Diabetes Mellitus Type 2FeMICNCT07375797
Fecal Microbiota Transplantation Intervention on Microbiota Composition and Insulin Sensitivity in Diabetes
A study testing Fecal Microbial Transplantation in people with Diabetes Mellitus Type 2 and Fecal Microbiota Transplantation (FMT), run by Central Jutland Regional Hospital at 1 site in Denmark.
Trial summary
The purpose of the trial is to investigate the effect of fecal microbiota transplantation versus placebo on glycemic metabolism and gut microbiota composition in people with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 67 years
- Conditions the study is for
- Diabetes Mellitus Type 2, Fecal Microbiota Transplantation (FMT), Oral Glucose Tolerance Test
- What is being tested?
- Fecal Microbial Transplantation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteDenmark
- Study dates
- 5 Feb 2026to 15 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 67 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has type 2 diabetes
Who cannot join
- Treatment with insulin or sulfonylurea drugs.
- Treatment with antibiotics, probiotics/lactic acids cultures, or proton pump inhibitors within the last three months.
- Regular exercise and/or more than 150 minutes of moderate intensity exercise or 75 minutes of high intensity exercise per week, within the last 6 months.
- Diagnosed with unstable angina, recent (within the last 8 weeks) myocardial infarction, any disease in the coronal arteries, decompensated heart failure (NYHA II-IV), severe valvular disease, lung disease
- Hypertension which is not currently under medical control (systolic pressure >200 mmHg and/or diastolic pressure >130 mmHg)
- Bariatric surgery within the previous year or a plan to undergo bariatric surgery during the study period
Show all 15Show fewer
- Self-reported drug or alcohol abuse
- Patients preparing for or currently experiencing pregnancy during the study period
- Disease of the liver and/or gallbladder, including parenchymal liver disease, liver cirrhosis, pancreatitis, autoimmune liver disease
- All diseases of the gastrointestinal tract, which can lead to or increase the risk of defects in the mucosal membrane. This includes chronic diarrhea, inflammatory bowel disease, malabsorption, malnutrition, recent infection with clostridium difficile, primary sclerosing cholangitis, radiation induced enteritis, chemotherapy induced diarrhea, hematological diseases
- Reactive hypoglycemia
- Anemia and other diseases of the bone marrow
- Kidney diseases, including moderate albuminuria and other disturbances in the electrolytes balance
- Food allergies, allergies towards catheters (i.e. Venflon) and other instruments used in the study.
- Other condition deeming individuals inappropriate for recruitment according to the investigators or sponsor
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Medical Diagnostics Center, Regional Hospital Central Jutland (HEM)
Viborg, 8800
About this study
The purpose of the trial is to investigate the effect of fecal microbiota transplantation versus placebo on glycemic metabolism and gut microbiota composition in people with type 2 diabetes.
Read the detailed description
People with type 2 diabetes have been shown to exhibit an altered composition of the gut microbiota, including a reduced abundance of butyrate-producing bacteria. Although the underlying mechanisms are not fully elucidated, alterations in gut microbiota composition may be important in the pathogenesis of type 2 diabetes and in metabolic regulation. Fecal microbiota transplantation (FMT) from lean donors has been shown to transiently improve insulin sensitivity and increase the abundance of butyrate-producing bacteria in individuals with metabolic syndrome.
A double-blinded, randomized, placebo-controlled trial will be conducted to investigate the effects of FMT on glycaemic metabolism and gut microbiota composition in individuals with type 2 diabetes. A total of 16 participants will be randomly assigned to one of two groups, receiving either FMT or placebo.
Glycaemic metabolism will be assessed at baseline and again at week 7 post-intervention using three complementary measures: the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR), an oral glucose tolerance test (OGTT) for the Matsuda index, and continuous glucose monitoring (CGM). In addition, stool samples will be collected before and after the intervention to evaluate changes in gut microbiota composition following FMT, for example using 16S rRNA gene sequencing.
- Conditions
- Diabetes Mellitus Type 2, Fecal Microbiota Transplantation (FMT), Oral Glucose Tolerance Test, Continuous Glucose Monitoring
- Being tested
- Fecal Microbial Transplantation, Placebo
- Keywords
- Fecal Microbiota Transplantation, FMT, Insulin Sensitivity, Type II Diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal Microbial TransplantationOther
Also called FMT
The capsules consists of approximately 50 grams of donor feces. This is cryopreserved, homogenized and dispensed into double-coated, acid resistant enterocapsules. A single treatment includes approximately 25 capsules.
The fecal material is obtained from healthy donors, recruited from thoroughly screened healthy blood donors and processed in compliance with the European Tissue and Cells Directive. Further, the donors lipid status and HbA1c is screened, ensuring only metabolically healthy donors are included.
PlaceboOther
Also called Placebo capsules
The placebo products consists of the same capsules as FMT. The content of the capsules is produced from a suspension of glycerol, saline and food coloring. The number of placebo capsules will correspond to the amount of FMT capsules.
The placebo capsules will be identical in visual appearance.
| Study group | Role | What they receive |
|---|---|---|
| Fecal Microbiota Transplantation | Experimental | The participants will receive two rounds of FMT with two weeks between each treatment. Receives: Other: Fecal Microbial Transplantation |
| Placebo | Placebo comparator | Placebo capsules visually identical to FMT capsules Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin sensitivity
Insulin sensitivity assessed by the Matsuda index, calculated from plasma glucose (in mmol/L) and serum insulin(in pmol/L) concentrations measured repeatedly during a standardized oral glucose tolerance test at baseline and after 7 weeks.
Measured: At baseline and at week 7
Secondary outcomes (6)
Time-in-range
Percentage of time with interstitial glucose values between 3.9 and 10.0 mmol/L, derived from continuous glucose monitoring data collected over a 10-day period at baseline and during the final two weeks of the intervention.
Measured: At baseline and at week 7
Hemoglobin A1c
Hemoglobin A1c in plasma (in mmol/mol)
Measured: At baseline and at week 7
Glucose management indicator
Glucose management indicator (GMI) calculated from mean interstitial glucose values derived from continuous glucose monitoring data collected over a 10-day period at baseline and during the final two weeks of the intervention.
Measured: At baseline and at week 7
Body mass index
Weight (in kilograms), height (in meters) for calculation of BMI
Measured: At baseline and at week 7
Waist circumference
Waist circumference(in centimeters)
Measured: At baseline and at week 7
Microbiome analysis
Fecal samples will be collected and analyzed to characterize the gut microbiome and its changes in response to the intervention. Analyses may include 16S rRNA gene sequencing and/or other molecular or biochemical methods to assess microbial composition, diversity, and selected functional features. The specific analytical methods will be defined prior to analysis.
Measured: At baseline and at week 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start5 Feb 2026
- Primary completion25 Jun 2026
- Study completion15 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Type 2Studies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Jutland Regional Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, University of Aarhus
- Responsible party
- Principal investigator, Henrik Holm Thomsen, Central Jutland Regional Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07375797
- Sponsor's protocol ID
- 1-10-72-140-23
- Acronym
- FeMIC
- Status last verified
- Apr 2026
- First submitted
- 12 Jan 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be shared upon reasonable request to the corresponding author. Data will be de-identified where possible and made available to qualified researchers for scientific purposes. Due to the small sample size and risk of re-identification, data will not be deposited in a public repository
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal Microbiota Transplantation Intervention on Microbiota Composition and Insulin Sensitivity in Diabetes
- ClinicalTrials.gov ID
- NCT07375797
- Acronym / sponsor ID
- FeMIC / 1-10-72-140-23
- Conditions
- Diabetes Mellitus Type 2, Fecal Microbiota Transplantation (FMT), Oral Glucose Tolerance Test, Continuous Glucose Monitoring
- Keywords
- Fecal Microbiota Transplantation, FMT, Insulin Sensitivity, Type II Diabetes
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Central Jutland Regional HospitalUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, University of Aarhus
- Study start
- 5 Feb 2026 (actual)
- Primary completion
- 25 Jun 2026 (actual)
- Study completion
- 15 Oct 2026 (estimated)
- First posted
- 29 Jan 2026 (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 the trial is to investigate the effect of fecal microbiota transplantation versus placebo on glycemic metabolism and gut microbiota composition in people with type 2 diabetes.
Detailed description
People with type 2 diabetes have been shown to exhibit an altered composition of the gut microbiota, including a reduced abundance of butyrate-producing bacteria. Although the underlying mechanisms are not fully elucidated, alterations in gut microbiota composition may be important in the pathogenesis of type 2 diabetes and in metabolic regulation. Fecal microbiota transplantation (FMT) from lean donors has been shown to transiently improve insulin sensitivity and increase the abundance of butyrate-producing bacteria in individuals with metabolic syndrome.
A double-blinded, randomized, placebo-controlled trial will be conducted to investigate the effects of FMT on glycaemic metabolism and gut microbiota composition in individuals with type 2 diabetes. A total of 16 participants will be randomly assigned to one of two groups, receiving either FMT or placebo.
Glycaemic metabolism will be assessed at baseline and again at week 7 post-intervention using three complementary measures: the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR), an oral glucose tolerance test (OGTT) for the Matsuda index, and continuous glucose monitoring (CGM). In addition, stool samples will be collected before and after the intervention to evaluate changes in gut microbiota composition following FMT, for example using 16S rRNA gene sequencing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fecal Microbiota Transplantation | Experimental | Other: Fecal Microbial TransplantationThe participants will receive two rounds of FMT with two weeks between each treatment. |
| Placebo | Placebo comparator | Other: PlaceboPlacebo capsules visually identical to FMT capsules |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Has type 2 diabetes
Key exclusion criteria (15 listed)
- Treatment with insulin or sulfonylurea drugs.
- Treatment with antibiotics, probiotics/lactic acids cultures, or proton pump inhibitors within the last three months.
- Regular exercise and/or more than 150 minutes of moderate intensity exercise or 75 minutes of high intensity exercise per week, within the last 6 months.
- Diagnosed with unstable angina, recent (within the last 8 weeks) myocardial infarction, any disease in the coronal arteries, decompensated heart failure (NYHA II-IV), severe valvular disease, lung disease
- Hypertension which is not currently under medical control (systolic pressure >200 mmHg and/or diastolic pressure >130 mmHg)
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 |
|---|---|---|
| Fecal Microbial TransplantationAlso: FMTThe capsules consists of approximately 50 grams of donor feces. This is cryopreserved, homogenized and dispensed into double-coated, acid resistant enterocapsules. A single treatment includes approximately 25 capsules. The fecal material is obtained from healthy donors, recruited from thoroughly screened healthy blood donors and processed in compliance with the European Tissue and Cells Directive. Further, the donors lipid status and HbA1c is screened, ensuring only metabolically healthy donors are included. | Other | Fecal Microbiota Transplantation |
| PlaceboAlso: Placebo capsulesThe placebo products consists of the same capsules as FMT. The content of the capsules is produced from a suspension of glycerol, saline and food coloring. The number of placebo capsules will correspond to the amount of FMT capsules. The placebo capsules will be identical in visual appearance. | Other | Placebo |
Primary outcome
Insulin sensitivity
Time frame: At baseline and at week 7
Insulin sensitivity assessed by the Matsuda index, calculated from plasma glucose (in mmol/L) and serum insulin(in pmol/L) concentrations measured repeatedly during a standardized oral glucose tolerance test at baseline and after 7 weeks.
6 secondary outcomes
Time-in-range
Time frame: At baseline and at week 7
Hemoglobin A1c
Time frame: At baseline and at week 7
Glucose management indicator
Time frame: At baseline and at week 7
Body mass index
Time frame: At baseline and at week 7
Waist circumference
Time frame: At baseline and at week 7
Microbiome analysis
Time frame: At baseline and at week 7
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Centre for Faecal Microbiota Transplantation - CEFTALink provided by the sponsor.
- Individual participant dataSharing planned: Yes. IPD will be shared upon reasonable request to the corresponding author. Data will be de-identified where possible and made available to qualified researchers for scientific purposes. Due to the small sample size and risk of re-identification, data will not be deposited in a public repository
Related trials for Diabetes Mellitus Type 2
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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 Fecal Microbial Transplantation in people with Diabetes Mellitus Type 2 and Fecal Microbiota Transplantation (FMT), run by Central Jutland Regional Hospital at 1 site in Denmark.
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 1 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: under way, not looking for participants, as of the sponsor's last update on 14 Jul 2026. 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 Denmark. 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?
This study is still under way. Results are not available in the source record yet.
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 (time frame: At baseline and at week 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jul 2026.