FMT for Post-acute COVID-19 Syndrome

NCT05556733 | Unknown

• 1 other identifier: FMT-PACS
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

In recovered COVID-19 patients, emerging global data have reported the presence of long COVID, that is, at least one symptom that an alternative diagnosis cannot explain has been persistent for four or more weeks after the initial infection. We demonstrated previously that almost 80% of recovered COVID-19 patients in Hong Kong suffer from Long COVID for more than 6 months, affecting multiple body systems. In a recent study, the five most common Long COVID symptoms were fatigue, memory problem, difficulty sleeping, anxiety and hair loss. One promising hypothesis is the involvement of the gut microbiota, a collection of the trillions of gut microorganisms that play important immunomodulatory roles against infections. Faecal microbiota transplantation (FMT), which is the infusion of processed faeces from healthy donors to the gut of affected subjects, has shown impressive therapeutic effects for recurrent Clostridioides difficile infection and other emerging indications. Gut microorganisms together with the metabolites in the donated faeces could potentially modulate the gut microbiota of the recipient and treat the dysbiosis associated with pathological health conditions. To date, no study has yet to assess the therapeutic effects of FMT in post-COVID-19 neuropsychiatric conditions.

Conditions

Post-Acute COVID19 Syndrome; COVID-19

Keywords

Faecal Microbiota Transplantation

Outcome Measures

Primary Outcomes (1)

• Change in insomnia severity

  Severity of insomnia will be measured by a 7-item Insomnia Severity Index (ISI). ISI is a self-report questionnaire used to evaluate the nature, severity and impact of insomnia. Total score ranges from 0 to 28. Higher score indicates more severe insomnia.

  12 weeks

Secondary Outcomes (11)

• Change in sleep quality

  12 weeks

• Change in anxiety symptoms

  12 weeks

• Change in daytime sleepiness

  12 weeks

• Change in fatigue symptoms

  12 weeks

• Change in sleep diary parameters

  12 weeks

Study Arms (2)

Faecal Microbiota Transplantation

EXPERIMENTAL

Subjects will receive Faecal Microbiota Transplantation

Procedure: Faecal Microbiota Transplantation

Control

NO INTERVENTION

The control subjects will not receive FMT

Interventions

Faecal Microbiota Transplantation PROCEDURE

FMT at baseline, week 2, week 4, week 8

Faecal Microbiota Transplantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals aged 18 and above
• Subjects who were recovered cases of COVID-19 confirmed by RT-PCR or rapid antigen test (RAT)
• Subjects who had insomnia symptoms of post-acute COVID-19 syndrome at screening visit

You may not qualify if:

• Confirmed current active malignancy
• Had abdominal surgery
• Known history of severe organ failure (including decompensated cirrhosis), renal failure on dialysis, suffering from human immunodeficiency virus infection;
• Known pregnancy
• Mental retardation or inability to provide informed consent
• Contraindications to upper GI endoscopy

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong

Location

Related Publications (8)

• Sudre CH, Murray B, Varsavsky T, Graham MS, Penfold RS, Bowyer RC, Pujol JC, Klaser K, Antonelli M, Canas LS, Molteni E, Modat M, Jorge Cardoso M, May A, Ganesh S, Davies R, Nguyen LH, Drew DA, Astley CM, Joshi AD, Merino J, Tsereteli N, Fall T, Gomez MF, Duncan EL, Menni C, Williams FMK, Franks PW, Chan AT, Wolf J, Ourselin S, Spector T, Steves CJ. Attributes and predictors of long COVID. Nat Med. 2021 Apr;27(4):626-631. doi: 10.1038/s41591-021-01292-y. Epub 2021 Mar 10.

  PMID: 33692530 BACKGROUND

• Whitaker M, Elliott J, Chadeau-Hyam M, Riley S, Darzi A, Cooke G, Ward H, Elliott P. Persistent COVID-19 symptoms in a community study of 606,434 people in England. Nat Commun. 2022 Apr 12;13(1):1957. doi: 10.1038/s41467-022-29521-z.

  PMID: 35413949 BACKGROUND

• Tran VT, Porcher R, Pane I, Ravaud P. Course of post COVID-19 disease symptoms over time in the ComPaRe long COVID prospective e-cohort. Nat Commun. 2022 Apr 5;13(1):1812. doi: 10.1038/s41467-022-29513-z.

  PMID: 35383197 BACKGROUND

• Liu Q, Mak JWY, Su Q, Yeoh YK, Lui GC, Ng SSS, Zhang F, Li AYL, Lu W, Hui DS, Chan PK, Chan FKL, Ng SC. Gut microbiota dynamics in a prospective cohort of patients with post-acute COVID-19 syndrome. Gut. 2022 Mar;71(3):544-552. doi: 10.1136/gutjnl-2021-325989. Epub 2022 Jan 26.

  PMID: 35082169 BACKGROUND

• Li Y, Hao Y, Fan F, Zhang B. The Role of Microbiome in Insomnia, Circadian Disturbance and Depression. Front Psychiatry. 2018 Dec 5;9:669. doi: 10.3389/fpsyt.2018.00669. eCollection 2018.

  PMID: 30568608 BACKGROUND

• Allegretti JR, Mullish BH, Kelly C, Fischer M. The evolution of the use of faecal microbiota transplantation and emerging therapeutic indications. Lancet. 2019 Aug 3;394(10196):420-431. doi: 10.1016/S0140-6736(19)31266-8.

  PMID: 31379333 BACKGROUND

• Khoruts A, Sadowsky MJ. Understanding the mechanisms of faecal microbiota transplantation. Nat Rev Gastroenterol Hepatol. 2016 Sep;13(9):508-16. doi: 10.1038/nrgastro.2016.98. Epub 2016 Jun 22.

  PMID: 27329806 BACKGROUND

• Lau RI, Su Q, Ching JYL, Lui RN, Chan TT, Wong MTL, Lau LHS, Wing YK, Chan RNY, Kwok HYH, Ho AHY, Tse YK, Cheung CP, Li MKT, Siu WY, Liu C, Lu W, Wang Y, Chiu EOL, Cheong PK, Chan FKL, Ng SC. Fecal Microbiota Transplantation for Sleep Disturbance in Post-acute COVID-19 Syndrome. Clin Gastroenterol Hepatol. 2024 Dec;22(12):2487-2496.e6. doi: 10.1016/j.cgh.2024.06.004. Epub 2024 Jun 20.

  PMID: 38908733 DERIVED

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; COVID-19

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Siew Chien Ng, PhD, FRCP

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Siew Chien NG

Model Details: The intervention group will receive FMT while the control group will not receive FMT.

Study Record Dates

• First Submitted: August 18, 2022
• First Posted: September 27, 2022
• Study Start: September 28, 2022
• Primary Completion: September 13, 2023
• Study Completion: June 30, 2024
• Last Updated: October 31, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)