Fecal Microbiota Transplantation to Restore Residual Beta Cell Function In Patients With Long- Duration Type 1 Diabetes Mellitus
Recruiting
- Conditions
- type 1 diabetes
- Registration Number
- NL-OMON27205
- Lead Sponsor
- Amsterdam UMC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 34
Inclusion Criteria
• Patients with >5 years type 1 diabetes
• Aged 18-65 years
• BMI 18-30 kg/m2
• Male/females
• No concomitant medication besides exogenous insulin
Exclusion Criteria
Inability to provide written informed consent
• Evidence for absent residual beta cel function (undetectable C-peptide in urine)
• Antibiotics use in the last 3 months and proton-pump inhibitor use
• Evidence for compromised immunity
• Second auto-immune disease (i.e. coeliac disease, hyper- or hypothyroidism,
inflammatory bowel disease)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method residual beta cell function (measured with a mixed meal test ) in relation to gut microbiota composition changes at 6 months before treatments (run-in), at baseline, and at 6 and 12 months.
- Secondary Outcome Measures
Name Time Method reduction in autoimmunity markers including FACS on peripheral blood lymphocyte subsets (change Th17 (CD4+IL-17+) and T-regs (CD4+CD25+ FoxP3+) and T-cell exhaustion at these timepoints. Finally, plasma metabolites are determined