Randomized, double-blinded, placebo-controlled pilot study: efficacy of faecal microbiota transplantation on chronic fatigue syndrome

Journal of Translational Medicine · 4 authors, 4 centres

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Eleven patients (10 female, 1 male; mean age 42.2 years) with a mean CFS duration of 6.3 years were assigned to receive FMT from a universal donor (n=5) or autologous FMT (placebo, n=6) via colonoscopy. HRQOL was assessed at baseline, 1 month, and 6 months using visual analog scale (VAS), Modified Fatigue Impact Scale (MFIS), 15D, and EQ-5D-3L. The 15D and EQ-5D-3L profiles also remained unchanged after the procedure. FMT-related adverse events were not reported. The authors conclude that FMT was safe but did not relieve symptoms or improve HRQOL, noting that the small sample size limits generalizability.

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RCT

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gastroenterology

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ORIGINAL PAPER

PMC10386223

Randomized, double-blinded, placebo-controlled pilot study: efficacy of faecal microbiota transplantation on chronic fatigue syndrome

Journal of Translational Medicine

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ABSTRACT

Abstract Background Chronic fatigue syndrome (CFS) is a disabling illness of unknown aetiology. Disruption of gut microbiota may play a role in several neurological disorders. In this study, the effect of faecal microbiota transplantation (FMT) on fatigue severity and health-related quality of life (HRQOL) in patients with CFS was evaluated. Methods Randomized, placebo-controlled pilot trial. Patients and researchers were blinded to treatment assignment. 11 patients with CFS (10 female and 1 male, mean age 42.2 years and mean duration of CFS 6.3 years) were randomly assigned to receive either FMT from a universal donor (n = 5) or autologous FMT (n = 6) via colonoscopy. Patients’ HRQOL was assessed by using visual analog scale (VAS) and self-reporting questionnaires Modified Fatigue Impact Scale (MFIS), 15D and EQ-5D-3L. Patients’ HRQOL was evaluated at baseline, and 1 and 6 months after the FMT. Results The baseline VAS scores in the FMT and placebo groups were 62.4 and 76.0 (p = 0.29). 1-month scores were 60.0 and 73.7 and 6-months scores 72.8 and 69.5, respectively. Total MFIS scores in the FMT and placebo groups were 59.6 and 61.0 at the baseline (p = 0.80), 53.5 and 62.0 at 1 month and 58.6 and 56.2 at 6 months. Compared to the baseline scores, differences at 1 and 6 months were statistically insignificant both in VAS and in MFIS. The 15D and EQ-5D-3L profiles did not change after the FMT or placebo. FMT-related adverse events were not reported. Conclusion FMT was safe but did not relieve symptoms or improve the HRQOL of patients with CFS. Small number of study subjects limits the generalizability of these results. Trial Registration ClinicalTrials.gov Identifier NCT04158427 , https://register.clinicaltrials.gov , date of registration 08/08/2019. Keywords: Chronic fatigue syndrome, Health-related quality of life, Faecal microbiota transplantation

CITATION EXPORT

Tapani Salonen, Elina Jokinen, Reetta Satokari et al.. Randomized, double-blinded, placebo-controlled pilot study: efficacy of faecal microbiota transplantation on chronic fatigue syndrome. Journal of Translational Medicine. (2023). https://doi.org/10.1186/s12967-023-04227-y

AUTHORS

4 · 4 CENTRES

Tapani Salonen, Elina Jokinen, Reetta Satokari, Perttu Lahtinen

1Department of Medicine, Tampere University Hospital, BOX 2000, FIN, 33521 Tampere, Finland
2Department of Gastroenterology, Tampere University Hospital, Tampere, Finland
3Human Microbiome Research Program, Faculty of Medicine, University of Helsinki, Helsinki, Finland
4Department of Gastroenterology, Päijät-Häme Central Hospital, Lahti, Finland