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Fecal Microbiota Transplantation in Axial Spondyloarthritis

NCT06451588 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2024-06-11

No results posted yet for this study

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.

Conditions

Interventions

DRUG

FMT

Active FMT

DRUG

Placebo

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

Sponsors & Collaborators

  • Helse Nord

    collaborator INDUSTRY

  • University Hospital of North Norway

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-01
Primary Completion
2025-05-31
Completion
2026-03-31

Countries

  • Norway

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06451588 on ClinicalTrials.gov