← Back to all trials
Recruiting
NCT05622123
BetaFIT Study: Beta Cell Imaging After Faecal mIcrobiota Transplantation
Conditions: Type 1 Diabetes
Sex: All
Ages: 18 Years – N/A
Phase: PHASE2
Enrollment: 20
Sponsor: Radboud University Medical Center
Location: Netherlands
Summary
The main goal is to investigate whether beta cell mass is correlated to beta cell function after autologous faecal microbial transplantation (FMT) in patients with newly diagnosed type 1 diabetes
Eligibility Criteria
Inclusion Criteria:Previously participated in ENCAPSULATE-DM1 or FMT preserve-DM1 trialType 1 diabetes with the diagnosis being made in the last 4.5 yearsPresence of at least one autoantibody associated with type 1 diabetes (anti-GAD-65, anti-IA2, islet cell antibodies, insulin autoantibodies)Age ≥ 18 yearsBMI 18-30 kg/m2Insulin useExclusion Criteria:Inability to provide written informed consentOther medication use than insulinSmokingEvidence of compromised immunityPresence of a second autoimmune disease (other than type 1 diabetes); e.g.
celiac disease, hyper- or hypothyroidism, inflammatory bowel disease.
Vitiligo is allowed.Pregnancy or the wish to become pregnant within 1 month after the studyBreastfeedingLiver disease defined as aspartate aminotransferase or alanine aminotransferase level of more than three times the upper limit of normal rangeRenal disease defined as MDRD < 40 ml/min/1.73
m²
Source: ClinicalTrials.gov (NCT05622123). StuddyBuddy aggregates publicly available trial information.