Fecal Microbiota Transplantation to Restore Residual Beta Cell Function In Patients With Long- Duration Type 1 Diabetes Mellitus

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON27205

Enrollment

Registered

2020-12-22

Start date

2020-12-22

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

type 1 diabetes

Interventions

multiple fecal transplantations from either donors (DM1 subjects with highly preserved beta cell function) or autologous feces

Eligibility

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Contacts

Public Contactmax nieuwdorp

Amsterdam UMC

m.nieuwdorp@amsterdamumc.nl0031 20 5666612

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)