Status:
RECRUITING
Safety and Efficacy of Fecal Microbiota Transplantation on Cognitive Function in T1DM
Lead Sponsor:
Second Xiangya Hospital of Central South University
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
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 cognit...
Eligibility Criteria
Inclusion
- 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%.
Exclusion
- 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.
Key Trial Info
Start Date :
April 20 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2027
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06496412
Start Date
April 20 2024
End Date
December 30 2027
Last Update
July 11 2024
Active Locations (1)
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1
Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University
Changsha, Hunan, China, 410011