Effect of 4 Weeks of Desulfovibrio piger Probiotic on Immunological and Metabolic Parameters in Longstanding Type 1 Diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Researchers will conduct a double-blind, randomized, placebo-controlled study in 20 adults with longstanding type 1 diabetes and residual beta cell function. Participants will receive either Desulfovibrio piger or placebo daily for four weeks, followed by a two-week washout. Primary outcomes compare changes in systemic and intestinal inflammatory markers and residual beta cell function between groups at four weeks, with an additional assessment after washout. Secondary endpoints include glucose variability by CGM, fecal microbiome and strain engraftment, immune cell profiles, and GI symptom questionnaires at baseline, week 4, and week 6. The study uses a 6-week timeline to explore potential short-term and lingering effects of the probiotic.

Why it matters

Who can join: the full rules

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.

Where it's running

• Diabeter Centrum Amsterdam
  Amsterdam, Netherlands Recruiting
• Amsterdam UMC
  Amsterdam, Netherlands Recruiting

Study contacts

• Principal investigator: Max Nieuwdorp, Prof. Dr. — Amsterdam UMC
• Study coordinator: Max Nieuwdorp, Prof. Dr.
• Email: m.nieuwdorp@amsterdamumc.nl
• Phone: +31 20-5669111

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.