Faecal Microbiota Transplantation (FMT)FadigasNCT04749030

Faecal Microbiota Transplantation for Patients With Diabetes Mellitus Type 1 and Severe Gastrointestinal Neuropathy

A study testing Faecal microbiota transplantation (FMT) capsules in people with Faecal Microbiota Transplantation (FMT) and Diabetes Mellitus, Type 1, run by University of Aarhus at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

A randomised, double-blinded and placebo-controlled intervention study. The study aim to evaluate the feasibility, safety and pilot-efficacy of faecal microbiota transplantation as a treatment of severe gastrointestinal neuropathy in patients with diabetes mellitus type 1. Read more about this study

Who is it for?: Ages 18 to 99 years
Conditions the study is for: Faecal Microbiota Transplantation (FMT), Diabetes Mellitus, Type 1, Gastrointestinal Neuropathy
What is being tested?: Faecal microbiota transplantation (FMT) capsules
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 20 participants
Where: 1 siteDenmark
Study dates: 15 Jun 2021to 1 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 99 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Adult (≥ 18 years old), male or female patients with DM1 for at least 5 years and average of or above 40 points in the questionnaire: Gastrointestinal syndrome rating scale - irritable bowel syndrome version (GSRS-IBS).

Who cannot join

Inability to understand Danish or the trial procedures
Known or anticipated pregnancy
Known severe renal insufficiency
Antibiotic use in the prior 4 weeks
Treatment with morphine
Ongoing infection with Clostridioides difficile or pathogenic intestinal bacteria or parasites

Show all 13Show fewer

Known gastrointestinal disease or GI infection
Patients diagnosed with intestinal stricture
Patients with other known disorder that can cause gastroparesis
Patients with planned MR scan within 4 weeks
Patients with pacemaker/ICD
Previous abdominal surgery
Changes in medicine that affects the GI tract in the prior 4 weeks

Trial locations and contacts

1 site in 1 country.

Denmark1 site

Aarhus University Hospital
Aarhus, 8200

Other trials in Denmark

About this study

Official title: Faecal Microbiota Transplantation for Patients With Diabetes Mellitus Type 1 and Severe Gastrointestinal Neuropathy: a Randomised, Double-blinded Safety and Pilot-efficacy Study

Read the detailed description

Diabetes type 1 may cause damage to nerve cells in the gut causing neuropathy that leads to changes in gastric and intestinal motility. This change predisposes to an abnormal amounts and composition of bacteria in the gut, probably leading to uncontrollable diarrhea and severely impaired quality of life. Transferal of intestinal microbiota from a healthy donor to a patient is called faecal microbiota transplantation (FMT). FMT may potentially change the bacteria in the gut and reduce gastrointestinal symptoms. However, FMT may also have potential side effects, especially in persons with autonomic neuropathy and delayed transit through the gut.

Conditions: Faecal Microbiota Transplantation (FMT), Diabetes Mellitus, Type 1, Gastrointestinal Neuropathy
Being tested: Faecal microbiota transplantation (FMT) capsules, Placebo capsules
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.

Faecal microbiota transplantation (FMT) capsulesOther
The faeces is minimally processed through a series of centrifugation steps and dispensed into double-coated, acid resistant enterocapsules. A single treatment includes approximately 22 capsules (~50 grams of original donor faeces).
Placebo capsulesOther
The placebo capsules are produced from a suspension of 50% glycerol, 40% sterile saline and 10% food coloring in enterocapusles

Study groups in NCT04749030
Study group	Role	What they receive
Faecal microbiota transplantation (FMT)	Other	Donor faeces is obtained from thoroughly screened healthy blood donors and processed in compliance with the European Tissue and Cells Directive. Receives: Other: Faecal microbiota transplantation (FMT) capsules
Placebo	Placebo comparator	Placebo capsules will be identical in terms of visual appearance, weight, and vials and number Receives: Other: Placebo capsules

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of adverse events of severity grade 2 or more assessed by CTCAE v5.0 during the first week after first intervention (FMT or placebo).
Patient-reported measures from the schedule of side effects and telephone call 1 week after each intervention.
Measured: One week after the first intervention

Secondary outcomes (17)

Patient-reported outcomes obtained from the bowel habit diary.
Stool consistency measured by the Bristol scale from 1(severe constipation) to 7 (severe diarrhea)
Measured: Each patient fills out the diary every day for one week at baseline, for one week starting at each day of the two interventions and for one week at the long term follow-up at week 26
Patient-reported outcomes obtained from the bowel habit diary.
Median number of bowel openings per 24 hours.
Measured: Each patient fills out the diary every day for one week at baseline, for one week starting at each day of the two interventions and for one week at the long term follow-up at week 26
Patient-reported outcomes obtained from the bowel habit diary.
Number of nightly bowel openings (from bedtime until morning).
Measured: Each patient fills out the diary every day for one week at baseline, for one week starting at each day of the two interventions and for one week at the long term follow-up at week 26
Patient-reported outcomes obtained from the bowel habit diary.
Number of episodes with involuntary defaecation.
Measured: Each patient fills out the diary every day for one week at baseline, for one week starting at each day of the two interventions and for one week at the long term follow-up at week 26
Patient-reported outcomes obtained from the bowel habit diary.
Glycemic control measured by patient reported use of insulin (IE).
Measured: Each patient fills out the diary every day for one week at baseline, for one week starting at each day of the two interventions and for one week at the long term follow-up at week 26
Patient-reported measures from the schedule of side effects and telephone call 1 week after each intervention.
Mild adverse events (grade 1) following FMT or placebo assessed by CTCAE v5.0.
Measured: One week after each intervention
Patient-reported outcomes from questionnaires.
Change in Gastrointestinal syndrome rating scale - irritable bowel version questionnaire (GSRS-IBS)
Measured: at baseline and 4 weeks after each intervention period and at long term follow-up at week 26
Patient-reported outcomes from questionnaires.
Change in patient assessment of upper gastrointestinal symptom severity index (PAGI-SYM)
Measured: at baseline and 4 weeks after each intervention period and at long term follow-up at week 26
Patient-reported outcomes from questionnaires.
Change in irritable bowel syndrome impact scale (IBS-IS)
Measured: at baseline and 4 weeks after each intervention period and at long term follow-up at week 26
Objective measures from the wireless motility capsule.
Transit time through the small intestine.
Measured: at baseline and 4 weeks after each intervention period
Objective measures from the wireless motility capsule.
Colonic transit time.
Measured: at baseline and 4 weeks after each intervention period
Objective measures from the wireless motility capsule.
pH drop from the small intestine to the colon.
Measured: at baseline and 4 weeks after each intervention period
Objective measures from the low-dose CT scan.
Volume of the a) small intestine and b) the colon. Volume of gas in a) the small intestine and b) the colon.
Measured: at baseline and 4 weeks after the first intervention
Objective measures from the breath test.
Rise in hydrogen PPM measured in breath test for small intestinal bacterial overgrowth.
Measured: at baseline and 4 weeks after the first intervention
Microbiota analysis on faecal samples.
Alpha-diversity of faecal microbiota, 16S. Dysbiosis index.
Measured: at baseline and 4 weeks after each intervention period
Microbiota analysis on faecal samples.
Dysbiosis index.
Measured: at baseline and 4 weeks after each intervention period
Blood samples.
Glycemic control measured by HbA1C levels.
Measured: at baseline and 4 weeks after each intervention period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jun 20211 Oct 2023

First posted10 Feb 2021
Study start15 Jun 2021
Primary completion1 Oct 2023
Study completion1 Oct 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Faecal Microbiota Transplantation (FMT)Studies of the same condition, open and under way.
More trials run by University of AarhusThe 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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Model description: The study is a 8-week, randomised, double-blinded, placebo-controlled pilot trial of oral FMT versus placebo in patients with DM1 and severe GI neuropathy. The intervention period consists of a first 4 weeks where patients receive either FMT or placebo and a second 4 weeks where all patients receive FMT. The patients will undergo the investigations before and after each 4-week period.
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04749030
Sponsor's protocol ID: Fadigas
Acronym: Fadigas
Status last verified: May 2022
First submitted: 1 Feb 2021
Last updated: 13 Dec 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Jorgensen SMD, Hansen MM, Erikstrup C, Dahlerup JF, Hvas CL. Faecal microbiota transplantation: establishment of a clinical application framework. Eur J Gastroenterol Hepatol. 2017 Nov;29(11):e36-e45. doi: 10.1097/MEG.0000000000000958.
PubMed 28863010
Hoyer KL, Kornum DS, Baunwall SMD, Klinge MW, Drewes AM, Yderstraede KB, Mikkelsen S, Erikstrup C, Krogh K, Hvas CL. Repeated faecal microbiota transplantation for individuals with type 1 diabetes and gastroenteropathy. Diabetologia. 2025 Dec;68(12):2795-2806. doi: 10.1007/s00125-025-06544-x. Epub 2025 Sep 18.
PubMed 40965701
Hoyer KL, Dahl Baunwall SM, Kornum DS, Klinge MW, Drewes AM, Yderstraede KB, Thingholm LB, Mortensen MS, Mikkelsen S, Erikstrup C, Hvas CL, Krogh K. Faecal microbiota transplantation for patients with diabetes type 1 and severe gastrointestinal neuropathy (FADIGAS): a randomised, double-blinded, placebo-controlled trial. EClinicalMedicine. 2024 Dec 16;79:103000. doi: 10.1016/j.eclinm.2024.103000. eCollection 2025 Jan.
PubMed 39791110

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 2
Response to Emerging Antimicrobial Resistance With Containment Microbiota Therapy (REACT)
Multi-Drug Resistant Organism Colonization
Recruiting
Fecal Microbiota Transplantation (FMT) as a Prophylaxis of Necrotizing Enterocolitis (NEC) - Clinical Study
Necrotizing Enterocolitis (NEC), Necrotizing Enterocolitis of Newborn
Active, not recruitingPhase 2
Autologous Fecal Microbiota Transplantation (Auto-FMT) for Prophylaxis of Clostridium Difficile Infection in Recipients of Allogeneic Hematopoietic Stem Cell Transplantation
Allogeneic Hematopoietic Stem Cell
RecruitingPhase 1/2
Tributyrin for Progressive Supranuclear Palsy (PSP): Virtual Trial
Parkinson Disease, Multiple System Atrophy
RecruitingPhase 1/2
Safety, Dosage, and Microbiome Engraftment Study of MGT-006 for Ulcerative Colitis (ROOT Study)
Ulcerative Colitis (UC), Ulcerative Colitis, Active Moderate

All Faecal Microbiota Transplantation (FMT) trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Faecal Microbiota Transplantation for Patients With Diabetes Mellitus Type 1 and Severe Gastrointestinal Neuropathy: a Randomised, Double-blinded Safety and Pilot-efficacy Study
ClinicalTrials.gov ID: NCT04749030
Acronym / sponsor ID: Fadigas / Fadigas
Conditions: Faecal Microbiota Transplantation (FMT), Diabetes Mellitus, Type 1, Gastrointestinal Neuropathy
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: University of AarhusUniversity, hospital or other
Study start: 15 Jun 2021 (actual)
Primary completion: 1 Oct 2023 (actual)
Study completion: 1 Oct 2023 (actual)
First posted: 10 Feb 2021 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: The study is a 8-week, randomised, double-blinded, placebo-controlled pilot trial of oral FMT versus placebo in patients with DM1 and severe GI neuropathy. The intervention period consists of a first 4 weeks where patients receive either FMT or placebo and a second 4 weeks where all patients receive FMT. The patients will undergo the investigations before and after each 4-week period.

Arm	Type	Receives
Faecal microbiota transplantation (FMT)	Other	Other: Faecal microbiota transplantation (FMT) capsulesDonor faeces is obtained from thoroughly screened healthy blood donors and processed in compliance with the European Tissue and Cells Directive.
Placebo	Placebo comparator	Other: Placebo capsulesPlacebo capsules will be identical in terms of visual appearance, weight, and vials and number

Who may qualify

Ages: 18 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Adult (≥ 18 years old), male or female patients with DM1 for at least 5 years and average of or above 40 points in the questionnaire: Gastrointestinal syndrome rating scale - irritable bowel syndrome version (GSRS-IBS).

Key exclusion criteria (13 listed)

Inability to understand Danish or the trial procedures
Known or anticipated pregnancy
Known severe renal insufficiency
Antibiotic use in the prior 4 weeks
Treatment with morphine

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
Faecal microbiota transplantation (FMT) capsulesThe faeces is minimally processed through a series of centrifugation steps and dispensed into double-coated, acid resistant enterocapsules. A single treatment includes approximately 22 capsules (~50 grams of original donor faeces).	Other	Faecal microbiota transplantation (FMT)
Placebo capsulesThe placebo capsules are produced from a suspension of 50% glycerol, 40% sterile saline and 10% food coloring in enterocapusles	Other	Placebo

Primary outcome

Number of adverse events of severity grade 2 or more assessed by CTCAE v5.0 during the first week after first intervention (FMT or placebo).
Time frame: One week after the first intervention
Patient-reported measures from the schedule of side effects and telephone call 1 week after each intervention.

17 secondary outcomes

Patient-reported outcomes obtained from the bowel habit diary.
Time frame: Each patient fills out the diary every day for one week at baseline, for one week starting at each day of the two interventions and for one week at the long term follow-up at week 26
Patient-reported outcomes obtained from the bowel habit diary.
Time frame: Each patient fills out the diary every day for one week at baseline, for one week starting at each day of the two interventions and for one week at the long term follow-up at week 26
Patient-reported outcomes obtained from the bowel habit diary.
Time frame: Each patient fills out the diary every day for one week at baseline, for one week starting at each day of the two interventions and for one week at the long term follow-up at week 26
Patient-reported outcomes obtained from the bowel habit diary.
Time frame: Each patient fills out the diary every day for one week at baseline, for one week starting at each day of the two interventions and for one week at the long term follow-up at week 26
Patient-reported outcomes obtained from the bowel habit diary.
Time frame: Each patient fills out the diary every day for one week at baseline, for one week starting at each day of the two interventions and for one week at the long term follow-up at week 26
Patient-reported measures from the schedule of side effects and telephone call 1 week after each intervention.
Time frame: One week after each intervention
Patient-reported outcomes from questionnaires.
Time frame: at baseline and 4 weeks after each intervention period and at long term follow-up at week 26
Patient-reported outcomes from questionnaires.
Time frame: at baseline and 4 weeks after each intervention period and at long term follow-up at week 26
Patient-reported outcomes from questionnaires.
Time frame: at baseline and 4 weeks after each intervention period and at long term follow-up at week 26
Objective measures from the wireless motility capsule.
Time frame: at baseline and 4 weeks after each intervention period
Objective measures from the wireless motility capsule.
Time frame: at baseline and 4 weeks after each intervention period
Objective measures from the wireless motility capsule.
Time frame: at baseline and 4 weeks after each intervention period
Objective measures from the low-dose CT scan.
Time frame: at baseline and 4 weeks after the first intervention
Objective measures from the breath test.
Time frame: at baseline and 4 weeks after the first intervention
Microbiota analysis on faecal samples.
Time frame: at baseline and 4 weeks after each intervention period
Microbiota analysis on faecal samples.
Time frame: at baseline and 4 weeks after each intervention period
Blood samples.
Time frame: at baseline and 4 weeks after each intervention period

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
Background: PubMed 28863010Jorgensen SMD, Hansen MM, Erikstrup C, Dahlerup JF, Hvas CL. Faecal microbiota transplantation: establishment of a clinical application framework. Eur J Gastroenterol Hepatol. 2017 Nov;29(11):e36-e45. doi: 10.1097/MEG.0000000000000958.
Derived from this study: PubMed 40965701Hoyer KL, Kornum DS, Baunwall SMD, Klinge MW, Drewes AM, Yderstraede KB, Mikkelsen S, Erikstrup C, Krogh K, Hvas CL. Repeated faecal microbiota transplantation for individuals with type 1 diabetes and gastroenteropathy. Diabetologia. 2025 Dec;68(12):2795-2806. doi: 10.1007/s00125-025-06544-x. Epub 2025 Sep 18.
Derived from this study: PubMed 39791110Hoyer KL, Dahl Baunwall SM, Kornum DS, Klinge MW, Drewes AM, Yderstraede KB, Thingholm LB, Mortensen MS, Mikkelsen S, Erikstrup C, Hvas CL, Krogh K. Faecal microbiota transplantation for patients with diabetes type 1 and severe gastrointestinal neuropathy (FADIGAS): a randomised, double-blinded, placebo-controlled trial. EClinicalMedicine. 2024 Dec 16;79:103000. doi: 10.1016/j.eclinm.2024.103000. eCollection 2025 Jan.
Individual participant dataSharing planned: No

Related trials for Faecal Microbiota Transplantation (FMT)

Active, not recruitingPhase 2
Response to Emerging Antimicrobial Resistance With Containment Microbiota Therapy (REACT)
Multi-Drug Resistant Organism Colonization
Recruiting
Fecal Microbiota Transplantation (FMT) as a Prophylaxis of Necrotizing Enterocolitis (NEC) - Clinical Study
Necrotizing Enterocolitis (NEC), Necrotizing Enterocolitis of Newborn
Active, not recruitingPhase 2
Autologous Fecal Microbiota Transplantation (Auto-FMT) for Prophylaxis of Clostridium Difficile Infection in Recipients of Allogeneic Hematopoietic Stem Cell Transplantation
Allogeneic Hematopoietic Stem Cell
RecruitingPhase 1/2
Tributyrin for Progressive Supranuclear Palsy (PSP): Virtual Trial
Parkinson Disease, Multiple System Atrophy
RecruitingPhase 1/2
Safety, Dosage, and Microbiome Engraftment Study of MGT-006 for Ulcerative Colitis (ROOT Study)
Ulcerative Colitis (UC), Ulcerative Colitis, Active Moderate

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.

Klaus Krogh, MD, DMSc, PhD, Professor principal investigator

Department of Hepatology and Gastroenterology, Aarhus University Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 1 inclusion and 13 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: finished, as of the sponsor's last update on 13 Dec 2024. 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 Denmark. 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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of adverse events of severity grade 2 or more assessed by CTCAE v5.0 during the first week after first intervention (FMT or placebo). (time frame: One week after the first intervention). 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 NCT04749030, which also lists 3 linked publications.

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 13 Dec 2024.