Ireland
--:--IST
Recruiting Not applicable

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

NCT07585994 · tracked via the Priya Life Science Netherlands tracker
Phase
Not applicable
Started
2026-05
Last updated
2026-05-14

Condition(s) studied

Type 1 Diabetes Mellitus

Investigational drug(s) / intervention(s)

Probiotic dietary supplementPlacebo

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Absence of a large bowel (ie colostomy) * Evidence for comprised immunity (HIV infection, chemotherapy, other autoimmune diseases, systemic anti-inflammatory therapy) * History of cardiovascular disaeses (CVD) events * Hepatic enzymes\>2.5 higher than the upper limit of normal range, determined during MARVEL visits/routine visits * Kidney failure (eGFR \<15ml.min/1.73m2), dialysis, kidney transplantation, * Inability or unwillingness to donate feces or urine. * Smoking or illicit drug use (e.g. MDMA/amphetamine/cocaine/heroin/GHB) in the past three months or use during the study period. * Alcohol abuse (equal or above 21 units per week) * Inability or unwillingness to provide informed consent.

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)

FacilityCityRegionStatus
Diabeter Centrum Amsterdam Amsterdam Netherlands Recruiting
Amsterdam UMC Amsterdam Netherlands Recruiting
Official registry record

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