DiarrheaFaeMiCueNCT06333795
Faecal Microbiota Transplantation Against Chronic Diarrhea in Patients With Systemic Sclerosis
A study testing Faecal Microbiota Transplantation (FMT) in people with Diarrhea and Systemic Sclerosis, run by University of Aarhus at 1 site in Denmark.
Trial summary
This clinical trial aims to assess the safety and effectiveness of faecal Microbiota Transplantation (FMT) in improving chronic diarrhea symptoms among patients with systemic sclerosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diarrhea, Systemic Sclerosis
- What is being tested?
- Faecal Microbiota Transplantation (FMT)
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Apr 2024to 23 Feb 2026
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants > 18 years
- Fulfilling and previously diagnosed with SSc according to the 2013 American College of Rheumatology/European League against rheumatisms SSs classification criteria[23] by rheumatologist or dermatologist.
- Chronic diarrea is defined as loose or watery stools, three or more times a day, a minimum of 50% of the days within the last four weeks.
Who cannot join
- Inability to understand Danish spoken or written and/or Trial procedures.
- Known or anticipated pregnancy (excluded by male sex, postmenopausal women, or otherwise negative U-HCG)
- Previous treatment with FMT
- Treatment with antibiotics within the past 6 weeks
- Changes in morphine treatment within the past 4 weeks
- Ongoing infection with Clostridioides difficile (negative PCR test)
Show all 17Show fewer
- Known serious gastrointestinal disease or GI infection (diagnosed with e.g. inflammatory bowel disease and/or gastrointestinal cancer)
- Dysregulated thyroid disease (TSH) blood sample from previous consultations maximum 6 months old from
- Known intestinal stricture
- Planned MR scan within the study period
- Pacemaker/ICD
- Previous abdominal surgery (minor surgical procedures ex. appendectomy is allowed)
- Changes in medicine that affect the GI tract within the past four weeks.
- Known Severe end-organ disease
- Lung disease with forced vital capacity(FVC)<50% and/or diffusing lung capacity for carbon monoxide (DLCO) <40%
- Severe heart failure with ejection fraction <30%
- End-stage kidney disease with glomeration rate<30ml/min
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Faecal Microbiota Transplantation Against Chronic Diarrhea in Patients With Systemic Sclerosis - a Randomized, Double-blinded, Safety and Pilot-efficacy Study
This clinical trial aims to assess the safety and effectiveness of faecal Microbiota Transplantation (FMT) in improving chronic diarrhea symptoms among patients with systemic sclerosis.
Read the detailed description
The present study aims to assess the feasibility, pilot efficacy, and safety of FMT for patients with Systemic Sclerosis.
Participants will undergo two interventions in this present study.
In the first intervention, participants are randomized 1:1 for either active FMT or Placebo. This first intervention consists of two doses of FMT with a 3-7 day gap.
In the second intervention, all participants receive 1 dose of active FMT treatment.
This study design allows researchers to evaluate the safety of FMT in this patient group, and compare the effects of FMT in the FMT-treated group vs the placebo group, to see if FMT promotes remission of Chronic diarrhea. Furthermore, researchers will be able to gain insights into whether 2 initial doses are superior to one.
- Conditions
- Diarrhea, Systemic Sclerosis
- Being tested
- Faecal Microbiota Transplantation (FMT), Placebo
- Keywords
- Faecal Microbiota Transplantation (FMT), Diarrhea, Systemic Sclerosis, Chronic Diarrhea
- Medical subject headings
- Diarrhea, Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Faecal Microbiota Transplantation (FMT)Procedure or surgery
Treatment is given as capsules.
PlaceboProcedure or surgery
Treatment is given as capsules.
| Study group | Role | What they receive |
|---|---|---|
| Active treatment | Experimental | Active capsule FMT-treatment Receives: Procedure: Faecal Microbiota Transplantation (FMT) |
| Placebo | Placebo comparator | Placebo capsules are given. Receives: Procedure: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events (AE) severity grade 2 or more assessed by CTCAE v5.0. during the first week after intervention (FMT or placebo).
Patient-reported measures from the schedule of side effects and telephone call 1 week after each intervention.
Measured: The first week after treatment.
Secondary outcomes (19)
Patient-reported treatment outcome on symptoms
Based on self-reported data from the bowel habit diary.
Measured: The first week after treatment.
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 (Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0) CTCAE v5.0.
The CTCAE grades adverse events (AEs) based on severity:
Grade 1: Mild, asymptomatic, or mild symptoms; no intervention needed. Grade 2: Moderate; requires minimal intervention; affects age-appropriate activities.
Grade 3: Severe or medically significant, not immediately life-threatening; may require hospitalization.
Grade 4: Life-threatening; urgent intervention needed. Grade 5: AE-related death. Note: Some AEs may not have all five grades available.
Measured: One week after each treatment
Patient-reported outcomes from questionnaires.
Change in Gastrointestinal syndrome rating scale - irritable bowel version questionnaire (GSRS-IBS)
Measured: At Baseline and 4 weeks after Intervention 1 & 2
Patient-reported outcomes from questionnaires.
Change in Wexner incontinence score.
Measured: At Baseline and 4 weeks after Intervention 1 & 2
Patient-reported outcomes from questionnaires.
Change in UCLA Scleroderma Clinical Trial Consortium Gastrointestinal Tract (UCLA SCTC GIT 2.0)
Measured: At Baseline and 4 weeks after Intervention 1 & 2
Patient-reported overall symptom burden
The patients self-reported the severity of symptoms and their impact on daily life each week on a scale from 1-5. 1 being little to no burden, 5 being most severe.
Measured: Each week for a total of 26 weeks.
Objective measures from the wireless motility capsule.
Transit time through the small intestine.
Measured: At baseline
Objective measures from the wireless motility capsule.
Colonic transit times
Measured: At baseline
Objective measures from the wireless motility capsule.
Total gastrointestinal transittimes
Measured: At baseline
Objective measures from the wireless motility capsule.
Ph drop from the small intestine to the colon
Measured: At baseline
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.
Changes in the gas volume in the small intestine and colon.
Measured: At baseline and 4 weeks after first intervention
Breath Test
Changes in the rise of hydrogen and methane measured in breath test
Measured: At baseline and 4 weeks after first intervention
Faecal microbiota composition
Changes in faecal microbiome composition. Alfa and beta diversity determined by sequencing of the intestinal microbiome.
Measured: At baseline and between each treatment, up to 4 weeks after last intervention
Faecal-calprotectin
Percentual change in faecal-calprotectin from before intervention to 4 weeks after each intervention.
Measured: At Baseline and 4 weeks after Intervention 1 & 2
Blood plasma proteomics
Changes in blood immunological parameters (including proteins) from baseline and between each treatment, at 4 weeks after intervention.
Measured: At baseline and between each treatment, up to four weeks after last intervention.
Blood plasma Fibrosis markers
Changes in blood immunological parameters (including markers of fibrosis) from baseline and between each treatment, at 4 weeks after intervention.
Measured: At baseline and between each treatment, up to four weeks after last intervention.
Blood parameters
Changes in blood immunological parameters (including circulating cytokines) from baseline and between each treatment, at 4 weeks after intervention.
Measured: At baseline and between each treatment, up to four weeks after last intervention.
Health-related Quality of life
Changes in Health-related Quality of life assessed with (EQ-5D-5L). Each of the five dimensions comprising the EQ-5D descriptive system is divided into five levels of perceived problems: LEVEL 1: indicating no problem LEVEL 2: indicating slight problems LEVEL 3: indicating moderate problems LEVEL 4: indicating severe problems LEVEL 5: indicating unable to/Extreme problems
An EQ-VAS from 0-100 is added, 100 being the best possible health.
Measured: At baseline and 4 weeks after Intervention 1 & 2
Patient perception of FMT treatment satisfaction
Patient perception of FMT treatment satisfaction was assessed by 7-point Likert scale for patients. 1: no benefits from treatment to 7 being very satisfied with treatment.
Measured: At 4 weeks after interventions 1 & 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study start1 Apr 2024
- Primary completion21 Jan 2026
- Study completion23 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiarrheaStudies 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
- Parallel groups
- Model description
- Participants will undergo 2 interventions. For the first intervention participants are randomised 1:1 for either Active FMT or placebo For the second intervention, all participants receive active treatment.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Klaus Krogh, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06333795
- Sponsor's protocol ID
- 1-10-72-131-23
- Acronym
- FaeMiCue
- Status last verified
- Mar 2026
- First submitted
- 5 Mar 2024
- Last updated
- 4 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Faecal Microbiota Transplantation Against Chronic Diarrhea in Patients With Systemic Sclerosis - a Randomized, Double-blinded, Safety and Pilot-efficacy Study
- ClinicalTrials.gov ID
- NCT06333795
- Acronym / sponsor ID
- FaeMiCue / 1-10-72-131-23
- Conditions
- Diarrhea, Systemic Sclerosis
- Keywords
- Faecal Microbiota Transplantation (FMT), Diarrhea, Systemic Sclerosis, Chronic Diarrhea
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 21 Jan 2026 (actual)
- Study completion
- 23 Feb 2026 (estimated)
- First posted
- 27 Mar 2024 (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.
This clinical trial aims to assess the safety and effectiveness of faecal Microbiota Transplantation (FMT) in improving chronic diarrhea symptoms among patients with systemic sclerosis.
Detailed description
The present study aims to assess the feasibility, pilot efficacy, and safety of FMT for patients with Systemic Sclerosis.
Participants will undergo two interventions in this present study.
In the first intervention, participants are randomized 1:1 for either active FMT or Placebo. This first intervention consists of two doses of FMT with a 3-7 day gap.
In the second intervention, all participants receive 1 dose of active FMT treatment.
This study design allows researchers to evaluate the safety of FMT in this patient group, and compare the effects of FMT in the FMT-treated group vs the placebo group, to see if FMT promotes remission of Chronic diarrhea. Furthermore, researchers will be able to gain insights into whether 2 initial doses are superior to one.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will undergo 2 interventions. For the first intervention participants are randomised 1:1 for either Active FMT or placebo For the second intervention, all participants receive active treatment.
| Arm | Type | Receives |
|---|---|---|
| Active treatment | Experimental | Procedure: Faecal Microbiota Transplantation (FMT)Active capsule FMT-treatment |
| Placebo | Placebo comparator | Procedure: PlaceboPlacebo capsules are given. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants > 18 years
- Fulfilling and previously diagnosed with SSc according to the 2013 American College of Rheumatology/European League against rheumatisms SSs classification criteria[23] by rheumatologist or dermatologist.
- Chronic diarrea is defined as loose or watery stools, three or more times a day, a minimum of 50% of the days within the last four weeks.
Key exclusion criteria (17 listed)
- Inability to understand Danish spoken or written and/or Trial procedures.
- Known or anticipated pregnancy (excluded by male sex, postmenopausal women, or otherwise negative U-HCG)
- Previous treatment with FMT
- Treatment with antibiotics within the past 6 weeks
- Changes in morphine treatment within the past 4 weeks
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)Treatment is given as capsules. | Procedure or surgery | Active treatment |
| PlaceboTreatment is given as capsules. | Procedure or surgery | Placebo |
Primary outcome
Number of adverse events (AE) severity grade 2 or more assessed by CTCAE v5.0. during the first week after intervention (FMT or placebo).
Time frame: The first week after treatment.
Patient-reported measures from the schedule of side effects and telephone call 1 week after each intervention.
19 secondary outcomes
Patient-reported treatment outcome on symptoms
Time frame: The first week after treatment.
Patient-reported measures from the schedule of side effects and telephone call 1 week after each intervention.
Time frame: One week after each treatment
Patient-reported outcomes from questionnaires.
Time frame: At Baseline and 4 weeks after Intervention 1 & 2
Patient-reported outcomes from questionnaires.
Time frame: At Baseline and 4 weeks after Intervention 1 & 2
Patient-reported outcomes from questionnaires.
Time frame: At Baseline and 4 weeks after Intervention 1 & 2
Patient-reported overall symptom burden
Time frame: Each week for a total of 26 weeks.
Objective measures from the wireless motility capsule.
Time frame: At baseline
Objective measures from the wireless motility capsule.
Time frame: At baseline
Objective measures from the wireless motility capsule.
Time frame: At baseline
Objective measures from the wireless motility capsule.
Time frame: At baseline
Objective measures from the low-dose CT scan.
Time frame: At baseline and 4 weeks after first intervention
Breath Test
Time frame: At baseline and 4 weeks after first intervention
Faecal microbiota composition
Time frame: At baseline and between each treatment, up to 4 weeks after last intervention
Faecal-calprotectin
Time frame: At Baseline and 4 weeks after Intervention 1 & 2
Blood plasma proteomics
Time frame: At baseline and between each treatment, up to four weeks after last intervention.
Blood plasma Fibrosis markers
Time frame: At baseline and between each treatment, up to four weeks after last intervention.
Blood parameters
Time frame: At baseline and between each treatment, up to four weeks after last intervention.
Health-related Quality of life
Time frame: At baseline and 4 weeks after Intervention 1 & 2
Patient perception of FMT treatment satisfaction
Time frame: At 4 weeks after interventions 1 & 2
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 4 Mar 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Faecal Microbiota Transplantation (FMT) in people with Diarrhea and Systemic Sclerosis, run by University of Aarhus at 1 site in Denmark.
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 3 inclusion and 17 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: under way, not looking for participants, as of the sponsor's last update on 4 Mar 2026. 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?
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?
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 (AE) severity grade 2 or more assessed by CTCAE v5.0. during the first week after intervention (FMT or placebo). (time frame: The first week after 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 4 Mar 2026.