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

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

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.

Conditions2

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