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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active treatment | Experimental | Active capsule FMT-treatment |
|
| Placebo | Placebo Comparator | Placebo capsules are given. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Faecal Microbiota Transplantation (FMT) | Procedure | Treatment is given as capsules. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | The first week after treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-reported treatment outcome on symptoms | Based on self-reported data from the bowel habit diary. | The first week after treatment. |
| Patient-reported measures from the schedule of side effects and telephone call 1 week after each intervention. |
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Inclusion Criteria:
Exclusion Criteria:
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)
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital | Aarhus | Denmark |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 2, 2026 | Mar 2, 2026 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003967 | Diarrhea |
| D012595 | Scleroderma, Systemic |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003240 | Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000069467 | Fecal Microbiota Transplantation |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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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.
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The study is blinded throughout the active study period, both the patient and investigator are blinded.
| Placebo |
| Procedure |
Treatment is given as capsules. |
|
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.
| One week after each treatment |
| Patient-reported outcomes from questionnaires. | Change in Gastrointestinal syndrome rating scale - irritable bowel version questionnaire (GSRS-IBS) | At Baseline and 4 weeks after Intervention 1 & 2 |
| Patient-reported outcomes from questionnaires. | Change in Wexner incontinence score. | 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) | 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. | Each week for a total of 26 weeks. |
| Objective measures from the wireless motility capsule. | Transit time through the small intestine. | At baseline |
| Objective measures from the wireless motility capsule. | Colonic transit times | At baseline |
| Objective measures from the wireless motility capsule. | Total gastrointestinal transittimes | At baseline |
| Objective measures from the wireless motility capsule. | Ph drop from the small intestine to the colon | 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. | At baseline and 4 weeks after first intervention |
| Breath Test | Changes in the rise of hydrogen and methane measured in breath test | 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. | 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. | 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. | 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. | 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. | 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. | 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. | At 4 weeks after interventions 1 & 2 |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |