Fecal Microbiota Transplantation Intervention on Microbiota Composition and Insulin Sensitivity in Diabetes
New Diabetes Trial Tests Gut Bacteria for Better Blood Sugar Control
Plain English Summary
Fecal Microbiota Transplantation Intervention on Microbiota Composition and Insulin Sensitivity in Diabetes is a Not Applicable clinical trial sponsored by Central Jutland Regional Hospital studying Diabetes Mellitus Type 2, Fecal Microbiota Transplantation (FMT), Oral Glucose Tolerance Test, Continuous Glucose Monitoring. This trial is testing if transplanting gut bacteria from healthy donors can improve blood sugar control in people with type 2 diabetes. It is for adults diagnosed with type 2 diabetes who are not currently using insulin or certain other diabetes medications. Participants will receive either a capsule containing gut bacteria or a placebo capsule, and their blood sugar and gut bacteria will be monitored. Standard diabetes management and lifestyle changes are the current alternatives. The trial aims to enroll 16 participants.
Official 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.
Who Can Participate
Here is what you need to know about eligibility for this trial. You can join if you have type 2 diabetes. You cannot join if you are taking insulin or sulfonylurea drugs, have had recent antibiotic or probiotic use, or have certain heart, lung, or kidney conditions. You also cannot join if you have active gastrointestinal diseases, liver or gallbladder issues, or are pregnant. Age is not specified, but general health and specific medical conditions are key factors. This trial is studying Diabetes Mellitus Type 2, Fecal Microbiota Transplantation (FMT), Oral Glucose Tolerance Test, Continuous Glucose Monitoring, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
Insulin sensitivity measures how well your body's cells respond to insulin to take up sugar from your blood, and the trial will see if the treatment improves this response. The specific primary outcome measures are: Insulin sensitivity (At baseline and at week 7). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial explores a novel approach using gut bacteria to address a key challenge in managing type 2 diabetes, aiming to improve how the body uses sugar. This research targets Diabetes Mellitus Type 2, Fecal Microbiota Transplantation (FMT), Oral Glucose Tolerance Test, Continuous Glucose Monitoring, where improved treatment options are needed.
Investor Insight
This trial targets the large market of type 2 diabetes patients, exploring a microbiome-based therapy which is a growing area of interest, suggesting potential for innovative treatments if successful.
Is This Trial Right for Me?
Ask your doctor if this trial is right for you, especially regarding your current diabetes management and overall health. Participation involves taking capsules (either the treatment or placebo) and regular monitoring of your blood sugar and gut health over several weeks. You will need to avoid certain medications and intense exercise during the study period. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: QUADRUPLE
- Enrollment: 16 participants
Interventions
- OTHER: Fecal Microbial Transplantation — 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
- OTHER: Placebo — 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.
Primary Outcomes
- Insulin sensitivity (At baseline and at week 7)
Secondary Outcomes
- Time-in-range (At baseline and at week 7)
- Hemoglobin A1c (At baseline and at week 7)
- Glucose management indicator (At baseline and at week 7)
- Body mass index (At baseline and at week 7)
- Waist circumference (At baseline and at week 7)
Full Eligibility Criteria
Inclusion Criteria: * Has type 2 diabetes Exclusion Criteria: * 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 * 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
- Medical Diagnostics Center, Regional Hospital Central Jutland (HEM), Viborg, Denmark
Frequently Asked Questions
What is clinical trial NCT07375797?
NCT07375797 is a Not Applicable INTERVENTIONAL study titled "Fecal Microbiota Transplantation Intervention on Microbiota Composition and Insulin Sensitivity in Diabetes." It is currently recruiting and is sponsored by Central Jutland Regional Hospital. The trial targets enrollment of 16 participants.
What conditions does NCT07375797 study?
This trial investigates treatments for Diabetes Mellitus Type 2, Fecal Microbiota Transplantation (FMT), Oral Glucose Tolerance Test, Continuous Glucose Monitoring. The primary condition under study is Diabetes Mellitus Type 2.
What treatments are being tested in NCT07375797?
The interventions being studied include: Fecal Microbial Transplantation (OTHER), Placebo (OTHER). 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
What does Not Applicable mean for NCT07375797?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT07375797?
This trial is currently "Recruiting." It started on 2026-02-05. The estimated completion date is 2026-09.
Who is sponsoring NCT07375797?
NCT07375797 is sponsored by Central Jutland Regional Hospital. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07375797?
The trial aims to enroll 16 participants. The trial is currently recruiting and accepting new participants.
How is NCT07375797 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs quadruple masking. Masking means some participants and/or investigators do not know which treatment group a participant is in, which helps reduce bias.
What are the primary outcomes being measured in NCT07375797?
The primary outcome measures are: Insulin sensitivity (At baseline and at week 7). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT07375797 being conducted?
This trial is being conducted at 1 site, including Viborg (Denmark).
Where can I find official information about NCT07375797?
The official record for NCT07375797 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07375797. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07375797 testing in simple terms?
This trial is testing if transplanting gut bacteria from healthy donors can improve blood sugar control in people with type 2 diabetes. It is for adults diagnosed with type 2 diabetes who are not currently using insulin or certain other diabetes medications.
Why is this trial significant?
This trial explores a novel approach using gut bacteria to address a key challenge in managing type 2 diabetes, aiming to improve how the body uses sugar.
What are the potential risks of participating in NCT07375797?
Potential risks include common side effects associated with gut bacteria changes, such as temporary digestive upset. As this is a new approach, unknown long-term effects are a possibility. The study involves medical procedures like blood draws and capsule intake, which carry their own minor risks. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07375797?
Ask your doctor if this trial is right for you, especially regarding your current diabetes management and overall health. Participation involves taking capsules (either the treatment or placebo) and regular monitoring of your blood sugar and gut health over several weeks. You will need to avoid certain medications and intense exercise during the study period. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07375797 signal from an investment perspective?
This trial targets the large market of type 2 diabetes patients, exploring a microbiome-based therapy which is a growing area of interest, suggesting potential for innovative treatments if successful. This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participants will receive either a capsule containing gut bacteria or a placebo capsule, and their blood sugar and gut bacteria will be monitored. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.