Effect of 4 Weeks of Oral Probiotic Desulfovibrio Piger Supplementation on Immunological and Metabolic Parameters in Individuals With Longstanding Type 1 Diabetes
Condition(s) studied
Investigational drug(s) / intervention(s)
Probiotic dietary supplement: Probiotic bacteria D. piger (10\^9 colony forming units (CFU) in 10ml PBS containing 10% glycerol and 10% maltodextrin)
Placebo: Placebo (10ml PBS containing 10% glycerol and 10% maltodextrin)
Study summary
The goal is to establish the effect of oral probiotic Desulfovibrio piger (D. piger) supplementation on immunological and metabolic parameters in individuals with longstanding type 1 diabetes with residual beta cell function. The investigators will perform a double-blind, randomized, placebo-controlled trial in 2x10 participants to measure effects of D. piger on parameters of systemic and intestinal inflammation and residual beta cell function.
Eligibility
Primary outcome measure(s)
- Parameters of systemic and intestinal inflammation — From start treatment to the end of treatment at 4 weeks and washout at 6 weeks.
systemic inflammation determined by measuring plasma CRP, and proinflammatory cytokines (IFNgamma, IFN alpha, TNFalpha) intestinal inflammation assessed by LB, iFABP, zonulin in plasma - Residual beta cell function — From start treatment to the end of treatment at 4 weeks and washout at 6 weeks.
Assessed by C peptide AUC during mixed meal tolerance test and/or post meal urine C-peptide/creatinine ratio levels.
Trial sites (2)
| Facility | City | Region | Status |
|---|---|---|---|
| Diabeter Centrum Amsterdam | Amsterdam | Netherlands | Recruiting |
| Amsterdam UMC | Amsterdam | Netherlands | Recruiting |
More Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) trials in the Netherlands
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07585994 on ClinicalTrials.gov ↗ ← All trials in the Netherlands