Short summary

The purpose of this randomised, double-blind, placebo-controlled, 3 month trial is to investigate the clinical efficacy, safety, and patient-reported quality of life as well as impact on colonic microbiome associated with donor faecal microbiota transplantation (FMT) in 40 patients with acute uncomplicated diverticulitis

Rationale

Acute diverticulitis a common condition encountered by surgeons in the acute setting, however, the aetiology remains incompletely understood. Recent research is investigating whether dysbiosis of the colonic microbiota can lead to the development of diverticulitis. At the moment, there is no treatment with convincing clinical evidence, so the identification of a new treatment modality is essential. Fecal microbiota transplantation (FMT) is a safe and effective strategy to restore a healthy diversity of the gastrointestinal microbiota and restore balance in patients with recurrent Clostridioides difficile infections, and this manipulation of the gut microbiota is being tested in various other diseases. This is the first time the efficacy and safety of FMT in patients with acute uncomplicated diverticulitis is being investigated.

Description of the cohort

Patients with acute uncomplicated diverticulitis, as confirmed by CT scan, will be recruited from the Surgical Department at Odense University Hospital (Odense/Svendborg) and randomly assigned to either the intervention group or control group. The intervention group consists of 20 patients receiving encapsulated FMT, and the control groups consists of 20 patients receiving placebo capsules, with isotonic saline. 1-3 healthy stool donors who have passed a screening programme.

Data and biological material

biological material (faces, blood, urine), qualitative data, questionnaires/patient reported outcomes, clinical data, demographics

Collaborating researchers and departments

Department of Rheumatology, Odense University Hospital, Odense, Denmark

Department of Medical Gastrointestinal Diseases, Odense University Hospital, Odense, Denmark

Department of Surgery, Odense University Hospital, Odense/Svendborg, Denmark

Department of Clinical Immunology, Odense University Hospital, Odense, Denmark