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van CCT (UK)

van CCT (UK)

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

- candidate number13733
- NTR NumberNTR3697
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR12-nov-2012
- Secondary IDs201/295 METC AMC
- Public TitleThe DIMID1-trial: Effect of Donor Intestinal Microbiota Infusion on residual betacell function in patients with recently diagnosed Diabetes mellitus type 1.
- Scientific TitleThe DIMID1-trial: Effect of Donor Intestinal Microbiota Infusion on residual betacell function in patients with recently diagnosed Diabetes mellitus type 1.
- hypothesisTo 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.
- Healt Condition(s) or Problem(s) studiedDiabetes Mellitus Type 1 (DM type I)
- Inclusion criteriaNewly diagnosed (< 6 weeks) patients with type 1 diabetes (n=34, aged 18-30 years, BMI 18-25 kg/m2, with still residual betacell function (as indicated by plasma C-peptide > 0.2 mmol/l and/or >1.2 ng/mL after MMT), male/females, will be recruited by poster advertisement.
- Exclusion criteriaSubjects with diagnosis or symptoms of another autoimmune disease (eg hypo- or hyperthyroidism, coeliakie, rheumatoid arthritis or inflammatory bowel disease like Crohn/Colitis Ulcerosa) are not able to participate. Smoking, (expected) prolonged compromised immunity (due to recent cytotoxic chemotherapy or HIV infection with a CD4 count < 240) as well as antibiotics use in the last 3 months and PPI use is seen as an exclusion criterium.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2013
- planned closingdate1-jan-2017
- Target number of participants34
- InterventionsWe 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.
- Primary outcomePreservation of residual betacell insulin secretion capacity/beta cell function as assessed by mixed meal test (MMT) at 0, 6 and 12 months.
- Secondary outcome1. Immunologic parameters: Changes in immunology based on FACS of periferal leukocyte subsets (changes in Tr1/nTreg/Th2/ Th17/NKT/TCRγδ subsets, islet autoimmunity (CD4 and CD8) ) in relation to mucosa innate en adaptive immunity (CCR4, CXCR3,CXCL10) as well as plasma markers of autoimmunity ( antiGAD/IA2/c-peptide plasma concentrations) at 0, 2, 6, 9 and 12 months;
2. Intestinal microbiota: Changes in small intestinal (at baseline and 6 months) and fecal gut microbiota composition at 0, 2, 6, 9 and 12 months;
3. Glycemic control: Changes in plasma biochemistry (HbA1c),urine (microalbuminuria) and subsequent exogenous insulin dose use at 0, 2, 6, 9 and 12 months;
4. Intestinal epithelial integrity: Changes in small intestinal epithelial genes (ILLUMINA array) at baseline and 6 months.
- TimepointsAt baseline, 2, 6, 9 and 12 months.
- Trial web siteN/A
- statusstopped: trial finished
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC), Amsterdam
- PublicationsN/A
- Brief summaryWe 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.
- Main changes (audit trail)
- RECORD12-nov-2012 - 2-jun-2018

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