Role of Fecal Microbiota Transplantation for Maintenance of Remission in Patients with Ulcerative Colitis: A Pilot Study.
J Crohns Colitis. 2019 Mar 11;:
Authors: Sood A, Mahajan R, Singh A, Midha V, Mehta V, Narang V, Singh T, Pannu AS
OBJECTIVES: To study the role of fecal microbiota transplantation (FMT) in maintenance of remission in ulcerative colitis (UC).
METHODS: In this pilot study, patients with UC in clinical remission after multi-session FMT were randomly allocated to either maintenance FMT or placebo colonoscopic infusion every 8 weeks, for 48 weeks. The standard of care (SOC) therapy was continued in all patients. The primary end point was maintenance of steroid-free clinical remission (Mayo score ≤2, all sub scores ≤ 1) at week 48. Secondary end points were achievement of endoscopic remission (endoscopic Mayo score 0) and histological remission (Nancy grade 0, 1) at week 48.
RESULTS: Sixty one patients in clinical remission were randomized to receive either FMT n=31) or placebo (n=30). The primary outcome was achieved in 27/31 (87.1%) patients allocated FMT versus 20/30 (66.7%) patients assigned placebo (p=0.111). Secondary end points of endoscopic remission [FMT: 18/31 (58.1%) versus placebo: 8/30 (26.7%), p=0.026] and histological remission [FMT: 14/31 (45.2%) versus placebo: 5/30 (16.7%), p=0. 033] were achieved in significantly higher number of patients with FMT. Three patients receiving FMT (9.7%) and 8 patients on placebo (26.7%) relapsed. There were no serious adverse events necessitating discontinuation in patients on FMT, 1 patient who relapsed on placebo required colectomy.
CONCLUSIONS: Maintenance FMT in patients who are in clinical remission may help sustain clinical, endoscopic and histological remission in patients with UC. Keywords: Inflammatory Bowel Disease; Clinical remission; Endoscopic remission; Histological remission.
PMID: 30873549 [PubMed – as supplied by publisher]