Safety and Efficacy of Capsule FMT in Treatment-naïve Patients With Newly Diagnosed Chronic Inflammatory Diseases

Launched by ODENSE UNIVERSITY HOSPITAL · Jun 7, 2021

Keywords

ClinConnect Summary

This clinical trial is investigating the safety and effectiveness of a treatment called capsule fecal microbiota transplant (cFMT) for patients who have recently been diagnosed with chronic inflammatory diseases, such as rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, pulmonary sarcoidosis, Crohn's disease, or ulcerative colitis. The trial aims to see if this treatment can help improve patients' health over a 12-month period, comparing results from those receiving cFMT to those receiving a placebo (a treatment that looks like the real one but has no active ingredients).

To be eligible for this trial, participants must be between 18 and 75 years old, newly diagnosed with one of the specified diseases, and have not yet started any other treatment for their condition. They will receive either the cFMT treatment or placebo once a week for the first month, alongside standard first-line medication as recommended for their specific condition. Throughout the trial, patients will undergo regular check-ups and complete health surveys to monitor their progress and any side effects. This study is currently recruiting participants and aims to provide valuable insights into new treatment options for these chronic conditions.

Gender

ALL

Eligibility criteria

• Inclusion criteria:
• • Newly diagnosis of treatment-naïve RA, AS, PsA, PSar, CD, or UC.
• • Treatment-naïve which is defined as no current or previous (within 3 months) disease-modifying anti-rheumatic drugs (DMARDs) or systemic anti-inflammatory treatment including glucocorticoids.
• • Presence of CID treatment indication (no contra-indications) and patient accept to start first-line standard treatment in accordance with the national guideline for the specific diagnosis following the baseline visit.
• • Age 18 to 75 years.
• Exclusion criteria:
• • Indication for biological therapy as primary therapy.
• • Celiac disease or food allergy.
• • Current cancer.
• • Hepatitis B and C, HIV, HTLV1/2, and active TB or other serious chronic infections.
• • Pregnant or breastfeeding women.
• • Not wishing to participate or not suited for FMT intervention or project evaluation.