Encapsulated Faecal Microbiota Transplantation to Preserve Residual Beta Cell Function in Patients with Recently-Diagnosed Type 1 Diabetes Mellitus
- Conditions
- Juveline diabetestype 1 diabetes mellitus10012653
- Registration Number
- NL-OMON50429
- Lead Sponsor
- niversitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 10
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
1. Male or female recently diagnosed (0.5-3.5 years) with type 1 diabetes
mellitus.
2. Age: 18-65 years
3. BMI: 18-30 kg/m2
4. Remaining (detectable) residual beta cell function: detectable urinary or
plasma C- peptide at inclusion of the study.
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
1. History or symptoms of other autoimmune disease (e.g. hypo- or
hyperthyroidism, rheumatoid arthritis).
2. (Expected) prolonged comprised immunity (e.g. due to recent cytotoxic
chemotherapy or human immunodeficiency virus (HIV) infection with a CD4 count <
240/mm3).
3. History of a severe disease of the digestive tract, such as celiac disease,
chronic diarrhoea (>=3 stools/day for >4 weeks), chronic obstipation (<2
defecations/week for >3 months), Irritable Bowel Syndrome (IBS) (according to
Rome IV criteria) or Inflammatory Bowel Disease (IBD).
4. Use of antibiotics, antacid drugs or proton pump inhibitors in the past 3
months or during the study period.
5. Use of pro-/prebiotics in the past three months or during the study period.
6. Smoking or illicit drug use (e.g. MDMA/amphetamine/cocaine/heroin/GHB) in
the past three months or use during the study period.
7. Use of >21 units of alcohol per week on average in the past three months
8. Pregnancy or breast feeding
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Preservation of residual beta cell function (insulin secretion capacity)<br /><br>Residual beta cell function will be determined as stimulated C-peptide release<br /><br>during two hours (AUC0-120min) upon an MMT. The MMT will be performed during<br /><br>every visit at -3, 0, 3 and 6 months. C-peptide concentrations will be<br /><br>presented as pmol/ml. </p><br>
- Secondary Outcome Measures
Name Time Method