Effect of 4 Weeks of Oral Probiotic Desulfovibrio Piger Supplementation on Immunological and Metabolic Parameters in Individuals With Longstanding Type 1 Diabetes
NCT07585994 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2026-05-14
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.
Conditions
- Type 1 Diabetes Mellitus
Interventions
- DIETARY_SUPPLEMENT
-
Probiotic dietary supplement
Probiotic bacteria D. piger (10\^9 colony forming units (CFU) in 10ml PBS containing 10% glycerol and 10% maltodextrin)
- DIETARY_SUPPLEMENT
-
Placebo
Placebo (10ml PBS containing 10% glycerol and 10% maltodextrin)
Sponsors & Collaborators
-
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
lead OTHER
Principal Investigators
-
Max Nieuwdorp, Prof. Dr. · Amsterdam UMC
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-05-31
- Primary Completion
- 2028-05-31
- Completion
- 2028-05-31
Countries
- Netherlands
Study Locations
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