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
Abstract
BACKGROUND

Fecal microbial transplantation (FMT) is a promising new method for treating active ulcerative colitis (UC), but knowledge regarding FMT for quiescent UC is scarce.

AIM

To investigate FMT for the maintenance of remission in UC patients.

METHODS

Forty-eight UC patients were randomized to receive a single-dose FMT or autologous transplant via colonoscopy. The primary endpoint was set to the maintenance of remission, a fecal calprotectin level below 200 μg/g, and a clinical Mayo score below three throughout the 12-mo follow-up. As secondary endpoints, we recorded the patient’s quality of life, fecal calprotectin, blood chemistry, and endoscopic findings at 12 mo.

RESULTS

The main endpoint was achieved 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). Four months after FMT, the quality-of-life scores decreased in the FMT group compared to the placebo group (P = 0.017). In addition, the disease-specific quality of life measure was higher in the placebo group than in the FMT group at the same time point (P = 0.003). There were no differences in blood chemistry, fecal calprotectin, or endoscopic findings among the study groups at 12 mo. The adverse events were infrequent, mild, and distributed equally between the groups.

CONCLUSION

There were no differences in the number of relapses between the study groups at 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.

Keywords: Fecal microbial transplantation; Ulcerative colitis; Quality of life; Maintenance of remission; Inflammatory bowel disease; Fecal calprotectin

Core Tip: This randomized controlled trial compared the efficacy of fecal microbial transplantation via colonoscopy and autologous placebo containing patients’ own feces for the maintenance of remission in 48 patients with ulcerative colitis. The colitis activity was measured with the clinical Mayo score and fecal calprotectin. There was no significant difference in relapses between the groups at the 12-mo follow-up. Remission remained in 54% of the patients in the fecal microbial transplantation group compared to 41% in the placebo group. There was no difference in the adverse events between the groups.