Actively Recruiting
Safety and Efficacy of Fecal Microbiota Transplantation on Cognitive Function in T1DM
Led by Second Xiangya Hospital of Central South University · Updated on 2024-07-11
40
Participants Needed
1
Research Sites
192 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Efficacy of Fecal Microbiota Transplantation on Cognitive Function in T1DM
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with type 1 diabetes according to WHO criteria, including insulin dependence from onset and positive islet autoantibodies or diagnosis before age 30
- Aged between 18 and 60 years
- Diabetes duration of 10 years or more
- Glycated hemoglobin levels between 6.5% and 9.0%
You will not qualify if you...
- Use of any hypoglycemic medication other than insulin in the two months before randomization
- Participation in other clinical trials within two months before randomization
- Use of antimicrobial drugs, probiotics, or other gut microbiota regulators within two months before randomization
- Presence of gastrointestinal diseases such as celiac disease, irritable bowel syndrome, or Crohn's disease
- Severe infections or severe heart, liver, kidney diseases, tumors, or other inflammatory or autoimmune diseases
- Pregnant or breastfeeding women, or women planning pregnancy during the study
- Severe mental health disorders including schizophrenia, major depression, bipolar disorder, or substance abuse
- Neurological disorders such as Parkinson's disease, epilepsy, multiple sclerosis, traumatic brain injury, or stroke
- Metal implants or contraindications for MRI examinations
- Severe episodes of unconscious hypoglycemia in the past two months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University
Changsha, Hunan, China, 410011
Actively Recruiting
Research Team
X
Xia Li, MD/PHD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here