Safety and Efficacy of Anaerobic Cultivated Human Intestinal Microbiome Transplantation in Systemic Sclerosis (ReSScue)
Status:
Recruiting
Trial end date:
2022-06-30
Target enrollment:
Participant gender:
Summary
This study evaluates the effect of intestinal microbiota therapy on gastro-intestinal
symptoms in patients with systemic sclerosis (SSc). This is a mulicenter randomized
controlled trial conducted at university hospitals in Oslo, Tromsø, Bergen and Trondheim in
Norway. In part A1, half of the patients will receive active substance (intestinal microbiota
cultured in the lab - "ACHIM") in the small intestine twice by gastroduodenoscopy, the other
half will receive placebo. The primary outcome will be measured on week 12 by patient
reported outcome measures. In part A2, all participants receive ACHIM at week 12, with an 8
week follow-up for all. A step-wise follow-up will be done in part B up to 16 weeks after
week 20 until the last participant finish week 20 visit, which is defined as end of study.The
blind from the first intervention will not be opened before end of study.
Phase:
Phase 2
Details
Lead Sponsor:
Oslo University Hospital
Collaborators:
Haukeland University Hospital South-Eastern Norway Regional Health Authority St. Olavs Hospital University Hospital of North Norway