Fecal Microbiota Transplantation to Preserve Residual Beta Cell Function In Patients With Newly Diagnosed Type 1 Diabetes Mellitus

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON26193

Enrollment

Registered

2021-05-13

Start date

2021-05-13

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

Interventions

allogenic donor fecal transplantation (from longterm type 1 diabetes mellitus patients with preserved beta cell function) versus placebo

Eligibility

Inclusion criteria

Inclusion criteria: patients with <6 weeks of new onset type 1 diabetes mellitus and detectable C-peptide levels (aged 18-65 years, BMI 18-30 kg/m2, male/females, no concomitant medication).

Exclusion criteria

Exclusion criteria: • Inability to provide written informed consent • Evidence for absent residual betacel function (undetectable C-peptide) • Antibiotics use in the last 3 months and proton-pump inhibitor use • Evidence for compromised immunity • Second auto-immune disease (i.e. coeliac disease, hyper- or hypothyroidism, inflammatory bowel disease)

Design outcomes

Primary

Measure	Time frame
Effect on residual beta cell function as measured by stimulated C-peptide response upon mixed-meal tolerance (Boost) area under the curve (AUC0-120min) using a 2 hour mixed meal (MMT) test at 0, 6, 9 and 12 months.	—

Secondary

Measure	Time frame
Effect on Immunologic whole blood parameters (FACS) including circulating immune cell fractions and specifically measure T-cell exhaustion at 0, 6, 9 and 12 months. Also, we will use RNA seq to measure expression patterns in these cells to pinpoint which immune pathways are differentially expressed at these timepoints. Effect on fecal microbiota composition (sequencing) and plasma and urine metabolites at 0, 6, 9 and 12 months. Effects on the small intestinal microbiota composition as well as (histology) immunological and transcriptome changes in duodenal biopsies taken at 0 and 6 months. Effect on clinical diabetes management( daily exogenous insulin dosage (IE/kg bw) and amount of hypoglycemia events, dietary intake and gastrointestinal complaints using questionaires at 0, 6, 9 and 12 months Effect on glucose variability (HbA1c) as well as FreeStyle data (FSL determined time in range (TIR), hypo- and hyperglycemic episodes )measured with participants continuous glucose monitoring device at 0, 6, 9 and 12 months.	—

Measure

Time frame

Effect on Immunologic whole blood parameters (FACS) including circulating immune cell fractions and specifically measure T-cell exhaustion at 0, 6, 9 and 12 months. Also, we will use RNA seq to measure expression patterns in these cells to pinpoint which immune pathways are differentially expressed at these timepoints. Effect on fecal microbiota composition (sequencing) and plasma and urine metabolites at 0, 6, 9 and 12 months. Effects on the small intestinal microbiota composition as well as (histology) immunological and transcriptome changes in duodenal biopsies taken at 0 and 6 months. Effect on clinical diabetes management( daily exogenous insulin dosage (IE/kg bw) and amount of hypoglycemia events, dietary intake and gastrointestinal complaints using questionaires at 0, 6, 9 and 12 months Effect on glucose variability (HbA1c) as well as FreeStyle data (FSL determined time in range (TIR), hypo- and hyperglycemic episodes )measured with participants continuous glucose monitoring device at 0, 6, 9 and 12 months.

—

Contacts

Public Contactmax nieuwdorp

AMC

m.nieuwdorp@amsterdamumc.nl0031 20 5666612

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)