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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

About this trial

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 criteria

Qualifiers

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

Disqualifiers

Use of antibiotics or proton-pump inhibitors within the last three months before screening or during study period

Use of other probiotic supplementation within the last month before screening or during study period

A history of cholecystectomy

Overt untreated gastrointestinal disease, inflammatory bowel disease or abnormal bowel habits

Trial design

Treatments tested in this trial

  • Probiotic dietary supplement
  • Placebo

Treatment groups

20 Participants
are divided into 2 treatment groups