Type 1 Diabetes MellitisPhase 2FACT-T1DNCT07083882
Faecal Autologous Capsule Transplantation for Type 1 Diabetes Mellitus
A Phase 2 study testing freezedried autologous encapsulated fecal microbiota transplantation in people with Type 1 Diabetes Mellitis and Type 1 Diabetes (T1D), run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Type 1 Diabetes Mellitis, Type 1 Diabetes (T1D), Fecal Microbiota Therapy (FMT)
- What is being tested?
- freezedried autologous encapsulated fecal microbiota transplantation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2025to Sep 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female recently diagnosed (<100 days) with type 1 diabetes mellitus.
- Age:18-45 years
- BMI: 18-30 kg/m2
- Remaining residual beta cell function: detectable plasma C-peptide or urinary C-peptide at inclusion of the study.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Max Nieuwdorp, MD PhD contact
Netherlands1 site, 1 recruiting
- Recruiting
Diabeter Centrum Amsterdam
Amsterdam
Nordin MJ Hanssen, MD PhD, 088-280 91 00
About this study
SUMMARY
Rationale:
Read more
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.
Read the detailed description
OBJECTIVES This study is designed to confirm whether a microbial intervention based on capsules containing autologous (own) lyophilized faecal microbiota, LFMCs, taken daily for 6 months has beneficial effects on residual beta cell function (C-peptide secretion uponMMT) in recently diagnosed type 1 diabetes mellitus compared to placebo. A parallel objective is to assess the impact on glycaemic control.
To investigate the effect of daily oral intake of autologous LFMCs on:
I Preservation of residual beta cell insulin secretion capacity: assessed by maximal C-peptiderelease(residual beta cell function)upon an MMT, AUC0-120min at 0,6 and 12 months. As an additional marker of residual beta cell function, at home post-meal urinary C-peptide levels will be used.
II Glycaemic control: changes in plasma biochemistry (glucose, HbA1c), glucose time in range (FreestyleLibre), urine (microalbuminuria) and subsequent exogenous insulin dose use at 0,6 and 12months.
III Questionnaires and dietary intake: validated questionnaires for abdominal complaints, diabetic complications and hypoglycaemia frequency at 0,6 and 12 months. Dietary intake will be registered via online dietary lists at 0,6 and 12months.
STUDY DESIGN This is a placebo controlled, double blind, single-centre study. After the randomisation, in a 1:2 (placebo:LFMC) ratio using a validated variable block randomization model in Castor, stratified for sex with block sizes 4,6 and 8, participants will ingest the autologous LFMCs or placebo daily for 6months, which will be followed by a follow-up period of 6months. In total, participants will be followed for12months after inclusion.
Study visits Subjects will in principle visit 3 times in total for this study, with 1 prior screening visit that essentially encompasses participation in the MARVEL cohort (NL85375.018.23, measuring residual beta cell function and questionnaires) and one visit to pick up the second batch of capsules. Each visit will take 180 minutes (maximum of 12 hours over 12 months).
Screening Blood will be drawn for basic biochemistry and patients will hand in the food diaries, questionnaires. In addition, height, weight, blood pressure will be measured and BMI will be calculated. As the faeces is needed to produce the autologous LFMCs, participants are instructed to collect at least 300 grams of fresh faeces. If the fresh faeces is insufficient (<300g), participants are asked to collect more fresh faeces and bring thisto the AMC at a later date (but before the baseline visit).
Optional: additional fecal collections. It may be the case that individuals produce insufficient feces at once, in that case participants are asked to bring in addition samples until 300g is reached.
Visit1: baseline visit (0 months) At baseline a MMT will be performed, blood will be drawn for basic biochemistry and patients will hand in the food diaries, questionnaires and their fecal and 2h post-meal urine sample. Thereafter, the participant will start with the LFMCs for 6months. The first capsule is ingested with the investigator present to ensure the participant tolerates the capsules well and has an appropriate intake technique.
Visit 2 (3months): by phone to evaluate compliance and potential side-effects.
Visit3: follow-up visit (6months) During this visit the MMT will be repeated, blood will be drawn for basic biochemistry and patients will hand in the food diaries and questionnaires and their 2h post-meal urine sample. In addition, height, weight, blood pressure are measured again. Participants stop with the LFMCs and return any remaining capsules to the investigator.
Visit4: follow-up visit (12months) During this last visit, the MMT will berepeated, blood will be drawn for basic biochemistry and patients will hand in the food diaries, questionnaires and their 2h post-meal urine sample. In addition, height, weight, blood pressure are measured again.
- Being tested
- freezedried autologous encapsulated fecal microbiota transplantation, placebo matching capsule without microbial content
- Keywords
- microbiome, type 1 diabetes, microbiota transplant
- 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.
freezedried autologous encapsulated fecal microbiota transplantationBiological
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.
placebo matching capsule without microbial contentOther
this is the matching placebo capsule that looks from the outside identical to the actual treatment but does not contain the fecal microbiota.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Other: placebo matching capsule without microbial content |
| Encapsulated autologous fecal microbiota transplantation | Experimental | Not described Receives: Biological: freezedried autologous encapsulated 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
measured by plasma C-peptide in mixed meal and 2hour post meal urine sample
Measured: At baseline, at 6 months upon completion of treatment and at 12 months after intiation of treatment
Secondary outcomes (4)
Hba1c
expressed as mmol-mol
Measured: At baseline, at 6 months upon completion of treatment and at 12 months after intiation of treatment
Continuous glucose monitoring
Time in range expressed as % and time below range expressed as %
Measured: At baseline, at 6 months upon completion of treatment and at 12 months after intiation of treatment
albuminuria
expressed as ratio urinary albumin an kreatinin, as mg-mol
Measured: At baseline, at 6 months upon completion of treatment and at 12 months after intiation of treatment
exogenous insulin dose
expressed as units used per 24 hours
Measured: At baseline, at 6 months upon completion of treatment and at 12 months after intiation of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study startSep 2025 (estimated)
- Primary completionSep 2029 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitisStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Diabeter Centrum Amsterdam
- Responsible party
- Principal investigator, Nordin Hanssen, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07083882
- Sponsor's protocol ID
- METC2025.0067
- Acronym
- FACT-T1D
- Status last verified
- Jul 2025
- First submitted
- 11 Jul 2025
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Faecal Autologous Capsule Transplantation for Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT07083882
- Acronym / sponsor ID
- FACT-T1D / METC2025.0067
- Keywords
- microbiome, type 1 diabetes, microbiota transplant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- Diabeter Centrum Amsterdam
- Study start
- Sep 2025 (estimated)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 24 Jul 2025 (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.
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.
Detailed description
OBJECTIVES This study is designed to confirm whether a microbial intervention based on capsules containing autologous (own) lyophilized faecal microbiota, LFMCs, taken daily for 6 months has beneficial effects on residual beta cell function (C-peptide secretion uponMMT) in recently diagnosed type 1 diabetes mellitus compared to placebo. A parallel objective is to assess the impact on glycaemic control.
To investigate the effect of daily oral intake of autologous LFMCs on:
I Preservation of residual beta cell insulin secretion capacity: assessed by maximal C-peptiderelease(residual beta cell function)upon an MMT, AUC0-120min at 0,6 and 12 months. As an additional marker of residual beta cell function, at home post-meal urinary C-peptide levels will be used.
II Glycaemic control: changes in plasma biochemistry (glucose, HbA1c), glucose time in range (FreestyleLibre), urine (microalbuminuria) and subsequent exogenous insulin dose use at 0,6 and 12months.
III Questionnaires and dietary intake: validated questionnaires for abdominal complaints, diabetic complications and hypoglycaemia frequency at 0,6 and 12 months. Dietary intake will be registered via online dietary lists at 0,6 and 12months.
STUDY DESIGN This is a placebo controlled, double blind, single-centre study. After the randomisation, in a 1:2 (placebo:LFMC) ratio using a validated variable block randomization model in Castor, stratified for sex with block sizes 4,6 and 8, participants will ingest the autologous LFMCs or placebo daily for 6months, which will be followed by a follow-up period of 6months. In total, participants will be followed for12months after inclusion.
Study visits Subjects will in principle visit 3 times in total for this study, with 1 prior screening visit that essentially encompasses participation in the MARVEL cohort (NL85375.018.23, measuring residual beta cell function and questionnaires) and one visit to pick up the second batch of capsules. Each visit will take 180 minutes (maximum of 12 hours over 12 months).
Screening Blood will be drawn for basic biochemistry and patients will hand in the food diaries, questionnaires. In addition, height, weight, blood pressure will be measured and BMI will be calculated. As the faeces is needed to produce the autologous LFMCs, participants are instructed to collect at least 300 grams of fresh faeces. If the fresh faeces is insufficient (<300g), participants are asked to collect more fresh faeces and bring thisto the AMC at a later date (but before the baseline visit).
Optional: additional fecal collections. It may be the case that individuals produce insufficient feces at once, in that case participants are asked to bring in addition samples until 300g is reached.
Visit1: baseline visit (0 months) At baseline a MMT will be performed, blood will be drawn for basic biochemistry and patients will hand in the food diaries, questionnaires and their fecal and 2h post-meal urine sample. Thereafter, the participant will start with the LFMCs for 6months. The first capsule is ingested with the investigator present to ensure the participant tolerates the capsules well and has an appropriate intake technique.
Visit 2 (3months): by phone to evaluate compliance and potential side-effects.
Visit3: follow-up visit (6months) During this visit the MMT will be repeated, blood will be drawn for basic biochemistry and patients will hand in the food diaries and questionnaires and their 2h post-meal urine sample. In addition, height, weight, blood pressure are measured again. Participants stop with the LFMCs and return any remaining capsules to the investigator.
Visit4: follow-up visit (12months) During this last visit, the MMT will berepeated, blood will be drawn for basic biochemistry and patients will hand in the food diaries, questionnaires and their 2h post-meal urine sample. In addition, height, weight, blood pressure are measured again.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: placebo matching capsule without microbial content |
| Encapsulated autologous fecal microbiota transplantation | Experimental | Biological: freezedried autologous encapsulated fecal microbiota transplantation |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male or female recently diagnosed (<100 days) with type 1 diabetes mellitus.
- Age:18-45 years
- BMI: 18-30 kg/m2
- Remaining residual beta cell function: detectable plasma C-peptide or urinary C-peptide at inclusion of the study.
Key exclusion criteria (7 listed)
- 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.
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 |
|---|---|---|
| freezedried autologous encapsulated fecal microbiota transplantationThe 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. | Biological | Encapsulated autologous fecal microbiota transplantation |
| placebo matching capsule without microbial contentthis is the matching placebo capsule that looks from the outside identical to the actual treatment but does not contain the fecal microbiota. | Other | Placebo |
Primary outcome
Preservation of residual beta cell insulin secretion capacity
Time frame: At baseline, at 6 months upon completion of treatment and at 12 months after intiation of treatment
measured by plasma C-peptide in mixed meal and 2hour post meal urine sample
4 secondary outcomes
Hba1c
Time frame: At baseline, at 6 months upon completion of treatment and at 12 months after intiation of treatment
Continuous glucose monitoring
Time frame: At baseline, at 6 months upon completion of treatment and at 12 months after intiation of treatment
albuminuria
Time frame: At baseline, at 6 months upon completion of treatment and at 12 months after intiation of treatment
exogenous insulin dose
Time frame: At baseline, at 6 months upon completion of treatment and at 12 months after intiation of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
- 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.
Max Nieuwdorp, MD PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing freezedried autologous encapsulated fecal microbiota transplantation in people with Type 1 Diabetes Mellitis and Type 1 Diabetes (T1D), run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) 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 4 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 24 Jul 2025. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nordin MJ Hanssen, MD PhD (020 566 9111, n.m.j.hanssen@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 baseline, at 6 months upon completion of treatment and at 12 months after intiation of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jul 2025.