Encapsulated Faecal Microbiota Transplantation to Preserve Residual Beta Cell Function in Type 1 Diabetes Mellitus

NCT05323162 | Unknown

• 1 other identifier: NL79666.018.21
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

In this single arm pilot study it will be investigated whether encapsulated autologous fecal microbiota transplantation may be used to halt the decline in residual beta cell function in individuals with recent onset Type 1 diabetes mellitus.

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

• Preservation of residual beta cell insulin secretion capacity

  assessed by maximal C-peptide release (residual beta cell function) upon an MMT, AUC0-120 (mmol/ll x min) will be calculated.

  at -3, 0, 3 and 6 months.

Secondary Outcomes (6)

• HbA1c

  At -3, 0, 3 and 6 months.

• Glycaemic control

  At -3, 0, 3 and 6 months.

• Fecal microbiota composition

  At -3, 0, 3 and 6 months.

• Small intestinal microbiota composition

  Fecal: At -3, 0, 3 and 6 months. Duodenal biopsy: 0 and 3 months

• Questionnaire

  At -3, 0, 3 and 6 months.

Study Arms (1)

Encapsulated autologous fecal microbiota transplantation

EXPERIMENTAL

Encapsulated own microbiota to be transplanted from large- to small intestine by oral ingestion

Other: encapsulated autologous fecal microbiota transplantation

Interventions

encapsulated autologous fecal microbiota transplantation OTHER

Individuals will recieve encapsulated freezedried own fecal microbiota to potentially extingish auto-immunity directed against the residual beta cell fraction

Encapsulated autologous fecal microbiota transplantation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• In order to be eligible to participate in this study, a subject must meet all of the following criteria:
• Male or female recently diagnosed (0.5-3.5 years) with type 1 diabetes mellitus.
• Age: 18-65 years
• BMI: 18-30 kg/m2

You may not qualify if:

• A potential subject who meets any of the following criteria will be excluded from participation in this study:
• History or symptoms of other autoimmune disease (e.g. hypo- or hyperthyroidism, rheumatoid arthritis).
• (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), Irritable Bowel Syndrome (IBS) (according to Rome IV criteria) or Inflammatory Bowel Disease (IBD).
• Use of antibiotics, antacid drugs or proton pump inhibitors in the past 3 months or during the study period.
• Use of pro-/prebiotics in the past three months or during the study period.
• Smoking or 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

• Nordin Hanssen: lead

Study Sites (1)

Academisch Medisch Centrum

Amsterdam, Please Select, 1105 AZ, 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

Fuhri Snethlage, MD

CONTACT

020 566 9111; c.m.fuhrisnethlage@amsterdamumc.nl

Hanssen, MD PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Internist-endocrinologist, Principial investigator

Model Details: Encapsulated autologous fecal microbiota transplantation.

Study Record Dates

• First Submitted: March 17, 2022
• First Posted: April 12, 2022
• Study Start: April 1, 2022
• Primary Completion: April 1, 2023
• Study Completion: October 1, 2023
• Last Updated: April 12, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)