Faecal Microbiota Transplantation Against Chronic Diarrhea in Patients With Systemic Sclerosis

NCT06333795 | Active Not Recruiting

• 1 other identifier: 1-10-72-131-23
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Diarrhea; Systemic Sclerosis

Keywords

Faecal Microbiota Transplantation (FMT); Diarrhea; Systemic Sclerosis; Chronic Diarrhea

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (19)

• Patient-reported treatment outcome on symptoms

  The first week after treatment.

• Patient-reported measures from the schedule of side effects and telephone call 1 week after each intervention.

  One week after each treatment

• Patient-reported outcomes from questionnaires.

  At Baseline and 4 weeks after Intervention 1 & 2

• Patient-reported outcomes from questionnaires.

  At Baseline and 4 weeks after Intervention 1 & 2

• Patient-reported outcomes from questionnaires.

  At Baseline and 4 weeks after Intervention 1 & 2

Study Arms (2)

Active treatment

EXPERIMENTAL

Active capsule FMT-treatment

Procedure: Faecal Microbiota Transplantation (FMT)

Placebo

PLACEBO COMPARATOR

Placebo capsules are given.

Procedure: Placebo

Interventions

Faecal Microbiota Transplantation (FMT) PROCEDURE

Treatment is given as capsules.

Active treatment

Placebo PROCEDURE

Treatment is given as capsules.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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%

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Aarhus University Hospital

Aarhus, Denmark

Location

MeSH Terms

Conditions

Diarrhea; Scleroderma, Systemic

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study is blinded throughout the active study period, both the patient and investigator are blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, DMSc, PhD, Professor

Model Details: 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.

Study Record Dates

• First Submitted: March 5, 2024
• First Posted: March 27, 2024
• Study Start: April 1, 2024
• Primary Completion: January 21, 2026
• Study Completion: February 23, 2026
• Last Updated: March 4, 2026

Record last verified: 2026-03

Locations

DK (1)