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New treatment option for Type 1 Diabetes Mellitis
Official title Faecal Autologous Capsule Transplantation for Type 1 Diabetes Mellitus
ClinicalTrials.gov ID: NCT07083882
What this study is testing
What is freezedried autologous encapsulated fecal microbiota transplantation?
freezedried autologous encapsulated fecal microbiota transplantation is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for type 1 diabetes mellitis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- SUMMARY Rationale: The(small) intestinal microbiota composition has been implicated to play an important role in (human) metabolism, as well as autoimmune diseases such as type 1 diabetes mellitus. Faecal microbiota transplantation (FMT) has been shown to significantly alter the microbiota composition, without any serious side-effects.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 12 months
- You might receive a placebo (an inactive treatment) instead of the study drug. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45
You may be able to join if
- Male or female recently diagnosed (\<100 days) with type 1 diabetes mellitus.
- Age:18-45 years
- BMI: 18-30 kg/m2
- Remaining residual beta cell function: detectable plasma C-peptide or urinary C-peptide at inclusion of the study.
You likely can't join if
- Major systemic illness
- (Expected) prolonged comprised immunity (e.g. due to recent cytotoxic chemotherapy or human immunodeficiency virus(HIV) infection with a CD4 count \<...
- History of a severe disease of the digestive tract, such as celiac disease, chronic diarrhoea (≥3 stools/day for \>4 weeks), chronic obstipation (\ 3...
- Illicit drug use (e.g. MDMA/amphetamine/cocaine/heroin/GHB) in the past three months or use during the study period.
- Use of \>21 units of alcohol per week on average in the past three months.
- Pregnancy or breast feeding.
See the full eligibility criteria
- Male or female recently diagnosed (\<100 days) with type 1 diabetes mellitus.
- Age:18-45 years
- BMI: 18-30 kg/m2
- Remaining residual beta cell function: detectable plasma C-peptide or urinary C-peptide at inclusion of the study.
- Major systemic illness
- (Expected) prolonged comprised immunity (e.g. due to recent cytotoxic chemotherapy or human immunodeficiency virus(HIV) infection with a CD4 count \< 240/mm3).
- History of a severe disease of the digestive tract, such as celiac disease, chronic diarrhoea (≥3 stools/day for \>4 weeks), chronic obstipation (\ 3 months) or Inflammatory Bowel Disease (IBD).
- Illicit drug use (e.g. MDMA/amphetamine/cocaine/heroin/GHB) in the past three months or use during the study period.
- Use of \>21 units of alcohol per week on average in the past three months.
- Pregnancy or breast feeding.
- Inability to provide informed consent.
The study team makes the final eligibility decision.
Where it's taking place
- Amsterdam, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 45 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amsterdam, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.