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Tests treatment safety and results for Type 1 Diabetes
Official title Safety and Efficacy of Fecal Microbiota Transplantation on Cognitive Function in T1DM
ClinicalTrials.gov ID: NCT06496412
What this study is testing
What is fecal microbiota transplantation?
fecal microbiota transplantation is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for type 1 diabetes.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is a prospective, single-center, parallel-design,1:1 randomized controlled trial with triple blinding. It aims to investigate the effects of fecal microbiota transplantation (FMT) on cognitive function in patients with long-term type 1 diabetes (T1D), as well as its effects on other complications, glycemic control, insulin dosage, insulin resistance, peripheral blood immune cells, serum metabolites, and safety.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- According to the definition of type 1 diabetes mellitus (T1DM) by the World Health Organization (WHO), the diagnostic criteria are as follows: (i)...
- Age between 18 and 60 years, with a diabetes duration of 10 years or more
- Glycated hemoglobin levels ranging from 6.5% to 9.0%.
You likely can't join if
- Use of any hypoglycemic medication other than insulin in the two months prior to randomization.
- Participation in other clinical trials within the two months prior to randomization.
- Use of antimicrobial drugs, probiotics, intestinal microbiota regulators, and other drugs with significant impact on gut microbiota within the two...
- Gastrointestinal diseases: celiac disease, irritable bowel syndrome, Crohn's disease, etc.
- Severe infections, severe heart, liver, kidney diseases, tumors, and other inflammatory or autoimmune diseases.
- Pregnant or lactating women, or women planning pregnancy during the study period.
See the full eligibility criteria
- According to the definition of type 1 diabetes mellitus (T1DM) by the World Health Organization (WHO), the diagnostic criteria are as follows: (i) clinically diagnosed as T1D by endocrinologists; (ii) insulin dependence...
- Age between 18 and 60 years, with a diabetes duration of 10 years or more
- Glycated hemoglobin levels ranging from 6.5% to 9.0%.
- Use of any hypoglycemic medication other than insulin in the two months prior to randomization.
- Participation in other clinical trials within the two months prior to randomization.
- Use of antimicrobial drugs, probiotics, intestinal microbiota regulators, and other drugs with significant impact on gut microbiota within the two months prior to randomization.
- Gastrointestinal diseases: celiac disease, irritable bowel syndrome, Crohn's disease, etc.
- Severe infections, severe heart, liver, kidney diseases, tumors, and other inflammatory or autoimmune diseases.
- Pregnant or lactating women, or women planning pregnancy during the study period.
- Severe mental health disorders such as schizophrenia, major depression, bipolar disorder, alcohol or substance abuse, etc.
- Neurological disorders such as Parkinson's disease, progressive supranuclear palsy, epilepsy, multiple sclerosis, traumatic brain injury, stroke, etc.
- Post-implantation of metal materials or contraindications for other MRI examinations.
- Severe episodes of unconscious hypoglycemia within the past two months.
The study team makes the final eligibility decision.
Where it's taking place
- Changsha, Hunan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Changsha, Hunan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.