Faecal Autologous Capsule Transplantation for Type 1 Diabetes Mellitus

NCT07083882 | Recruiting Phase 2

• 1 other identifier: METC2025.0067
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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. It was recently demonstrated that multiple infusions of own faeces(autologous) preserved residual beta cell function up to one year after start of the FMT. In a proof-of-principle study it was found that encapsulated autologous FMT provides a safe and feasible option for prolonged treatment on a daily basis, which might stabilize the beta-cell destruction. These exciting findings are potentially transformative for clinical practice and deserve replication in a larger placebo-controlled trial. Objective: confirm the efficacy and feasibility of daily ingested encapsulated freeze-dried autologous (own)faecal matter on the preservation of residual beta cell function as assessed by C-peptide release upon amixed meal test (MMT) in recently diagnosed type 1 diabetes mellitus (T1D). Study design: double-blind placebo-controlled study Study population: n=110, recently diagnosed (\<100 days of diagnosis) patients with T1D, aged 18-45 years, BMI 18-30 kg/m2, male/female. Intervention: After inclusion and randomisation individuals will receive for 6 months either placebo or freeze-dried autologous encapsulated FMT in a 1:2 ratio. Subsequently, participants with be followed for 6 months whether beta cell preservation was durable after cessation of treatment. Main study parameters/endpoints: The primary endpoint is long-term preservation of beta cell insulin secretion capacity as assessed by stimulated C-peptide AUC0-120minresponse upon MMT (at0, 6 and 12months).The secondary endpoint pertains to changes in post-meal urinary C-peptide levels, plasma biochemistry (HbA1c levels),glucose time-in-range and subsequentexogenous insulin dose use at 0, 6 and 12months. Nature and extent of the burden and risks associated with participation,benefit and group relatedness: This study is considered a low-risk study, 3MMTs will be performed, for which 70 ml of blood samples will be drawn each visit. As of today, no severe adverse events as result of FMT have been reported in this centre and in the ENCAPSULATE trial investigating the feasibility and safety of this approach participants only reported some minor and transient constipation. In addition, the use of autologous faeces comes with a lower(absent)risk for transmitting any unknown pathogens compared to an allogenic FMT. As there currently is no widely applied therapy to preserve beta cell function in type 1 diabetes, encapsulated autologous FMT can have a potential benefit for the participants.

Conditions

Type 1 Diabetes Mellitis; Type 1 Diabetes (T1D); Fecal Microbiota Therapy (FMT)

Keywords

microbiome; type 1 diabetes; microbiota transplant

Outcome Measures

Primary Outcomes (1)

• Preservation of residual beta cell insulin secretion capacity

  measured by plasma C-peptide in mixed meal and 2hour post meal urine sample

  At baseline, at 6 months upon completion of treatment and at 12 months after intiation of treatment

Secondary Outcomes (4)

• Hba1c

  At baseline, at 6 months upon completion of treatment and at 12 months after intiation of treatment

• Continuous glucose monitoring

  At baseline, at 6 months upon completion of treatment and at 12 months after intiation of treatment

• albuminuria

  At baseline, at 6 months upon completion of treatment and at 12 months after intiation of treatment

• exogenous insulin dose

  At baseline, at 6 months upon completion of treatment and at 12 months after intiation of treatment

Other Outcomes (1)

• GI-Symptoms Rating Scale (GSRS)

  At baseline, at 6 months upon completion of treatment and at 12 months after intiation of treatment

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Other: placebo matching capsule without microbial content

Encapsulated autologous fecal microbiota transplantation

EXPERIMENTAL

Biological: freezedried autologous encapsulated fecal microbiota transplantation

Interventions

freezedried autologous encapsulated fecal microbiota transplantation BIOLOGICAL

The freezedried autologous encapsulated microbiota transplantation increases the exposure of the small intestine to the microbiota residing in the colon. Prior evidence was found that this has strong immunomodulatory effects leading to potential preservation of beta cell function in type 1 diabetes.

Encapsulated autologous fecal microbiota transplantation

placebo matching capsule without microbial content OTHER

this is the matching placebo capsule that looks from the outside identical to the actual treatment but does not contain the fecal microbiota.

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female recently diagnosed (\<100 days) with type 1 diabetes mellitus.
• Age:18-45 years
• BMI: 18-30 kg/m2

You may not qualify 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 \< 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 (\<2 defecations/week for \>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.

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead
• Diabeter Centrum Amsterdam: collaborator

Study Sites (1)

Diabeter Centrum Amsterdam

Amsterdam, Netherlands

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Nordin MJ Hanssen, MD PhD

CONTACT

020 566 9111; n.m.j.hanssen@amsterdamumc.nl

Max Nieuwdorp, MD PhD

CONTACT

020 566 9111

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 11, 2025
• First Posted: July 24, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2029
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)