Faecal Autologous Capsule Transplantation for Type 1 Diabetes Mellitus

Launched by ACADEMISCH MEDISCH CENTRUM - UNIVERSITEIT VAN AMSTERDAM (AMC-UVA) · Jul 22, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new way to help people recently diagnosed with type 1 diabetes, a condition where the body stops making insulin properly. Researchers are testing whether taking capsules made from a person’s own freeze-dried stool (called autologous fecal microbiota transplantation or FMT) can help protect the insulin-producing cells in the pancreas. These capsules aim to improve the balance of bacteria in the gut, which might slow down the damage to these important cells and help the body manage blood sugar better.

People eligible for this study are adults aged 18 to 45 who have been diagnosed with type 1 diabetes within the last 100 days and still have some insulin-producing cell function left. During the trial, participants will take either the special stool capsules or a placebo (a harmless inactive capsule) every day for six months, without knowing which they’re taking. The study lasts a total of 12 months, including six months of follow-up after treatment ends. Participants will have regular blood tests and meal tests to check how well their insulin-producing cells are working and monitor their blood sugar control. The study is considered low risk, with only minor side effects like temporary constipation reported so far. This research could offer a new way to help people with type 1 diabetes maintain their insulin production longer, which current treatments don’t provide.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Male or female recently diagnosed (\<100 days) with type 1 diabetes mellitus.
• • 2. Age:18-45 years
• • 3. BMI: 18-30 kg/m2
• • 4. Remaining residual beta cell function: detectable plasma C-peptide or urinary C-peptide at inclusion of the study.
• Exclusion Criteria:
• • 1. Major systemic illness
• • 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) or Inflammatory Bowel Disease (IBD).
• • 4. Illicit drug use (e.g. MDMA/amphetamine/cocaine/heroin/GHB) in the past three months or use during the study period.
• • 5. Use of \>21 units of alcohol per week on average in the past three months.
• • 6. Pregnancy or breast feeding.
• • 7. Inability to provide informed consent.