Safety and Efficacy of Fecal Microbiota Transplantation on Cognitive Function in T1DM: a Randomized Controlled, Triple-blind Clinical Study

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• 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%.

Locations
Other Locations
China
Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University
RECRUITING
Changsha
Contact Information
Primary
Xia Li, MD/PHD
lixia2014@vip.163.com
+86 13974885753
Time Frame
Start Date: 2024-04-20
Estimated Completion Date: 2027-12-30
Participants
Target number of participants: 40
Treatments
Experimental: fecal microbiota transplantation
On the basis of baseline medication, high-dose fecal microbiota transplantation (FMT) will be administered, with subjects taking 50 fecal microbiota capsules. Subsequently, maintenance doses will be administered at week 2, 4, 8, 12, and 20, with 10 capsules taken each time. Fasting is required 4 hours before and 1 hour after capsule ingestion, and subjects are instructed to maintain a stable diet and physical activity pattern throughout the 24-week study period. Capsules will be transported on ice and warmed for 10 minutes at 37°C before FMT administration.
Placebo_comparator: placebo
Different from the experimental group, the control group will receive placebo capsules that have the same appearance as the fecal microbiota capsules, while other procedures remain the same as those in the experimental group.
Related Therapeutic Areas
Sponsors
Leads: Second Xiangya Hospital of Central South University

This content was sourced from clinicaltrials.gov