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Randomized Controlled Trial
. 2023 May 7;29(17):2666-2678.
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  1   2 , Jonna Jalanka  3 , Eero Mattila  4 , Jyrki Tillonen  1 , Paula Bergman  5 , Reetta Satokari  3 , Perttu Arkkila  6
Affiliations
Randomized Controlled Trial

Fecal microbiota transplantation for the maintenance of remission in patients with ulcerative colitis: A randomized controlled trial

Perttu Lahtinen et al. World J Gastroenterol. .

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

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Conflict of interest statement

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.

Figures

Figure 1
Figure 1
Kaplan-Meier survival curve demonstrating the maintenance of remission defined as fecal calprotectin < 200 μg/g and the clinical Mayo score < 3 or an overt relapse in between the measurement points. A: All patients included in analysis (log rank test P = 0.660); B: Subgroup A, i.e. the patients with fecal calprotectin < 200 μg/g and clinical Mayo score < 3 at the baseline (P = 0.703); C: Subgroup B, i.e. the patients with fecal calprotectin ≥ 200 μg/g or the clinical Mayo score ≥ 3 at the baseline (P = 0.556). Censored means the end of follow-up without a relapse. FMT: Fecal microbiota transplantation.
Figure 2
Figure 2
The general quality of life of the complete study group shown according to the 15 dimensions and the mean total score and P value as expressed numerically within the picture. A: The total score of the 15 dimensions quality of life questionnaire (15D) profiles at the baseline (n = 48); B: 15D profiles at 12 mo (n = 21); C: 15D profiles at 4 mo (n = 30). aP ≤ 0.05 and bP ≤ 0.01. FMT: Fecal microbiota transplantation; 15D: The total score of the 15 dimensions quality of life questionnaire.
See this image and copyright information in PMC

References

    1. Ungaro R, Mehandru S, Allen PB, Peyrin-Biroulet L, Colombel JF. Ulcerative colitis. Lancet. 2017;389:1756–1770. - PMC - PubMed
    1. Jussila A, Virta LJ, Kautiainen H, Rekiaro M, Nieminen U, Färkkilä MA. Increasing incidence of inflammatory bowel diseases between 2000 and 2007: a nationwide register study in Finland. Inflamm Bowel Dis. 2012;18:555–561. - PubMed
    1. Lamb CA, Kennedy NA, Raine T, Hendy PA, Smith PJ, Limdi JK, Hayee B, Lomer MCE, Parkes GC, Selinger C, Barrett KJ, Davies RJ, Bennett C, Gittens S, Dunlop MG, Faiz O, Fraser A, Garrick V, Johnston PD, Parkes M, Sanderson J, Terry H IBD guidelines eDelphi consensus group, Gaya DR, Iqbal TH, Taylor SA, Smith M, Brookes M, Hansen R, Hawthorne AB. British Society of Gastroenterology consensus guidelines on the management of inflammatory bowel disease in adults. Gut. 2019;68:s1–s106. - PMC - PubMed
    1. Haapamäki J, Roine RP, Sintonen H, Turunen U, Färkkilä MA, Arkkila PE. Health-related quality of life in inflammatory bowel disease measured with the generic 15D instrument. Qual Life Res. 2010;19:919–928. - PubMed
    1. Manichanh C, Borruel N, Casellas F, Guarner F. The gut microbiota in IBD. Nat Rev Gastroenterol Hepatol. 2012;9:599–608. - PubMed

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