Study design.
UC
We conducted a single-arm pilot clinical trial by enrolling 22 patients with active UC between June 2016 and June 2019 at Zhongshan Hospital in Xiamen University. Nine donors were included in the study, and their stool was extracted and filled into capsules. To increase microbial diversity, every patient randomly received FMT infusions from two or three donors. Patients underwent three capsulized FMT procedures (one every 2 days) within a week. After 12 weeks of follow-up visits, clinicians assessed the effect of FMT on UC patients. Maintenance therapy involved the administration of a stable dose (prior to enrollment) of 5-ASA/SASP (salicylazosulfapyridine) and prednisone that was mandatorily tapered to 5 mg (>10 mg/day) or 2.5 mg (≤10 mg/day) per week. Stool samples of patients with UC were collected at weeks 0, 1, 4, and 12 for microbiome analysis, and blood samples were collected for laboratory examination and metabolomic analysis. This study was approved by the Zhongshan Hospital of Xiamen University and was registered at ClinicalTrials.gov (registration no. NCT03426683).