*Fecal Microbiota Transplantation to Preserve Residual Beta Cell Function In Patients With Newly-Diagnosed Type 1 Diabetes Mellitus: The FMT-Preserve-DM1-trial*
Phase 2
Recruiting
- Conditions
- juveline diabetesType 1 diabetes10018424
- Registration Number
- NL-OMON54931
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 34
Inclusion Criteria
Inclusion criteria
• Patients with <6 weeks type 1 diabetes
• Aged 18-65 years
• BMI 18-30 kg/m2
• Male/females
• No concomitant medication except insulin
Exclusion Criteria
• Inability to provide written informed consent
• Evidence for absent residual beta cel 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 <p>Residual beta cell function<br /><br>Residual beta cell function will be measured by stimulated C-peptide response<br /><br>upon mixed-meal tolerance (MMTT) area under thecurve (AUC0-120min) at 0, 2, 6,<br /><br>9 and 12 months, using a 2 hour (-10, 0, 15, 30, 45, 60, 90, 120 min) mixed<br /><br>meal (MMT) test at 6ml per kg body weight (max 360 ml per MMT of Sustacal Boost<br /><br>Nutritional Drink, Nestle HS, Switzerland: 33% carbohydrates, 57%fat and 15%<br /><br>protein). An AUC0-120 of plasma C-peptide upon the Boost mixed meal tolerance<br /><br>test (MMTT)) is then calculated.</p><br>
- Secondary Outcome Measures
Name Time Method