Type 1 DiabetesENCAPSULATENCT05323162
Encapsulated Faecal Microbiota Transplantation to Preserve Residual Beta Cell Function in Type 1 Diabetes Mellitus
A study testing encapsulated autologous fecal microbiota transplantation in people with Type 1 Diabetes, run by Nordin Hanssen at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- encapsulated autologous fecal microbiota transplantation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteNetherlands
- Study dates
- Apr 2022to Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Remaining residual beta cell function: detectable plasma C-peptide or urinary Cpeptide at inclusion of the study
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Academisch Medisch Centrum
Amsterdam, Please Select, 1105 AZ
Hanssen, MD, n.m.j.hanssen@amsterdamumc.nl
About this study
Official title: Encapsulated Faecal Microbiota Transplantation to Preserve Residual Beta Cell Function in Patients With Recently-Diagnosed Type 1 Diabetes Mellitus
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.
Read the detailed description
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. Encapsulated autologous FMT provides a safe and feasible option for prolonged treatment on a daily basis, which might stabilize the beta-cell destruction and extend or even bring back the honeymoon period (wherein individuals with recently diagnosed T1D remain wellregulated with minimal doses of insulin).
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 a mixed meal test (MMT) in recently diagnosed type 1 diabetes mellitus (T1D).
Study design: Open label study Study population: Recently diagnosed (0.5-3.5 years of diagnosis) patients with T1D (n=10, aged 18-65 years, BMI 18-30 kg/m2, male/female).
Intervention: After inclusion in the study and a run-in period of 3 months, stools of the participants will be collected and processed into freeze-dried faecal microbiota capsules, which will be ingested daily for 3 months. Participants will be followed for 9 months after inclusion.
Main study parameters/endpoints: The primary endpoint is long-term preservation of beta cell insulin secretion capacity as assessed by stimulated C-peptide AUC0-120min response upon MMT (at -3, 0, 3 and 6 months). The secondary endpoint pertains to changes in plasma biochemistry (HbA1c levels), glucose time-in-range (Freestyle Libre) and subsequent exogenous insulin dose use at -3, 0, 3 and 6 months. The tertiary endpoint is changes in faecal gut microbiota composition at -3, 0, 3 and 6 months, as well as small intestinal microbiota (duodenal biopsy via gastroscopy at 0 and 3 months).
The fourth endpoint is dietary intake and urinary and plasma metabolites at -3, 0, 3 and 6 months.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: This study is considered an intermediate risk study, mainly due to the duodenal biopsies via gastroscopy at 0 and 3 months. 4 MMTs will be performed, for which 70 ml of blood samples will be drawn each visit. The patient will complete several questionnaires, keep track of a food diary and collect urine and faeces prior to study visits. At the study visits BMI and blood pressure will be measured. As of today no adverse events as result of FMT have been reported in this centre. In addition, the use of autologous faeces comes with a lower risk for transmitting any unknown pathogens compared to an allogenic FMT from a lean healthy donor. Moreover, the encapsulated FMT provides an less invasive, well tolerated alternative to the traditional fresh FMT via nasoduodenal tube. As there currently is no 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
- Being tested
- encapsulated autologous fecal microbiota transplantation
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
encapsulated autologous fecal microbiota transplantationOther
Individuals will recieve encapsulated freezedried own fecal microbiota to potentially extingish auto-immunity directed against the residual beta cell fraction
| Study group | Role | What they receive |
|---|---|---|
| Encapsulated autologous fecal microbiota transplantation | Experimental | Encapsulated own microbiota to be transplanted from large- to small intestine by oral ingestion Receives: Other: encapsulated autologous fecal microbiota transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at -3, 0, 3 and 6 months.
Secondary outcomes (6)
HbA1c
Changes in plasma biochemistry HbA1c (mmol/mol)
Measured: At -3, 0, 3 and 6 months.
Glycaemic control
Changes in glucose time in range (% of time during last 14 days) as measured with continuous glucose monitoring device.
Measured: At -3, 0, 3 and 6 months.
Fecal microbiota composition
changes in faecal gut microbiota measured with s16 rRNA sequencing to measure the relative abundance of bacterial microbiota (expressed as relative abundance)
Measured: At -3, 0, 3 and 6 months.
Small intestinal microbiota composition
small intestinal microbiota composition measured with s16 rRNA sequencing to measure the relative abundance of bacterial microbiota (in duodenal biopsy), expressed as relative abundance
Measured: Fecal: At -3, 0, 3 and 6 months. Duodenal biopsy: 0 and 3 months
Questionnaire
validated questionnaires for abdominal complaints (on a 0-5 scale)
Measured: At -3, 0, 3 and 6 months.
Dietary intake
to calculate fiber intake (g/day)
Measured: At -3, 0, 3 and 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study startApr 2022 (estimated)
- Primary completionApr 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Encapsulated autologous fecal microbiota transplantation.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nordin Hanssen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nordin Hanssen, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05323162
- Sponsor's protocol ID
- NL79666.018.21
- Acronym
- ENCAPSULATE
- Status last verified
- Apr 2022
- First submitted
- 17 Mar 2022
- Last updated
- 12 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
de Groen P, Fuhri Snethlage CM, Wortelboer K, Tokgoz S, Davids M, Verdoes X, Westerbeke FHM, Meijer RI, Gotthardt M, de Vos WM, Herrema H, Nieuwdorp M, Hanssen NMJ. Autologous fecal microbiota capsules are safe and potentially preserve beta-cell function in individuals with type 1 diabetes. Gut Microbes. 2025 Dec 31;17(1):2563155. doi: 10.1080/19490976.2025.2563155. Epub 2025 Oct 5.
PubMed 41047724
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Encapsulated Faecal Microbiota Transplantation to Preserve Residual Beta Cell Function in Patients With Recently-Diagnosed Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT05323162
- Acronym / sponsor ID
- ENCAPSULATE / NL79666.018.21
- Conditions
- Type 1 Diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Nordin HanssenUniversity, hospital or other
- Study start
- Apr 2022 (estimated)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 12 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. Encapsulated autologous FMT provides a safe and feasible option for prolonged treatment on a daily basis, which might stabilize the beta-cell destruction and extend or even bring back the honeymoon period (wherein individuals with recently diagnosed T1D remain wellregulated with minimal doses of insulin).
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 a mixed meal test (MMT) in recently diagnosed type 1 diabetes mellitus (T1D).
Study design: Open label study Study population: Recently diagnosed (0.5-3.5 years of diagnosis) patients with T1D (n=10, aged 18-65 years, BMI 18-30 kg/m2, male/female).
Intervention: After inclusion in the study and a run-in period of 3 months, stools of the participants will be collected and processed into freeze-dried faecal microbiota capsules, which will be ingested daily for 3 months. Participants will be followed for 9 months after inclusion.
Main study parameters/endpoints: The primary endpoint is long-term preservation of beta cell insulin secretion capacity as assessed by stimulated C-peptide AUC0-120min response upon MMT (at -3, 0, 3 and 6 months). The secondary endpoint pertains to changes in plasma biochemistry (HbA1c levels), glucose time-in-range (Freestyle Libre) and subsequent exogenous insulin dose use at -3, 0, 3 and 6 months. The tertiary endpoint is changes in faecal gut microbiota composition at -3, 0, 3 and 6 months, as well as small intestinal microbiota (duodenal biopsy via gastroscopy at 0 and 3 months).
The fourth endpoint is dietary intake and urinary and plasma metabolites at -3, 0, 3 and 6 months.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: This study is considered an intermediate risk study, mainly due to the duodenal biopsies via gastroscopy at 0 and 3 months. 4 MMTs will be performed, for which 70 ml of blood samples will be drawn each visit. The patient will complete several questionnaires, keep track of a food diary and collect urine and faeces prior to study visits. At the study visits BMI and blood pressure will be measured. As of today no adverse events as result of FMT have been reported in this centre. In addition, the use of autologous faeces comes with a lower risk for transmitting any unknown pathogens compared to an allogenic FMT from a lean healthy donor. Moreover, the encapsulated FMT provides an less invasive, well tolerated alternative to the traditional fresh FMT via nasoduodenal tube. As there currently is no therapy to preserve beta cell function in type 1 diabetes, encapsulated autologous FMT can have a potential benefit for the participants
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Encapsulated autologous fecal microbiota transplantation.
| Arm | Type | Receives |
|---|---|---|
| Encapsulated autologous fecal microbiota transplantation | Experimental | Other: encapsulated autologous fecal microbiota transplantationEncapsulated own microbiota to be transplanted from large- to small intestine by oral ingestion |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
- Remaining residual beta cell function: detectable plasma C-peptide or urinary Cpeptide at inclusion of the study
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| encapsulated autologous fecal microbiota transplantationIndividuals will recieve encapsulated freezedried own fecal microbiota to potentially extingish auto-immunity directed against the residual beta cell fraction | Other | Encapsulated autologous fecal microbiota transplantation |
Primary outcome
Preservation of residual beta cell insulin secretion capacity
Time frame: at -3, 0, 3 and 6 months.
assessed by maximal C-peptide release (residual beta cell function) upon an MMT, AUC0-120 (mmol/ll x min) will be calculated.
6 secondary outcomes
HbA1c
Time frame: At -3, 0, 3 and 6 months.
Glycaemic control
Time frame: At -3, 0, 3 and 6 months.
Fecal microbiota composition
Time frame: At -3, 0, 3 and 6 months.
Small intestinal microbiota composition
Time frame: Fecal: At -3, 0, 3 and 6 months. Duodenal biopsy: 0 and 3 months
Questionnaire
Time frame: At -3, 0, 3 and 6 months.
Dietary intake
Time frame: At -3, 0, 3 and 6 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2022.
- Derived from this study: PubMed 41047724de Groen P, Fuhri Snethlage CM, Wortelboer K, Tokgoz S, Davids M, Verdoes X, Westerbeke FHM, Meijer RI, Gotthardt M, de Vos WM, Herrema H, Nieuwdorp M, Hanssen NMJ. Autologous fecal microbiota capsules are safe and potentially preserve beta-cell function in individuals with type 1 diabetes. Gut Microbes. 2025 Dec 31;17(1):2563155. doi: 10.1080/19490976.2025.2563155. Epub 2025 Oct 5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing encapsulated autologous fecal microbiota transplantation in people with Type 1 Diabetes, run by Nordin Hanssen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fuhri Snethlage, MD (020 566 9111, c.m.fuhrisnethlage@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preservation of residual beta cell insulin secretion capacity (time frame: at -3, 0, 3 and 6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05323162, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2022.