An interventional study of Fecal Microbial Transplantation and Placebo in Diabetes Mellitus Type 2, Fecal Microbiota Transplantation (FMT) and Oral Glucose Tolerance Test, sponsored by Central Jutland Regional Hospital. Active, not recruiting at 1 site in Denmark. Open to participants aged 18 Years to 67 Years. Per ClinicalTrials.gov, last updated 2026-07-14.
Sponsored by Central Jutland Regional Hospital · Not applicable, Interventional, and Treatment
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.
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.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's planned enrollment of 16 is below the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Central Jutland Regional Hospital is the lead sponsor of 32 studies on the registry; 5 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The participants will receive two rounds of FMT with two weeks between each treatment.
Other: Fecal Microbial Transplantation
Placebo capsules visually identical to FMT capsules
Other: Placebo
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.
Also known as: FMT
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.
Also known as: Placebo capsules
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.
Time frame: At baseline and at week 7
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.
Time frame: At baseline and at week 7
Hemoglobin A1c
Hemoglobin A1c in plasma (in mmol/mol)
Time frame: 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.
Time frame: At baseline and at week 7
Body mass index
Weight (in kilograms), height (in meters) for calculation of BMI
Time frame: At baseline and at week 7
Waist circumference
Waist circumference(in centimeters)
Time frame: 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.
Time frame: At baseline and at week 7
LEAP-2/ghrelin
LEAP-2/ghrelin (arbitrary units, with LEAP-2 and ghrelin in ng/ml)
Time frame: At baseline and at week 7
GLP-1
glukagonlike peptide-1 (in pmol/l)
Time frame: At baseline and at week 7
Interleukin 1-beta
IL1B measured with Multiplex (in pg/ml)
Time frame: At baseline and at week 7
Triglycerides
Measurements of serum triglycerides (in mmol/L)
Time frame: At baseline and at week 7
C-reactive protein
C-reactive protein (mg/L))
Time frame: At baseline and at week 7
Remnant cholesterol
Remnant is calculated from Total, LDL, and HDL-cholesterol (all in mmol/L)
Time frame: At baseline and at week 7
Plan to share: 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
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Data will be available beginning after publication of the primary study results and will remain available for a reasonable period thereafter, subject to continued data governance and ethical approval.
Access criteria: Access to IPD and supporting information will be granted to qualified researchers with a scientifically sound research proposal. Requests will be reviewed by the study investigators. Approved users will receive access to de-identified data relevant to the approved analysis, following execution of a data use agreement. Data will be shared via secure data transfer. Due to the small sample size, full datasets will not be made publicly available.
This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Central Jutland Regional Hospital