Fecal Microbiota Transplantation to Preserve Residual Beta Cell Function In Patients With Newly Diagnosed Type 1 Diabetes Mellitus
Recruiting
- Conditions
- type 1 diabetes
- Registration Number
- NL-OMON26193
- Lead Sponsor
- DFN/DON grant
- Brief Summary
n/a
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 34
Inclusion Criteria
patients with <6 weeks of new onset type 1 diabetes mellitus and detectable C-peptide levels (aged 18-65 years, BMI 18-30 kg/m2, male/females, no concomitant medication).
Exclusion Criteria
•Inability to provide written informed consent
•Evidence for absent residual betacel function (undetectable C-peptide)
•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 Effect on residual beta cell function as measured by stimulated C-peptide response upon mixed-meal tolerance (Boost) area under the curve (AUC0-120min) using a 2 hour mixed meal (MMT) test at 0, 6, 9 and 12 months.
- Secondary Outcome Measures
Name Time Method