Daily capsules of your own freeze-dried gut bacteria to help preserve insulin-producing cells in recent type 1 diabetes

Faecal Autologous Capsule Transplantation for Type 1 Diabetes Mellitus

This trial tests whether taking daily capsules made from your own freeze-dried stool for six months can help preserve remaining insulin-producing beta cells and improve blood sugar control in adults recently diagnosed with type 1 diabetes.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 110 (estimated)
• Ages: 18 Years to 45 Years
• Sex: All
• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Amsterdam)
• Trial ID: NCT07083882 on ClinicalTrials.gov

What this trial studies

This is a single-centre, double-blind, placebo-controlled Phase 2 trial in which adults recently diagnosed with type 1 diabetes will be randomized 1:2 to receive either placebo capsules or capsules containing their own lyophilized fecal microbiota taken daily for six months. The primary outcome is preservation of residual beta cell function measured by C-peptide release during a mixed-meal test (AUC0-120 min) at baseline, 6 months, and 12 months, with additional at-home urinary C-peptide monitoring. Secondary outcomes include measures of glycaemic control (glucose, HbA1c, time-in-range from continuous monitoring), insulin dose requirements, urine microalbumin, questionnaires on GI symptoms and hypoglycaemia, and dietary records. The trial uses validated randomization stratified by sex and placebo matching capsules without microbial content to maintain blinding.

Who should consider this trial

Good fit: Ideal candidates are adults 18–45 years old, recently diagnosed with type 1 diabetes (within 100 days), with a BMI of 18–30 kg/m2 and detectable residual C-peptide, who can provide informed consent and attend follow-up visits in Amsterdam.

Not a fit: Patients with long-standing type 1 diabetes who lack residual beta cell function, those with major gastrointestinal disease, compromised immunity, pregnancy or breastfeeding, or recent illicit drug or heavy alcohol use are unlikely to benefit or are excluded.

Why it matters

Potential benefit: If successful, this approach could slow loss of insulin-producing beta cells, improve glycaemic control, and reduce future insulin requirements for people with recent-onset type 1 diabetes.

How similar studies have performed: Small proof-of-principle and safety studies, including multiple autologous infusions and an initial encapsulated-autologous pilot, reported feasibility and signals of preserved C-peptide up to one year, but larger placebo-controlled confirmation is lacking.

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.

Where this trial is running

Amsterdam

• Diabeter Centrum Amsterdam — Amsterdam, Netherlands (Recruiting)

Study contacts

• Study coordinator: Nordin MJ Hanssen, MD PhD

Conditions Type 1 Diabetes Mellitis; Type 1 Diabetes; Fecal Microbiota Therapy; microbiome; type 1 diabetes; microbiota transplant