None listed
Conditions
Brief summary
The GLOW Trial is a randomised, double-blind, placebo-controlled feasibility trial of enema-delivered faecal microbiome transplant for Long COVID. This trial aims to test the feasibility of a clinical trial protocol of enema-delivered faecal microbiome transplantation (FMT) in adults living with Long COVID.
Interventions
Human faecal microbiome transplantation enemas, comprising donor faeces (16.7g), saline, and glycerol, rectally delivered via 3 x 50mL enemas.
Enemas will be administered one per day on consecutive days. Research nurses will administer the enemas in a clinical setting.
Sponsors
Deakin University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
• Aged 18-65 years. • Documented diagnosis of Long COVID confirmed by a specialist at a dedicated Long COVID clinic or a healthcare provider with recognised expertise in managing post-COVID conditions, with verifiable documentation. • Experiencing moderate to severe functional impairment due to their Long COVID, measured as a World Health Organisation Disability Assessment Scale (WHODAS 2.0 12-item) score of equal to or greater than 50. • Willing and able to wear a Garmin wrist health tracking device for the duration of the study, without known allergies to materials used in the device (e.g., nickel, silicone). • Willing and able to give informed consent prior to study enrolment and to comply with study procedures, including attending the study site for in-person study appointments. • Able to commit to the ongoing use of hormonal (e.g., oral contraceptive pill, intrauterine device) or non-hormonal (e.g., barrier methods) contraception if sexually active and of childbearing potential age during the trial period. • Has access to a device capable of downloading and using the WeGuide application, with stable internet access using a smartphone, laptop, or desktop computer.
Exclusion criteria
• History of major gastrointestinal conditions, including but not limited to: o suspected bowel perforation at time of intervention delivery. o Coeliac’s disease (due to potential risk of gluten contamination in the FMT). o severe, active inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis) including recent flares and/or complications (e.g., abscess, fistulae, severe bleeding). o any other major gastrointestinal conditions considered to increase the risk of complications, compromise participant safety, or confound study outcomes, as determined by the Investigator or their delegate. • History of major gastrointestinal surgery, including but not limited to: o resection of large portions of the intestines (e.g., total colectomy, hemicolectomy) o presence of colostomy or ileostomy o any other major gastrointestinal surgeries considered to increase the risk of complications, compromise participant safety, or confound study outcomes, as determined by the Investigator or their delegate. • Known immunosuppression or immunodeficiency, including, but not limited to: o uncontrolled HIV (e.g., CD4 count < 240 cells/mm3). o history of bone marrow transplant. o severe hepatic impairment (e.g., decompensated cirrhosis). o use of major immunosuppressive agents, including high-dose corticosteroids (e.g., prednisolone equal to or greater than 60mg/day, calcineurin inhibitors, mTOR inhibitors, lymphocyte-depleting biologic agents, anti-TNF therapy, or chemotherapy). o any other immunosuppression or immunodeficiencies considered to increase the risk of complications, compromise participant safety, or confound study outcomes, as determined by the Investigator or their delegate. • Conditions that prevent safe or comfortable administration of an enema including, but not limited to: o severe haemorrhoids prone to bleeding or causing significant pain during rectal procedures. o history of rectal fissures or chronic anal ulcers that could be aggravated by enema insertion. o rectal prolapse or anal stenosis that may obstruct safe insertion of the enema syringe. o recent rectal or anal surgery within the past 6 months, such as for fistula repair or haemorrhoidectomy. o diagnosed conditions that cause involuntary muscle spasms or severe pain in the rectal area (e.g., anismus, proctalgia fugax). o active perianal infections such as abscesses or other rectal infections. o history of severe bowel obstruction or chronic constipation that may interfere with enema administration. o congenital abnormalities of the rectum or anus that obstruct enema insertion. o significant psychological distress or trauma associated with rectal procedures, making the enema procedure intolerable. o any other condition considered a contraindication to enema delivery, as determined by the Investigator or their delegate. • Received FMT (e.g., oral, endoscope, rectal) within the past 12 months prior to consent. • Use of bowel preparation within the past 6 months prior to consent (delayed commencement allowed). • Use of any other rectally delivered enema within the past 3 months prior to consent (e.g. fleet enema) (delayed commencement allowed). • History of anaphylactic or anaphylactoid reactions, particularly to components that may be present in the FMT preparation. • Currently pregnant or breastfeeding, or planning pregnancy, egg donation, or egg retrieval within the 8-week study period. • Males planning to conceive a child or donate sperm during the study or within 90 days after last dose of Investigational Product. • Participating in another intervention trial that may interfere with study outcomes. • Known or suspected active and unstable medical disorder that may compromise participant safety, as determined by the Investigator or their delegate. • Commencement, dosage change, or discontinuation of medication for a stable ongoing condition (e.g., antidepressants) within the 30 days prior to consent (delayed commencement allowed). • Use of antibiotics within the 90 days prior to consent (delayed commencement allowed). • Commencement or discontinuation of probiotics, synbiotics, prebiotics, or other supplements intended to impact gut health or the gut microbiome within the 30 days prior to consent (delayed commencement allowed). • Commencement, dosage change, or discontinuation of COVID-19 specific treatment drugs (e.g., antiviral medications such as Paxlovid, monoclonal antibodies like sotrovimab) within the 30 days prior to consent (delayed commencement allowed). • Receipt of a COVID-19 vaccine within the 28 days prior to consent or any other vaccination (e.g., influenza, pneumococcal) within the 14 days prior to consent. • Participants who are mentally or legally incapacitated and unable to provide informed consent, or whose condition may interfere with compliance to the trial protocol, as judged by the Investigator or their delegate. • Known allergy/intolerance to excipients present in the intervention and placebo enemas, including any of the following: Normal saline (0.9% NaCl), Glycerol (Glycerolyte 57), Food colourants (specifically Brown HT (CI 20285 / E155) and Brilliant Blue FCF (CI 42090 / E133)), Preservative 211 (Sodium Benzoate), Food acid 330 (citric Acid)
Outcome results
None listed