Safety and Efficacy of Anaerobic Cultivated Human Intestinal Microbiome Transplantation in Systemic Sclerosis (ReSScue)
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Systemic Sclerosis
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: The 20-week study period consists of a 12-week induction phase (Part A1), with randomized, double-blind parallel group interventions by endoscopic infusions at weeks 0 and 2, and an 8-week maintenance phase (Part A2) where all participants receive one single open label endoscopic infusion on week 12. Additionally, all participants who complete the 20-week study period are followed for a maximum 16 weeks monitoring period (Part B) to obtain longer-term data on safety and durability of intervention effects.Masking: Triple (Participant, Investigator, Outcomes Assessor)Masking Description: Masking will apply for the whole duration of study until end of study defined as week 20 visit for the last participant.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 85 years
- Gender
- Both males and females
Description
Not Provided
Not Provided
Tracking Information
- NCT #
- NCT04300426
- Collaborators
- South-Eastern Norway Regional Health Authority
- Haukeland University Hospital
- St. Olavs Hospital
- University Hospital of North Norway
- Investigators
- Principal Investigator: Anna-Maria Hoffmann-Vold, MD, PhD Oslo University Hospital
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