Actively Recruiting
Effect of 4 Weeks of Oral Probiotic Desulfovibrio Piger Supplementation on Immunological and Metabolic Parameters in Individuals With Longstanding Type 1 Diabetes
Led by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Updated on 2026-05-14
20
Participants Needed
2
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effect of 4 Weeks of Oral Probiotic Desulfovibrio Piger Supplementation on Immunological and Metabolic Parameters in Individuals With Longstanding Type 1 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males or females, age >18 years
- Diagnosis of type 1 diabetes for more than 5 years with at least one of antiGAD65, IA2, or ZnT8 autoantibodies present
- Evidence of remaining residual beta cell function with detectable UCPCR (more than 0.01 nmol/mmol C-peptide/creatinine ratio) or fasting plasma C-peptide more than 0.2 mmol/L
- Body mass index (BMI) between 18 and 30 kg/m2
You will not qualify if you...
- Use of antibiotics or proton-pump inhibitors within the last 3 months before screening or during the study
- Use of other probiotic supplements within the last month before screening or during the study
- History of cholecystectomy
- Untreated gastrointestinal disease, inflammatory bowel disease, or abnormal bowel habits
- Absence of a large bowel (e.g., colostomy)
- Compromised immunity due to HIV, chemotherapy, other autoimmune diseases, or systemic anti-inflammatory therapy
- History of cardiovascular disease events
- Liver enzymes greater than 2.5 times the upper normal limit
- Kidney failure (eGFR <15 ml/min/1.73 m2), dialysis, or kidney transplant
- Inability or unwillingness to donate feces or urine
- Smoking or illicit drug use in the past 3 months or during the study
- Alcohol abuse (21 or more units per week)
- Inability or unwillingness to provide informed consent
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Diabeter Centrum Amsterdam
Amsterdam, Netherlands, 1066 EC
Actively Recruiting
2
Amsterdam UMC
Amsterdam, Netherlands, 1105 AZ
Actively Recruiting
Research Team
M
Max Nieuwdorp, Prof. Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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