World J Gastroenterol. 2023 May 7;29(17):2666-2678.doi: 10.3748/wjg.v29.i17.2666.

Perttu Lahtinen ^1 2, Jonna Jalanka ³, Eero Mattila ⁴, Jyrki Tillonen ¹, Paula Bergman ⁵, Reetta Satokari ³, Perttu Arkkila ⁶

Author information

¹Department of Gastroenterology, Päijät-Häme Central Hospital, Lahti 15610, Finland.

²Department of Medicine, University of Helsinki, Helsinki 00014, Finland. perttu.lahtinen@phhyky.fi.

³Human Microbiome Research Program, Faculty of Medicine, University of Helsinki, Helsinki 00014, Finland.

⁴Department of Infectious Diseases, Helsinki University Hospital, Helsinki 00029, Uusimaa, Finland.

⁵Department of Bioinformatics, Helsinki University Hospital, Helsinki 00014, Finland.

⁶Department of Gastroenterology, University Helsinki, Center Hospital, Helsinki 00029, Uusimaa, Finland.

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.