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NCT07585994Recruiting

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

Source: ClinicalTrials.gov · Last updated 14 May 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
20 (estimated)
First submitted
5 May 2026
Start date
1 May 2026
Primary completion date
31 May 2028
Lead sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
NCT number
NCT07585994

What you commit to

  • Study type: Interventional
  • Planned participants: 20
  • From 1 May 2026 to the primary completion date, 31 May 2028
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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
  • Smoking or illicit drug use (e.g. MDMA/amphetamine/cocaine/heroin/GHB) in the past three months or use during the study period.

Other illness

  • A history of cholecystectomy
  • Overt untreated gastrointestinal disease, inflammatory bowel disease or abnormal bowel habits
  • Evidence for comprised immunity (HIV infection, chemotherapy, other autoimmune diseases, systemic anti-inflammatory therapy)
  • History of cardiovascular disaeses (CVD) events

Lab values

  • Kidney failure (eGFR \<15ml.min/1.73m2), dialysis, kidney transplantation,

Other

  • Absence of a large bowel (ie colostomy)
  • Hepatic enzymes\>2.5 higher than the upper limit of normal range, determined during MARVEL visits/routine visits
  • Inability or unwillingness to donate feces or urine.
  • Alcohol abuse (equal or above 21 units per week)
  • Inability or unwillingness to provide informed consent.

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Amsterdam UMC
Coordinator of this site? Confirm its status
AmsterdamNetherlandsRecruiting
Diabeter Centrum Amsterdam
Coordinator of this site? Confirm its status
AmsterdamNetherlandsRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.