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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Diabeter Centrum Amsterdam
  Amsterdam, Netherlands Recruiting

Study contacts

• Study coordinator: Nordin MJ Hanssen, MD PhD
• Email: n.m.j.hanssen@amsterdamumc.nl
• Phone: 020 566 9111

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.