Clinical trial NCT06333795: Faecal Microbiota Transplantation Against Chronic Diarrhea in Patients With Systemic Sclerosis
Official title: Faecal Microbiota Transplantation Against Chronic Diarrhea in Patients With Systemic Sclerosis - a Randomized, Double-blinded, Safety and Pilot-efficacy Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Diarrhea
Systemic Sclerosis
Keywords: Faecal Microbiota Transplantation (FMT)
Diarrhea
Systemic Sclerosis
Chronic Diarrhea
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2024-03-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

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

  * 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

Primary outcomes:
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).
timeFrame: The first week after treatment.
Secondary outcomes:
measure: Patient-reported treatment outcome on symptoms
timeFrame: The first week after treatment.
measure: Patient-reported measures from the schedule of side effects and telephone call 1 week after each intervention.
timeFrame: One week after each treatment
measure: Patient-reported outcomes from questionnaires.
timeFrame: At Baseline and 4 weeks after Intervention 1 & 2
measure: Patient-reported outcomes from questionnaires.
timeFrame: At Baseline and 4 weeks after Intervention 1 & 2
measure: Patient-reported outcomes from questionnaires.
timeFrame: At Baseline and 4 weeks after Intervention 1 & 2
measure: Patient-reported overall symptom burden
timeFrame: Each week for a total of 26 weeks.
measure: Objective measures from the wireless motility capsule.
timeFrame: At baseline
measure: Objective measures from the wireless motility capsule.
timeFrame: At baseline
measure: Objective measures from the wireless motility capsule.
timeFrame: At baseline
measure: Objective measures from the wireless motility capsule.
timeFrame: At baseline
measure: Objective measures from the low-dose CT scan.
timeFrame: At baseline and 4 weeks after first intervention
measure: Breath Test
timeFrame: At baseline and 4 weeks after first intervention
measure: Faecal microbiota composition
timeFrame: At baseline and between each treatment, up to 4 weeks after last intervention
measure: Faecal-calprotectin
timeFrame: At Baseline and 4 weeks after Intervention 1 & 2
measure: Blood plasma proteomics
timeFrame: At baseline and between each treatment, up to four weeks after last intervention.
measure: Blood plasma Fibrosis markers
timeFrame: At baseline and between each treatment, up to four weeks after last intervention.
measure: Blood parameters
timeFrame: At baseline and between each treatment, up to four weeks after last intervention.
measure: Health-related Quality of life
timeFrame: At baseline and 4 weeks after Intervention 1 & 2
measure: Patient perception of FMT treatment satisfaction
timeFrame: At 4 weeks after interventions 1 & 2
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
Study officials:
References: