Study on Fecal Microbiota Transplantation for Patients with Axial Spondyloarthritis Resistant to Conventional Treatment

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What is this study about?

This clinical trial is focused on studying the effects of a treatment called Fecal Microbiota Transplantation (FMT) in patients with axial spondyloarthritis. Axial spondyloarthritis is a type of arthritis that primarily affects the spine and the joints connecting the spine to the pelvis, causing pain and stiffness. The study aims to explore whether FMT can help improve the condition of patients who have not responded well to conventional treatments. FMT involves transferring healthy bacteria from the stool of a donor into the patient’s gut to restore a balanced microbiome, which is the community of microorganisms living in the intestines.

Participants in the study will receive either the FMT treatment or a placebo, which is a capsule that looks like the treatment but contains no active ingredients. The FMT treatment is given in the form of a prolonged-release capsule called MaaT033, which contains pooled allogeneic fecal microbiota. The study will also use a product called MOVIPREP, an osmotic laxative that helps clear the intestines, to prepare participants for the FMT procedure. MOVIPREP is an oral solution containing ingredients like ascorbic acid (vitamin C), sodium ascorbate, potassium chloride, sodium chloride, sodium sulfate anhydrous, and macrogol 3350.

The trial will last for several months, during which participants will be monitored to assess the effectiveness of FMT in improving their symptoms. The study will compare the results of those receiving the FMT treatment with those receiving the placebo to determine if there is a significant difference in outcomes. The goal is to see if FMT can correct an imbalance in gut bacteria and improve the clinical condition of patients with axial spondyloarthritis.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria, including age, diagnosis, and current treatment status.

Written informed consent is required to participate in the study.

2 baseline assessment

Initial assessments are conducted to establish baseline measurements. This includes evaluating the current state of the condition and any ongoing treatments.

3 treatment phase

Participants receive either the MaaT033 treatment or a placebo. MaaT033 is administered as a prolonged-release capsule taken orally.

The treatment aims to replace existing microbiota with healthier microbiota to address the condition.

4 monitoring and follow-up

Participants are monitored at various intervals: Day 28, Day 42, Day 84, and Day 168.

Assessments include clinical evaluations and measurements of microbiota changes.

5 end of study

The study concludes with a final assessment to evaluate the overall impact of the treatment.

Participants’ progress and any changes in their condition are documented.

Who Can Join the Study?

Adult patient aged between 18 to 75 years old with a diagnosis of axial spondyloarthritis (SpA) for at least 6 months. This condition affects the spine and sometimes other joints.
Patient must meet specific criteria for axial SpA, which may include having or not having visible changes in the spine on X-rays.
Patient experiencing active symptoms of SpA, with or without current treatment, and having a BASDAI score of 4 or higher. This score measures the severity of symptoms on a scale from 0 to 10.
Patient must have a back pain score of 4 or higher, despite having tried at least two different NSAIDs (non-steroidal anti-inflammatory drugs) at the highest dose they can tolerate for at least 2 months, unless they cannot take them due to side effects or other reasons.
Patient must have tried at least one type of biotherapy (such as anti-TNFα or anti-IL-17) or a JAK inhibitor for at least 4 months, unless they cannot take them due to side effects or other reasons.
Patient can continue taking certain medications like oral NSAIDs, methotrexate, hydroxychloroquine, or corticosteroids, as long as the dose has not changed for 4 weeks before joining the study.
Patient can continue taking anti-TNFα, anti-IL-17, or JAK inhibitor therapies, as long as the dose has not changed for 3 months before joining the study.
Women who can have children must use effective birth control at the start of the study and during the main part of the study.
Patient must have health insurance, except for a specific type called AME.
Patient must be willing to sign a document agreeing to participate in the study and follow the study rules.

Who Cannot Join the Study?

Patients who have any other serious health conditions that could interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have had a recent infection or are currently taking antibiotics.
Patients who have a history of severe allergies, especially to medications.
Patients who have participated in another clinical trial recently.
Patients who have a history of alcohol or drug abuse.
Patients who have had a major surgery recently.
Patients who have a compromised immune system, meaning their body’s defense system is weakened.
Patients who are unable to follow the study procedures or instructions.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Hopital Beaujon	Clichy	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	01.03.2024

Trial locations

Investigated drugs:

FMT (Fecal Microbiota Transplantation) is a therapy being studied for its potential to help patients with axial spondyloarthritis who have not responded to conventional treatments. This therapy involves transferring healthy microbiota from a donor to the patient, with the aim of correcting imbalances in the patient’s gut bacteria. The goal is to replace the existing dysbiotic (unhealthy) microbiota with healthier ones, which may improve the patient’s condition.

Investigated diseases:

Axial spondyloarthritis

Axial Spondyloarthritis – Axial spondyloarthritis is a type of inflammatory arthritis that primarily affects the spine and the joints connecting the spine to the pelvis. It often begins with pain and stiffness in the lower back and buttocks, which can progress to other parts of the spine. Over time, the inflammation can lead to the fusion of the vertebrae, resulting in reduced flexibility and mobility. The disease can also cause fatigue and may affect other areas of the body, such as the eyes and skin. Symptoms can vary in intensity and may come and go, with periods of increased activity followed by times of remission.

Trial ID:

2023-504852-89-00

Protocol code:

APHP220934

NCT ID:

NCT05654753

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Fecal Microbiota Transplantation for Patients with Axial Spondyloarthritis Resistant to Conventional Treatment

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?