Beneficial outcomes of FMT.
gastrointestinal complaints, UC
ULCERATIVE COLITIS, ADVERSE EVENTS, ADVERSE EVENT, ADVERSE EVENT, REMISSION, EVENTS
Between June 2016 and June 2019, 22 patients with active UC were recruited and assessed for eligibility. Enrolled patients received capsulized FMT treatment and completed the final follow-up at week 12. During the follow-up visits, one patient failed the screening process and was thus excluded. The clinical trial protocol is shown in Effect of fecal microbiota transplantation on 12-week remission in patients with ulcerative colitis. (A) Trial profile of fecal microbiota transplantation in patients with ulcerative colitis; (B) time points for obtaining fecal samples (triangles), clinical evaluation by Mayo scoring (diamonds), and colonoscopy (circles) during this clinical trial. Shown are changes in endoscopy and hematoxylin-eosin staining (C) and Mayo scores (D) for UC patients before and after treatment with FMT. The parallel line shows the change in Mayo score for individual patients, with a solid line indicative of values for FMT. Each line started at the baseline (W0 [circle]) and finished at its endpoint (W12 [triangle]). The achievement of clinical remission is indicated in green, and nonclinical remission is shown in red. Asterisks in in box plots represent the mean Mayo scores of each group. The significance was determined by paired Wilcoxon rank sum test. FMT, oral capsulized fecal microbiota transplantation.Baseline characteristics of patients with UC and the outcomes after treatment by FMTCRP, C-reactive protein; ESR, erythrocyte sedimentation rate; WBC count, white blood cell count.The efficacy analysis included 21 patients, excluding 1 patient who lost communication during the study.Over the 12-week study, a significant reduction in the total Mayo score was observed compared to the baseline. The patients who achieved a Mayo score with a ≥3-point reduction and a reduction of ≥30% at week 12 were considered responders (Rps). The patients who achieved a Mayo score of ≤2 at week 12 were considered to be in clinical remission (Rm). At the baseline, there were no significant differences in the total Mayo score between responders (Rps) and nonresponders (NRps) or patients in the remission (Rm) and nonremission (NRm) stages. The mean total Mayo score significantly (Satisfactorily, no serious adverse events occurred during the study period, and capsulized FMT treatment was well tolerated. The most frequently occurring adverse events were gastrointestinal complaints, including increased bowel movements (Adverse events during the 12-week studyAE, adverse event; SAEs, serious adverse events.Data are number of events or number of patients with percentage shown in parentheses.Laboratory tests of UC patients during FMT treatmentRm group, patients in clinical remission; NRm group, patients in the nonremission stage; W1, W4, and W12, weeks 1, 4, and 12, respectively; CRP, C-reactive protein; ESR, erythrocyte sedimentation rate; WBC count, white blood cell count.