Ignite Creation Date:
2024-07-17 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06496412
Status:
RECRUITING
Last Update Posted:
2024-07-11
First Post:
2024-06-25
Brief Title:
Safety and Efficacy of Fecal Microbiota Transplantation on Cognitive Function in T1DM
Sponsor:
Second Xiangya Hospital of Central South University
Organization:
Second Xiangya Hospital of Central South University
Study Overview
Official Title:
Safety and Efficacy of Fecal Microbiota Transplantation on Cognitive Function in T1DM a Randomized Controlled Triple-blind Clinical Study
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a prospective single-center parallel-design11 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 15The 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 albumincreatinine 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
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 albumincreatinine 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None