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Clinical Trial
. 2024 Dec;22(12):2487-2496.e6.
doi: 10.1016/j.cgh.2024.06.004. Epub 2024 Jun 20.

Fecal Microbiota Transplantation for Sleep Disturbance in Post-acute COVID-19 Syndrome

Raphaela I Lau  1 , Qi Su  1 , Jessica Y L Ching  1 , Rashid N Lui  2 , Ting Ting Chan  2 , Marc T L Wong  2 , Louis H S Lau  2 , Yun Kwok Wing  3 , Rachel N Y Chan  3 , Hanson Y H Kwok  2 , Agnes H Y Ho  2 , Yee Kit Tse  4 , Chun Pan Cheung  5 , Moses K T Li  1 , Wan Ying Siu  1 , Chengyu Liu  1 , Wenqi Lu  1 , Yun Wang  1 , Emily O L Chiu  2 , Pui Kuan Cheong  2 , Francis K L Chan  6 , Siew C Ng  7
Affiliations
Clinical Trial

Fecal Microbiota Transplantation for Sleep Disturbance in Post-acute COVID-19 Syndrome

Raphaela I Lau et al. Clin Gastroenterol Hepatol. 2024 Dec.

Abstract

Background & aims: Post-acute COVID-19 syndrome (PACS) is associated with sleep disturbance, but treatment options are limited. The etiology of PACS may be secondary to alterations in the gut microbiome. Here, we report the efficacy of fecal microbiota transplantation (FMT) in alleviating post-COVID insomnia symptoms in a nonrandomized, open-label prospective interventional study.

Methods: Between September 22, 2022, and May 22, 2023, we recruited 60 PACS patients with insomnia defined as Insomnia Severity Index (ISI) ≥8 and assigned them to the FMT group (FMT at weeks 0, 2, 4, and 8; n = 30) or the control group (n = 30). The primary outcome was clinical remission defined by an ISI of <8 at 12 weeks. Secondary outcomes included changes in the Pittsburgh Sleep Quality Index, Generalized Anxiety Disorder-7 scale, Epworth Sleepiness Scale, Multidimensional Fatigue Inventory, blood cortisol and melatonin, and gut microbiome analysis on metagenomic sequencing.

Results: At week 12, more patients in the FMT than the control group had insomnia remission (37.9% vs 10.0%; P = .018). The FMT group showed a decrease in ISI score (P < .0001), Pittsburgh Sleep Quality Index (P < .0001), Generalized Anxiety Disorder-7 scale (P = .0019), Epworth Sleepiness Scale (P = .0057), and blood cortisol concentration (P = .035) from baseline to week 12, but there was no significant change in the control group. There was enrichment of bacteria such as Gemmiger formicilis and depletion of microbial pathways producing menaquinol derivatives after FMT. The gut microbiome profile resembled that of the donor in FMT responders but not in nonresponders at week 12. There was no serious adverse event.

Conclusions: This pilot study showed that FMT could be effective and safe in alleviating post-COVID insomnia, and further clinical trials are warranted.

Clinicaltrials: gov, Number: NCT05556733.

Keywords: Fecal Microbiota Transplantation; Gut Microbiome; Insomnia; Post-acute COVID-19 Syndrome.

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