Gut Microbiota Transplantation in Systemic Sclerosis

Summary

Systemic Sclerosis (SSc) is a progressive multi-organ disorder with high disease burden. Life expectancy in SSc is reduced by 25-40 years, mainly due to cardiopulmonary and gastro-intestinal (GI) disease involvement; and a very poor response to available treatment. Aiming to improve treatment for SSc, the ReSScue project will determine the therapeutic potential of standardized, cultivated gut microbiome transplantation (GMT), and assess the mechanisms by which this novel intervention strategy works. This approach is rationalized by studies indicating that skewed gut microbiomes could act as major, environmental risk factors in SSc; and thereby be rational targets for therapeutic manipulation. ReSScue is set up as a 4 months randomized double blind trial involving the University Hospital in Oslo. Trial participants will be recruited from the population-based, nationwide SSc cohort. Intervention will be by GMT or placebo. Primary end point is changes in SSc-related GI parameters , while secondary outcomes include safety, explorative clinical parameters, changes in oral, skin and gut microbiomes, and in immune cell phenotypes.

Timeline

Start

2018-01-18

Primary completion

2018-05-18

Completion

2018-10-15

Publications

• Strahm N, Didriksen H, Fretheim H, Molberg O, Midtvedt O, Farstad IN, Midtvedt T, Lundin KEA, Aabakken L, Blyszczuk P, Distler O, Kania G, Hoffmann-Vold AM. Effects of faecal microbiota transplantation on the small intestinal mucosa in systemic sclerosis. Rheumatology (Oxford). 2023 Aug 1;62(8):2918-2929. doi: 10.1093/rheumatology/kead014.

Drugs

Indications