Does FMT improve residual beta cell function in longstanding DM1
ID
Bron
Verkorte titel
Aandoening
type 1 diabetes
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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.
Achtergrond van het onderzoek
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
Doel van het onderzoek
Does FMT improve residual beta cell function in longstanding DM1
Onderzoeksopzet
6 months before treatments (run-in) as well as at baseline, and at 6 and 12 months after start of FMT treatment.
Onderzoeksproduct en/of interventie
multiple fecal transplantations from either donors (DM1 subjects with highly preserved beta cell function) or autologous feces
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
• Patients with >5 years type 1 diabetes
• Aged 18-65 years
• BMI 18-30 kg/m2
• Male/females
• No concomitant medication besides exogenous insulin
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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)
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL9153 |
| Ander register | METC AMC : 2020_225 |