effect of Donor Intestinal Microbiota Infusion on residual betacell function in patients with recently diagnosed Diabetes mellitus type 1 ; the DIMID1-trial

Completed

• Conditions: betacell function; gut microbiota; type 1 diabetes mellitus; 10018424

• Registration Number: NL-OMON41670
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 51

Inclusion Criteria

newly diagnosed (< 6 weeks) patients with type 1 diabetes (n<=34, aged 18-39 years, BMI 20-25 kg/m2, male/females, no concomitant medication use except insulin, plasma C-peptide > 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

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 < 240).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>the primary endpoint is betacell insulin secretion capacity: (beta cell<br /><br>function as assessed by mixed meal test) at 0,2,6,9 and 12 months. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secundary endpoint is changes in Immunologic parameters : FACS on periferal<br /><br>leukocyte subsets (change cytokine/Tr1/nTreg/Th2/Th17 subset population),<br /><br>cellular islet autoimmunity (CD4 and CD8) in relation to mucosa innate en<br /><br>adaptive immunity (CCR4, CXCR3,CXCL10) and antiGAD /c-peptide plasma<br /><br>concentrations at 0,2,4,6,9 en 12 months. Our tertiary endpoint is changes in<br /><br>small intestinal (at baseline and after 6 months) and fecal gutmicrobiota<br /><br>composition at 0,2, 6, 9 and 12 months. Moreover, our fourth endpoint pertains<br /><br>changes in plasma biochemistry (HbA1c levels) and urine (microalbuminuria) at<br /><br>0, 2, 6, 9 and 12 months. Finally, our fifth endpoint is intestinal integrity:<br /><br>Changes in small intestinal genes (ILLUMINA array en occluding expression) at<br /><br>baseline and at 6 months.</p><br>