Intest Res.  2019 Jan;17(1):78-86. 10.5217/ir.2018.00089.

Efficacy of fecal microbiota therapy in steroid dependent ulcerative colitis: a real world intention-to-treat analysis

• Sood A
• Mahajan R
• Juyal G
• Midha V
• Grewal CS
• Mehta V
• Singh A
• Joshi MC
• Narang V
• Kaur K
• Sidhu H

• KMID: 2438446
• DOI: http://doi.org/10.5217/ir.2018.00089

Abstract

BACKGROUND/AIMS
Four high-quality randomized controlled trials have proven the efficacy of fecal microbiota transplantation (FMT) in active ulcerative colitis (UC). We assessed the efficacy of FMT in a real-world setting involving steroid-dependent patients with UC.
METHODS
This was a single-center prospective analysis of data from steroid-dependent patients with UC treated with FMT from September 2015 to September 2017 at the Dayanand Medical College, a tertiary care center in India. Fecal samples from random unrelated donors were administered through colonoscopy at weeks 0, 2, 6, 10, 14, 18, and 22. The primary outcome was achievement of steroid-free clinical remission, and the secondary outcomes were clinical response and endoscopic remission at 24 weeks. Modified intention-to-treat analysis was performed, which included subjects who underwent at least 1 FMT.
RESULTS
Of 345 patients with UC treated during the study period, 49 (14.2%) had steroid-dependent UC. Of these 49 patients, 41 underwent FMT: 33 completed 7 sessions over 22 weeks according to the protocol, and 8 discontinued treatment (non-response, 5; lost to follow-up, 2; and fear of adverse effects, 1). At week 24, steroid-free clinical remission was achieved in 19 out of 41 (46.3%) patients, whereas clinical response and endoscopic remission were achieved in 31 out of 41 (75.6%) and 26 out of 41 (63.4%) patients, respectively. All patients with clinical response were able to withdraw steroids. There were no serious adverse events necessitating discontinuation.
CONCLUSIONS
A multisession FMT via the colonoscopic route is a promising therapeutic option for patients with steroid-dependent UC, as it can induce clinical remission and aid in steroid withdrawal.

Keyword

Fecal microbiota transplantation; Colitis, ulcerative; Real world analysis

MeSH Terms

Colitis, Ulcerative*
Colonoscopy
Fecal Microbiota Transplantation
Humans
India
Lost to Follow-Up
Microbiota*
Prospective Studies
Steroids
Tertiary Care Centers
Ulcer*
Unrelated Donors
Steroids

Figure

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  Fig. 1. Patient flow diagram. FMT, fecal microbiota transplantation.

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  Fig. 2. Clinical outcomes in patients who completed 7 cycles of FMT (n=33). (A) Line diagram showing trend of Mayo score. (B) Line diagrams showing primary and secondary outcomes. (C) Line diagram showing trend of slurry retention time.

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