Faecal Microbiota Transplantation Against Chronic Diarrhea in Patients With Systemic Sclerosis (FaeMiCue)

University of Aarhus

Status: Not yet enrolling

Conditions: Diarrhea; Systemic Sclerosis

Treatments: Procedure: Faecal Microbiota Transplantation (FMT); Procedure: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06333795

1-10-72-131-23

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups, including a placebo group

Active treatment

Experimental group

Description:

Active capsule FMT-treatment

Treatment:

Procedure: Faecal Microbiota Transplantation (FMT)

Placebo

Placebo Comparator group

Description:

Placebo capsules are given.

Treatment:

Procedure: Placebo