NCT06496412Recruiting
Safety and Efficacy of Fecal Microbiota Transplantation on Cognitive Function in T1DM
Safety and Efficacy of Fecal Microbiota Transplantation on Cognitive Function in T1DM: a Randomized Controlled, Triple-blind Clinical Study
Source: ClinicalTrials.gov · Last updated 11 Jul 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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. This study is divided into two phases for recruiting participants. The first phase recruits 10 individuals (experimental group: 5, control group: 5), while the second phase recruits 30 individuals (experimental group: 15, control group: 15).The main research objectives are as follows: 1. To observe the difference in cognitive function between the FMT group and the placebo group, with the indicators including cognitive scale scores, changes in brain MRI imaging indicators and brain age at week 24 compared to baseline. 2. To observe the difference in other complications between the FMT group and the placebo group, with the indicators including changes in urinary albumin/creatinine ratio, fundus photography, carotid intima-media thickness, and arterial pulse wave velocity at week 24 compared to baseline. 3. To observe the difference in glycemic control, insulin dosage, insulin resistance, peripheral blood immune cells, gut microbiota, and serum metabolites between the FMT group and the placebo group. 4. To evaluate the safety of FMT.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 25 Jun 2024
- Start date
- 20 Apr 2024
- Primary completion date
- 30 Dec 2026
- Lead sponsor
- Second Xiangya Hospital of Central South University
- Diseases
- Type 1 diabetes
- NCT number
- NCT06496412
What you commit to
- Study type: Interventional
- Planned participants: 40
- From 20 Apr 2024 to the primary completion date, 30 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
- 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.
Other
- Pregnant or lactating women, or women planning pregnancy during the study period.
- Post-implantation of metal materials or contraindications for other MRI examinations.
- Severe episodes of unconscious hypoglycemia within the past two months.
Who the study is looking for
- 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 from disease onset and diabetic ketoacidosis (DKA)/diabetic ketosis (DK) at diagnosis; (iii) positive for at least one of islet autoantibodies for glutamic acid decarboxylase antibody \[GADA\], insulinoma-associated protein 2 antibody \[IA-2A\], and zinc transporter 8 antibody \[ZnT8A\]; or negative for all three islet autoantibodies, but diagnosed before age 30.
- 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%.
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University Coordinator of this site? Confirm its status | Changsha | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.