The Efficacy of Fecal Microbiota Transplatation on Axial Spondyloarthritis Patients Resistant to Conventional Treatment

PHASE2/PHASE3RecruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

March 28, 2024

Primary Completion Date

September 30, 2027

Study Completion Date

September 30, 2027

Conditions
Axial Spondyloarthritis
Interventions
DRUG

active FMT

MaaT033®, a lyophilized full-ecosystem intestinal microbiota delayed release oral capsule containing native, donor-derived (pooled from 4-6 donors) microbiome product manufactured by MaaT Pharma® will be delivered orally. Patients will receive 20 Maat033 capsules, each containing approximatively 0.42 g of microbiome product at once at day 0, then 3 capsules/day from day 1 through day 20.

DRUG

Placebo

Patients will receive 20 capsules placebo, each containing placebo at once at day 0, then 3 capsules/day from day 1 through day 20.

Trial Locations (1)

92100

RECRUITING

Rheumatology Department, Ambroise Paré hospital - APHP, Boulogne-Billancourt

All Listed Sponsors
collaborator

Fondation Arthritis & Clarins Worldwide 2016

UNKNOWN

lead

Assistance Publique - Hôpitaux de Paris

OTHER