Safety and Efficacy of Fecal Microbiota Transplantation on Cognitive Function in T1DM
NCT ID: NCT06496412
Last Updated: 2024-07-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2024-04-20
2027-12-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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.
fecal microbiota transplantation
Take fecal microbiota capsules.
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.
Placebo
Take placebo capsules.
Interventions
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fecal microbiota transplantation
Take fecal microbiota capsules.
Placebo
Take placebo capsules.
Eligibility Criteria
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Inclusion Criteria
2. Age between 18 and 60 years, with a diabetes duration of 10 years or more
3. Glycated hemoglobin levels ranging from 6.5% to 9.0%.
Exclusion Criteria
2. Participation in other clinical trials within the two months prior to randomization.
3. Use of antimicrobial drugs, probiotics, intestinal microbiota regulators, and other drugs with significant impact on gut microbiota within the two months prior to randomization.
4. Gastrointestinal diseases: celiac disease, irritable bowel syndrome, Crohn's disease, etc.
5. Severe infections, severe heart, liver, kidney diseases, tumors, and other inflammatory or autoimmune diseases.
6. Pregnant or lactating women, or women planning pregnancy during the study period.
7. Severe mental health disorders such as schizophrenia, major depression, bipolar disorder, alcohol or substance abuse, etc.
8. Neurological disorders such as Parkinson's disease, progressive supranuclear palsy, epilepsy, multiple sclerosis, traumatic brain injury, stroke, etc.
9. Post-implantation of metal materials or contraindications for other MRI examinations.
10. Severe episodes of unconscious hypoglycemia within the past two months.
18 Years
60 Years
ALL
No
Sponsors
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Second Xiangya Hospital of Central South University
OTHER
Responsible Party
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Xia Li
Professor, Department of Endocrinology, Institute of of Metabolism and Endocrinology, National Clinical Research Center for Metabolic Diseases, Second Xiangya Hospital of Central South University
Principal Investigators
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Xia Li, MD/PHD
Role: PRINCIPAL_INVESTIGATOR
The Second Xiangya Hospital, Central South University
Locations
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Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University
Changsha, Hunan, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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T1D cognitive impairment FMT
Identifier Type: -
Identifier Source: org_study_id
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