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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON29482

Enrollment

Registered

2012-11-12

Start date

2013-01-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

type 1 diabetes mellitus

Interventions

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 secr

Eligibility

Inclusion criteria

Inclusion criteria: Newly diagnosed ( 0.2 mmol/l and/or >1.2 ng/mL after MMT), male/females, will be recruited by poster advertisement.

Exclusion criteria

Exclusion criteria: Subjects 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.

Design outcomes

Primary

Measure	Time frame
Preservation of residual betacell insulin secretion capacity/beta cell function as assessed by mixed meal test (MMT) at 0, 6 and 12 months.	—

Secondary

Measure	Time frame
1. 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.	—

Measure

Time frame

1. 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.

—

Contacts

Public ContactM. Nieuwdorp

AFDELING INWENDIGE GENEESKUNDE AMC MEIBERGDREEF 9, KAMER F4.159.2

m.nieuwdorp@amc.uva.nl+31 (0)20 5666612

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)