
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pasteurized Akkermansia Muciniphilia on Maintenance of Body Weight After a Low Calorie Diet
- ClinicalTrials.gov ID
- NCT05417360
- Acronym / sponsor ID
- Amansia / NL80563.068.22
- Conditions
- Obesity, Microtia, Metabolic Syndrome, Weight Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 22 Jul 2022 (actual)
- Primary completion
- 20 Nov 2023 (actual)
- Study completion
- 20 Nov 2023 (actual)
- First posted
- 14 Jun 2022 (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.
Obesity and related disorders such as type 2 diabetes are a worldwide diet-related problem. As such new treatment options are constantly being developed. Bacteria living in the gut seem to be a key player in the treatment of obesity and related metabolic diseases by influencing energy balance and the immune system. In terms of newly identified bacteria species, Akkermansia muciniphila (A. muciniphila) has been found to be related to obesity. Several animal studies have shown the beneficial impact of A. muciniphila on the treatment of body weight as well as insulin sensitivity.
The growth requirements of live A. muciniphila as well as its oxygen sensitivity rendered this bacterium unsuitable for human investigations or putative therapeutic opportunities. Therefore, pasteurization, a mild heating method, and its impact on diet-induced metabolic disorders in mice were investigated. Unexpectedly, this method of inactivation did not negate the effect of A. muciniphila, but improved its beneficial metabolic effects. Pilot studies have provided further evidence that pasteurization of A. muciniphila is safe for human use and has the potential to beneficially affect the control of body weight and glucose metabolism.
In this project, The investigators hypothesize that pasteurized A. muciniphila will be superior to placebo intervention in maintaining body weight after a phase of weight loss (low caloric diet) in adult participants with overweight or obesity.
Detailed description
RATIONALE This study will examine the influence of specific beneficial gut bacteria in relation to weight maintenance. The worldwide prevalence of obesity, obesity-associated insulin resistance, and type 2 Diabetes Mellitus (T2DM) has grown dramatically over the last couple of decades; in every region of the world, obesity prevalence has more than tripled since 1975. Even though obesity treatment strategies, such as lifestyle interventions (focussed on diet and/or physical activity) and bariatric surgery have improved, there is extensive variability in responses. In the short term, reducing body weight is relatively easy, for most people. However, maintaining weight loss in the long term is a challenge. Hence, novel strategies to reduce these pandemics and support weight maintenance are strongly warranted.
The gut microbiome has emerged as an important regulator of host energy metabolism, thereby contributing to the etiology of obesity and obesity-related insulin resistance. However, scientific evidence is mainly derived from animal experiments and association studies, and support for causality in humans using mechanistic studies is limited. The influence of a newly identified bacterium, A. muciniphila. has been shown to be associated with a healthy intestine, and its abundance is inversely correlated to several disease states amongst others obesity and insulin resistance. However, the growth requirements of live A. muciniphila as well as its oxygen sensitivity(12) rendered this bacterium unsuitable for human investigations or putative therapeutic opportunities. Therefore, pasteurization, a mild heat inactivation method (30 min at 70 degrees Celsius), and its impact on diet-induced metabolic disorders in mice were investigated. Unexpectedly, this method of inactivation did not abolish the effect of A. muciniphila but even exacerbated its beneficial impacts. In mice, daily administration of pasteurized A. muciniphila alleviates diet-induced obesity. Moreover, a randomized, double-blind, placebo-controlled proof-of-concept study in overweight/obese insulin-resistant adults showed that the daily supplementation with pasteurized A. muciniphila for 12 weeks improved several metabolic parameters such as insulin sensitivity, insulinemia, plasma total cholesterol, as well as relevant blood markers for liver dysfunction and inflammation independently from any caloric restriction or modification of the physical activity. The investigators hypothesize that pasteurized A. muciniphila will be superior to placebo intervention in maintaining body weight after a low caloric diet in participants with overweight or obesity.
OBJECTIVES
- To investigate the effects of pasteurized A. muciniphila on the maintenance of body weight after a phase of weight loss.
- To investigate the effects of pasteurized A. muciniphila on body composition and body fat distribution, glucose homeostasis and insulin sensitivity, and metabolic health.
- To investigate the effects of pasteurized A. muciniphila on the fecal bacterial composition and functionality, systemic inflammation, and gut barrier function and identify relevant biomarkers.
STUDY DESIGN The proposed study is a 32-week double-blind placebo-controlled randomized trial in 108 healthy overweight/ obese (BMI ≥ 28 kg/m2 < 40 kg/m2) Dutch adults, aged 20-70 years. All participants will follow a commercially-prepared low-calorie diet, with 15-20 energy % from fat, 35-40 energy % from protein, and 45-50 energy % from carbohydrates for a period of 8 weeks, to lose 8% of their body weight. In addition to these prepared meals, participants will be allowed limited consumption of specific low-calorie vegetables. Participants will be randomized to either the placebo or the intervention group following the weight-loss period. The weight loss phase will be followed by a 24-week supplementation placebo or active ingredient and a weight maintenance period. Prior to, as well as during both phases of the study participants will receive regular weigh-ins (weeks 0, 1, 4, 8, 16, 24, and 32) and counseling from a registered dietician. In addition to measuring changes in weight and physical measurements, participants will fill in questionnaires, and provide blood and fecal samples at weeks 0, 8, and 32.
QUALITY ASSURANCE Study activities will be carried out by qualified trained personnel, following standard operating procedures (SOP's). All research activities, including data entry and SOP compliance, will be monitored by an independent monitoring board, Clinical trial center Maastricht (CTCM). Data will be analyzed and handled according to the data management and statistical analysis plan.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A double-blind, placebo-controlled randomised intervention study
| Arm | Type | Receives |
|---|---|---|
| Akkermansia muciniphila (A. muciniphila) | Experimental | Dietary Supplement: Akkermansia muciniphilaAfter an 8-week low caloric diet (LCD, ~800kcal), participants who have successfully lost 8% of their body weight who are randomized to the intervention group, will receive pasteurized A. muciniphila. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboAfter an 8-week low caloric diet (LCD, ~800kcal), participants who have successfully lost 8% of their body weight who are randomized to the control group, will receive a placebo. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- BMI ≥ 28 kg/m2 < 40 kg/m2
- Weight stable for at least 3 months (± 2 kg).
Key exclusion criteria (15 listed)
- Type 2 diabetes mellitus (fasting plasma glucose ≥ 7.0 mmol/L)
- Gastroenterological diseases
- Surgery on the gastrointestinal tract (ex.Bariatric surgery)
- Cardiovascular diseases, cancer, liver or kidney malfunction, a disease with a life expectancy of < 5 years;
- Alcohol (>15 standard drinks per week) or drug abuse
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 |
|---|---|---|
| Akkermansia muciniphilaDuring the weight management period (weeks 8 to 32), the pasteurized A. muciniphila product will be orally consumed in water at least 15 min before breakfast for a period of 6 months (24 weeks) capsules. It appears as a white homogenous powder. . | Dietary supplement | Akkermansia muciniphila (A. muciniphila) |
| PlaceboDuring the weight management period (weeks 8 to 32), the placebo product will be orally consumed in water at least 15 min before breakfast for a period of 6 months (24 weeks). It appears as a white homogenous powder. | Dietary supplement | Placebo |
Primary outcome
Body weight
Time frame: 6 months
Changes in body weight following the initial weight loss period will be monitored over the weight maintenance period.
20 secondary outcomes
Body composition
Time frame: 8 months
Body fat distribution
Time frame: 8 months
Glucose metabolism
Time frame: 8 months
Insulin sensitivity
Time frame: 8 months
Lipid profile
Time frame: 8 months
Adipose tissue activity
Time frame: 8 months
Gut barrier function
Time frame: 8 months
Psychological well-being - mental health
Time frame: 8 months
Psychological well-being - sleep quality
Time frame: 8 months
Psychological well-being - stress
Time frame: 8 months
Psychological well-being - General
Time frame: 8 months
Gastrointestinal symptoms - bowel movements
Time frame: 8 months
Gastrointestinal symptoms
Time frame: 8 months
Heart rate
Time frame: 8 months
Blood pressure
Time frame: 8 months
Renal function
Time frame: 8 months
Liver function
Time frame: 8 months
Inflammation
Time frame: 8 months
Microbiota
Time frame: 8 months
Short chain fatty acid production
Time frame: 8 months
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 27 Nov 2023.
- Derived from this study: PubMed 42120725Mount S, Canfora EE, Jocken JW, Umanets A, Hul G, Coenjaerds M, Aldaz Laquidain P, Adriaens ME, Holst JJ, Jardon KM, Segers A, Suenaert P, de Vos WM, Blaak EE. Pasteurized Akkermansia muciniphila MucT for weight loss maintenance in people with overweight and obesity: a controlled randomized trial. Nat Med. 2026 Jun;32(6):2107-2116. doi: 10.1038/s41591-026-04394-7. Epub 2026 May 13.
- Individual participant dataSharing planned: Undecided. After completing the study, the generated data will be shared pseudo-anonymized (participant code, but no private data of the participants will be shared) with the subsiding party A-Mansia Biotech. There are no restrictions with respect to the publication of the data. Both positive and negative results of the studies will be made public, preferably in peer-reviewed international scientific journals, according to the Central Committee on Research involving Human Subjects (CCMO) statement of publication policy. The authorship of the article shall be determined with consideration based on the contribution to the set-up and execution of the study and active participation in publication. Further, this study will be registered in a public trial registry before the first volunteer will be recruited.
Related trials for Obesity
RecruitingPhase 3
Vibegron for ENergy Thinking and Resilience in Aging
Obesity
Not yet recruitingObservational study
Evaluation of the Clinical Spectrum of Diabetes and Obesity in Youth and Adults
Obesity, Diabetes
RecruitingObservational study
Two-Year Weight Loss With GLP-1 Medications Compared With Sleeve Gastrectomy in Adults With Obesity
Obesity & Overweight
Active, not recruitingObservational study
Non-Invasive MASLD Diagnosis & T2D Remission Biomarkers
MASLD, T2DM (Type 2 Diabetes Mellitus)
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Akkermansia muciniphila in people with Obesity and Microtia, run by Maastricht University Medical Center at 1 site in Netherlands.
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 2 inclusion and 15 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 27 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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?
Body weight (time frame: 6 months). 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 NCT05417360, which also lists 1 linked publication.
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 27 Nov 2023.