Donor Versus Autologous Fecal Microbiota Transplantation for Axial Spondyloarthritis: a Double Blind, Placebo-Controlled, Randomized Trial

What this Trial Is About

Researchers are investigating fecal microbiota transplantation (FMT) as a possible treatment for patients with axial Spondyloarthritis (axSpA) who have not had full relief from biologic therapies. AxSpA is a chronic inflammatory disease affecting the spine and sacroiliac joints, often linked to gut inflammation and an imbalance of gut microbes. This randomized, double-blind study aims to see if FMT can reduce disease activity, pain, and fatigue, and restore normal gut microbiota in these patients. Participants will receive a single enema treatment at the start of the study with either donor fecal microbiota or a placebo consisting of their own feces. The active treatment involves 60 grams of feces from a screened healthy donor mixed with glycerol and saline in a 440 ml enema. The placebo treatment is prepared similarly but uses the participant's own stool. The study will monitor participants for efficacy and safety from baseline up to 365 days, with the primary assessment point at 90 days. During the study, participants will undergo several evaluations including disease activity scores, pain and fatigue assessments, and quality of life questionnaires at various intervals from baseline through one year. Safety and adverse events will be closely monitored throughout. The main outcome is the minimal clinically important improvement measured at 90 days. This comprehensive follow-up will help determine the potential benefits and safety of FMT in managing axial SpA symptoms.

Fecal Microbiota Transplantation in Axial Spondyloarthritis