Type 1 diabetes Type 1 diabetes
Conditions
Interventions
Group 1. The people in this group will receive the bacterial strain D. piger once daily.Group 2. The people in this group will receive a placebo, which looks the same as the real treatment, once daily
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a participant must meet all of the following criteria:- Males or females, age >18 years- A diagnosis of type 1 diabetes, with duration of >5 years, with minimally one of anti-GAD65, IA-2, ZnT8 autoantibodies present assessed at diagnosis or routine visits at Diabeter Centrum.- Evidence of remaining residual beta cell function with detectable UCPCR (>0.01 nmol/mmol C-peptide/creatinine ratio) and/or fasting plasma C-peptide >0.2 mmol/L.- BMI 18-30 kg/m2
Exclusion criteria
Exclusion criteria: A potential participant who meets any of the following criteria will be excluded from participation in this study:- 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 onderzoek- 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To establish the effect of oral probiotic D. piger supplementation on:Systemic inflammation and intestinal inflammation/permeability, assessed by plasma cytokines levels, and markers of intestinal permeability and intestinal inflammation;Residual beta cell function, assessed by C-peptide AUC during mixed meal tolerance test and/or post meal urine C-peptide/creatinine ratio levels. | — |
Secondary
| Measure | Time frame |
|---|---|
| To establish the effect of oral probiotic D. piger supplementation on:Glucose variability: HbA1c, continuous glucose monitoring (CGM) metrics (time in range, time above range, time below range, glucose variability) Immune cell phenotypes and frequency (FACS of PBMC)Fecal microbiome composition (using 16s rRNA sequencing, including strain engraftment of D. piger and plasma metabolites)Gastro-intestinal complaints (assessed by validated questionnaire) | — |
Countries
Netherlands
Contacts
Public ContactM Nieuwdorp
Amsterdam UMC
Outcome results
None listed