Short summary

The main purposes of this randomised, double-blind, placebo-controlled, 12-month exploratory trial are to explore clinical efficacy aspects, safety, and patient acceptability associated with donor faecal microbiota transplantation performed in 200 patients with newly diagnosed untreated chronic inflammatory rheumatic, dermatological, gastrointestinal-,or pulmonary diseases.

Rationale

Humans are colonised by trillions of microorganisms residing on the epithelial surfaces. This complex aggregate of microorganisms comprises the human microbiota which is increasingly being recognised as a modulator of human health and disease. In particular, the gastrointestinal bacterial composition has been associated with the pathogenesis of autoimmune and inflammatory diseases. As a consequence, manipulation of the gut microbiota is currently being tested as a potential novel treatment for both chronic intestinal- and extra-intestinal diseases. To date, no studies have examined safety and clinical efficacy of FMT performed in patients with newly diagnosed, untreated chronic inflammatory diseases.

Description of the cohort

200 adults with a newly diagnosed untreated chronic disease (rheumatoid arthritis, reactive arthritis, ankylosing spondylitis, psoriatic arthritis, gouty arthritis, psoriasis, hidradenitis suppurativa, pulmonary sarcoidosis, Crohn's disease, or ulcerative Colitis) . 5 healthy stool donors who have passed an extensive screening programme.

Data and biological material

Clinical data, questionnaires/patient-reported outcomes, qualitative data, biological material (faeces, blood, urine).

Collaborating researchers and departments

Dept. of Rheumatology at Odense and Svendborg, Odense University Hospital (OUH), DK

Dept. of Medical Gastroenterology, OUH, DK

Dept. of Dermatology, OUH, DK

Dept. of Respiratory Medicine, OUH, DK

Dept. of Clinical Immunology, OUH, DK

Dept. of Clinical Physiology and Nuclear Medicine, OUH, DK