betacell function gut microbiota type 1 diabetes mellitus
Conditions
Interventions
after bowel lavage with macrogol, patients will be treated by small intestinal
infusion via a duodenal tube of a microbial solution derived from an allogenic
(healthy donor n=17) or autologous (own)
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: newly diagnosed ( 0.2 mmol/l and/or >1.2 ng/mL after MMT), fasting glucose 10-13 mmol/l and positive anti-GAD and/or anti-IA-2 titer concentrations.
Exclusion criteria
Exclusion criteria: Use of concomitant medication including PPI and antibiotics past three months, smoking, (expected) prolonged compromised immunity (due to recent cytotoxic chemotherapy or HIV infection with a CD4 count
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the primary endpoint is betacell insulin secretion capacity: (beta cell function as assessed by mixed meal test) at 0,2,6,9 and 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secundary endpoint is changes in Immunologic parameters : FACS on periferal leukocyte subsets (change cytokine/Tr1/nTreg/Th2/Th17 subset population), cellular islet autoimmunity (CD4 and CD8) in relation to mucosa innate en adaptive immunity (CCR4, CXCR3,CXCL10) and antiGAD /c-peptide plasma concentrations at 0,2,4,6,9 en 12 months. Our tertiary endpoint is changes in small intestinal (at baseline and after 6 months) and fecal gutmicrobiota composition at 0,2, 6, 9 and 12 months. Moreover, our fourth endpoint pertains changes in plasma biochemistry (HbA1c levels) and urine (microalbuminuria) at 0, 2, 6, 9 and 12 months. Finally, our fifth endpoint is intestinal integrity: Changes in small intestinal genes (ILLUMINA array en occluding expression) at baseline and at 6 months. | — |
Countries
Netherlands
Outcome results
None listed