Randomized Controlled Trial
Copyright ©The Author(s) 2023. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. May 7, 2023; 29(17): 2666-2678
Published online May 7, 2023. doi: 10.3748/wjg.v29.i17.2666
Fecal microbiota transplantation for the maintenance of remission in patients with ulcerative colitis: A randomized controlled trial
Perttu Lahtinen, Jonna Jalanka, Eero Mattila, Jyrki Tillonen, Paula Bergman, Reetta Satokari, Perttu Arkkila
Perttu Lahtinen, Jyrki Tillonen, Department of Gastroenterology, Päijät-Häme Central Hospital, Lahti 15610, Finland
Perttu Lahtinen, Department of Medicine, University of Helsinki, Helsinki 00014, Finland
Jonna Jalanka, Reetta Satokari, Human Microbiome Research Program, Faculty of Medicine, University of Helsinki, Helsinki 00014, Finland
Eero Mattila, Department of Infectious Diseases, Helsinki University Hospital, Helsinki 00029, Uusimaa, Finland
Paula Bergman, Department of Bioinformatics, Helsinki University Hospital, Helsinki 00014, Finland
Perttu Arkkila, Department of Gastroenterology, University Helsinki, Center Hospital, Helsinki 00029, Uusimaa, Finland
Author contributions: Lahtinen P wrote the paper; Lahtinen P and Bergman P analyzed the data and designed the figures; Arkkila P, Satokari R, and Mattila E planned the study; Arkkila P, Satokari R, Lahtinen P, and Tillonen J executed the study and collected most of the data; Arkkila P, Lahtinen P, and Tillonen J assessed the colonoscopies; Satokari R administered fecal banking and FMT treatments; Jalanka J, Mattila E, and Tillonen J provided expertise in the study design and components of the article; All authors contributed to drafting the article and revised the manuscript for important intellectual content; All authors had access to the study data and reviewed and approved the final manuscript.
Supported by Academy of Finland (Reetta Satokari), No. 323156; Sigrid Juselius Foundation and University of Helsinki (A Three-year Grant); The Competitive State Research Financing (Perttu Lahtinen), No. 200230042; The Ella and Georg Ehrnrooth Foundation (Perttu Arkkila).
Institutional review board statement: The study was reviewed and approved by the Helsinki University Hospital Institutional Review Board, No. 29/13/03/01/2014.
Clinical trial registration statement: This study is registered at ClinicalTrials.gov. The registration identification number is NCT03561532.
Informed consent statement: All study participants or their legal guardian provided informed written consent about personal and medical data collection prior to study enrolment.
Conflict-of-interest statement: Dr. Lahtinen reports grants from The Competetive State Research Financing, grants from Academy of Finland, grants from Sigrid Juselius Foundation, grants from University of Helsinki, grants from Ella and Georg Ehrnrooth Foundation, during the conduct of the study.
Data sharing statement: The datasets generated and analyzed during the current study are not publicly available because individual privacy could be compromised. However, they are available from the corresponding author on reasonable request.
CONSORT 2010 statement: The authors have read the CONSORT 2010 statement, and the manuscript was prepared and revised according to the CONSORT 2010 statement.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Perttu Lahtinen, MD, Chief Doctor, Department of Gastroenterology, Päijät-Häme Central Hospital, Keskussairaalankatu 7, Lahti 15610, Finland. perttu.lahtinen@phhyky.fi
Received: December 27, 2022
Peer-review started: December 27, 2022
First decision: January 22, 2023
Revised: February 6, 2023
Accepted: April 11, 2023
Article in press: April 11, 2023
Published online: May 7, 2023
Processing time: 130 Days and 11 Hours
ARTICLE HIGHLIGHTS
Research background

Ulcerative colitis (UC) is associated with altered gut microbiota. The pathophysiology of UC is thought to involve an altered and exaggerated inflammatory response to commensal bacteria. Fecal microbiota transplantation has yielded good results in the induction of UC remission.

Research motivation

Despite the development in medications for UC, some patients do not respond sufficiently to current treatment options and new treatment modalities are needed. Modulation of gut microbiota via fecal microbial transplantation (FMT) is a potential new treatment option for UC patients.

Research objectives

The goal of this trial was to gather information of the role of gut microbiota in maintenance of remission in UC patients, and the aim was to investigate FMT for the maintenance of UC remission.

Research methods

Forty-eight patients with quiescent UC were randomized 1:1 to receive a single FMT via colonoscopy or a placebo made from the patient’s own stool. The patients were followed for 12 mo, and colitis symptoms were measured as well as fecal calprotectin. As secondary endpoints, quality of life, blood chemistry, and endoscopic findings at 12 mo were measured.

Research results

UC remission was maintained by 13 out of 24 (54%) patients in the FMT group and by 10 out of 24 (41%) patients in the placebo group (log-rank test, P = 0.660). The quality of life was lower in the FMT group at 4 mo after FMT as compared to the placebo group (P = 0.017). There were no differences in blood chemistry, fecal calprotectin, or endoscopic findings at 12 mo between the groups.

Research conclusions

There were no significant differences in the maintenance of remission between the groups during the 12-mo follow-up. Thus, our results do not support the use of a single-dose FMT for the maintenance of remission in UC patients.

Research perspectives

Many open questions need to be answered before we can determine whether FMT may be applied for the maintenance of remission in UC. We do not yet know which stool components distribute the positive effects of FMT. More research is needed to define the optimal donor characteristics, patient population, and the optimal number and timing of FMT treatments.