Trial Report Randomized, double-blinded, placebo-controlled pilot study: efficacy of faecal microbiota transplantation on chronic fatigue syndrome, 2023, Salonen+

Randomized, double-blinded, placebo-controlled pilot study: efficacy of faecal microbiota transplantation on chronic fatigue syndrome
Salonen, Tapani; Jokinen, Elina; Satokari, Reetta; Lahtinen, Perttu

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.

Link | PDF (Journal of Translational Medicine)

 

"In diagnosing CFS, the Institute of Medicine (IOM) criteria were applied"

 

I have trouble quoting the pdf, but it seems like the trial was open to being a little larger, but over half (17/29) of the patients who qualified rejected the opportunity due to severe fatigue and unwillingness to have the procedure.

There are couple ways to do this, via colonoscopy, pill or probe. The authors thought colonoscopy had the highest chance of success (they reference it being superior in an IBS study) but patients, I think understandably deemed it too "burdensome".

This selection bias against the more severely ill patients, and possibly not using the CCC, led to higher than usual fatigue scores in both groups. Higher scores here meant less symptomatic.

I would've liked to see some outcomes for gut related symptoms, but otherwise it looks like a good study, and short enough even for me!