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RECRUITING
NCT06451588
PHASE2

Fecal Microbiota Transplantation in Axial Spondyloarthritis

Sponsor: University Hospital of North Norway

View on ClinicalTrials.gov

Summary

Although biologic therapy have revolutionized the treatment of Spondyloarthrtitis (SpA), many patients do not experience complete relief of SpA related complaints. It has been established that patients with SpA have an altered composition of microorganisms (microbiota) in the gut compared to healthy controls, and that this correlates to disease activity and respons to therapy. The goal of this randomized double-blind study is to evaluate the efficacy of fecal microbiota transplantation (FMT) in patients with axial SpA with a suboptimal effect of biologic therapy. The main questions it aims to answer are: * Can FMT reduce disease activity in axial SpA? * Can FMT alleviate pain and reduce fatigue in axial SpA? * Is the composition of microorganisms restored to normal in patients with SpA after a treatment with FMT? Participants will receive a single treatment in the form of an enema with either donor FMT or placebo at baseline. The primary endpoint will be evaluated after 90 days, but efficacy and safety will be monitored from baseline until 365 days.

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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

99

Start Date

2024-06-01

Completion Date

2026-03

Last Updated

2024-06-11

Healthy Volunteers

No

Interventions

DRUG

FMT

Active FMT

DRUG

Placebo

The placebo treatment will be prepared based on the patients' fecal samples (autologous).

Locations (1)

University Hospital North Norway

Tromsø, Norway