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ID
Source
Brief title
Health condition
type 1 diabetes
Sponsors and support
Intervention
Outcome measures
Primary outcome
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
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
Background summary
To investigate whether fecal microbial transplantation (FMT) from either allogenic donor
(from type 1 diabetes with a highly preserved beta cell fraction) or autologous (own) donor restores residual beta cell function up until 12 months after intervention in patients with longstanding type 1 diabetes
Study objective
Does FMT improve residual beta cell function in longstanding DM1
Study design
6 months before treatments (run-in) as well as at baseline, and at 6 and 12 months after start of FMT treatment.
Intervention
multiple fecal transplantations from either donors (DM1 subjects with highly preserved beta cell function) or autologous feces
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)
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9153 |
| Other | METC AMC : 2020_225 |