Systemic sclerosis & Raynaud's
Faecal microbiota transplantation in patients with systemic sclerosis and lower gastrointestinal tract symptoms in Norway (ReSScue): a phase 2, randomised, double-blind, placebo-controlled trial
Primary result · Change in worst lower GI tract symptomResult — go to the resultAverage marginal effect 0.20 95% CI −0.12 to 0.52Authors' conclusion
Faecal microbiota transplantation with ACHIM was well tolerated in participants with systemic sclerosis but did not result in an improvement in lower gastrointestinal tract symptoms.
Study context
- Population
- Adults aged 18–85 years with SSc and moderate-to-severe lower gastrointestinal tract symptoms (bloating or diarrhoea), four university hospitals in Norway62 (93%) women
- Participants
- 67 adults
- Comparison
- FMT with anaerobic cultivated human intestinal microbiome (ACHIM) vs placebo
- ACHIMn = 33
- Placebon = 34reference
- Primary endpoint
- Change in worst lower gastrointestinal tract symptom (bloating or diarrhoea), UCLA SCTC GIT 2.0 scoring system
- Follow-up
- Week 0 to week 12
Methodological detailsphase 2, double-blind, placebo-controlled, multicentre (four university hospitals), stratified by worst symptom, A person with lived experience of SSc was involved in study planning and conduct
- Phase 2
- Double-blind
- Placebo-controlled
- Multicentre (four university hospitals)
- Stratified by worst symptom
- A person with lived experience of SSc was involved in study planning and conduct
Primary result
Change in worst lower GI tract symptom
Average marginal effect
0.20
95% CI −0.12 to 0.52
P = 0.22
Change by group
ACHIM
−0.13
95% CI −0.37–0.11
Placebo
−0.33
95% CI −0.57–-0.09
As reported in the abstract
Safety
Adverse events (mostly mild and short-lived GI tract symptoms)
Duodenal perforation during gastroscopy
- One participant had a duodenal perforation
- 1
Original publication
Faecal microbiota transplantation in patients with systemic sclerosis and lower gastrointestinal tract symptoms in Norway (ReSScue): a phase 2, randomised, double-blind, placebo-controlled trial. Lancet Rheumatol. Published 31 January 2025. doi:10.
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