The DIMID1-trial: Effect of Donor Intestinal Microbiota Infusion on residual betacell function in patients with recently diagnosed Diabetes mellitus type 1.

We propose to test the effect of multiple infusions of one healthy donor (=allogenic) compared to multipele infusion of own feces (=autologous) on residual betacell function, immunologic status (in periferal blood and mucosa) and gut microbiota composition both in small intestinal (biopsies) and fecal samples. Using this protocol we might be able to disentangle potential causality of intestinal bacteria in the pathophysiology of type 1 diabetes mellitus.

To investigate whether microbial transplantation from either allogenic (healthy) or autologous (own) donor, administered through a small intestinal tube, has beneficial effects on immune status, betacell function (Cpeptide secretion upon a mixed meal test (MMT) in recently diagnosed type 1 diabetes mellitus. Moreover, we aim to see which small (intestinal biopsies) and large intestinal (fecal samples) microbiota are associated with these clinical changes.

At baseline, 2, 6, 9 and 12 months.

We will compare the effect of multiple allogenic (using feces of thorouhgly screened healthy donor) versus autologous (=using own feces) fecal transplantation on preservation of beta cell insulin secretion capacity and normalisation of immunological tone (Thelper cell subsets in blood) in subjects recently diagnosed with type 1 diabetes mellitus. Fecal transplantation (using fresh morning fecal sample) will be performed by introduction of a duodenal tube (either by gastroduodenoscopy or by Cortrak device assisted electromagnetic positioning) , followed by total bowel-lavage with cetomacrogol and subsequent of infusion of processed fecal sample. beta cell insulin secretion capacity will be tested by mixed meal test and immunological tone (Thelper cell subsets in blood) by FACS analysis.