Type 1 Diabetes (T1D) Clinical Trials

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Effect of 4 Weeks of Oral Probiotic Desulfovibrio Piger Supplementation on Immunological and Metabolic Parameters in Individuals With Longstanding Type 1 Diabetes

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Males or females, age \>18 years

• A diagnosis of type 1 diabetes, with duration of more than 5 years, with minimally one of antiGAD65, IA2, ZnT8 autoantibodies present assessed at diagnosis or routine visits at Diabeter Centrum.

• Evidence of remaining residual beta cell function with detectable UCPCR (more than 0.01 nmol/mmol C-peptide/creatinine ratio) and or fasting plasma C-peptide more than 0.2 mmol/L.

• BMI 18-30 kg/m2

Locations
Other Locations
Netherlands
Amsterdam UMC
RECRUITING
Amsterdam
Diabeter Centrum Amsterdam
RECRUITING
Amsterdam
Contact Information
Primary
Max Nieuwdorp, Prof. Dr.
m.nieuwdorp@amsterdamumc.nl
+31 20-5669111
Time Frame
Start Date: 2026-05
Estimated Completion Date: 2028-05
Participants
Target number of participants: 20
Treatments
Experimental: Probiotic Desulfovibrio piger
Probiotic bacteria D. piger (10\^9 colony forming units (CFU) in 10ml PBS containing 10% glycerol and 10% maltodextrin)
Placebo_comparator: Placebo
placebo (10ml PBS containing 10% glycerol and 10% maltodextrin)
Related Therapeutic Areas
Sponsors
Leads: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

This content was sourced from clinicaltrials.gov