Researchers at Deakin University’s Food and Mood Centre have begun a clinical trial to explore whether targeting the gut microbiome may be a safe and feasible potential treatment approach for people living with Long COVID.
The GLOW Trial is investigating whether faecal microbiota transplant (FMT) – the transfer of carefully screened donor gut bacteria – can be delivered safely and acceptably to adults with Long COVID.
Food and Mood Centre’s Dr Amelia McGuinness said emerging research suggests that COVID-19 can affect the gut during infection, and some studies have found differences in gut bacteria and markers of inflammation in people with Long COVID compared to those who have recovered.
‘The gut microbiome plays an important role in immune function and communication between the gut and the brain,’ Dr McGuinness said.
‘If COVID-19 affects the gut in some individuals, then targeting the gut microbiome may represent a new way to help improve symptoms in people with Long COVID. Even small improvements could make a meaningful difference to people’s ability to carry out everyday activities and reconnect with work, study, family and social life.’
Dr McGuinness said Long COVID was a growing public health challenge and could significantly disrupt people’s ability to work, study, spend time with family and friends, and carry out everyday activities.
‘Some people experience many symptoms, while others experience only a few—but even a small number can have a major impact on daily life. For some people the condition can be severe enough to prevent them from working or leaving the house,’ she said.
‘People with Long COVID often experience worsening of symptoms after physical or mental exertion, meaning even small activities can trigger a significant setback.
‘Other commonly reported symptoms include severe fatigue that persists despite rest or sleep, cognitive difficulties (“brain fog”), sleep disturbance, as well as neurological, respiratory, cardiac, pain and gut problems. Despite the scale and impact of the condition, there are currently limited evidence-based treatment options.
‘It is important to note that this research is an early-phase feasibility trial. It is not designed to determine whether FMT is an effective treatment, but rather to first assess safety, tolerability, and whether a larger, definitive trial would be warranted.’
FMT is an established treatment for recurrent Clostridioides difficile infection under strict regulatory oversight in Australia. Its use in Long COVID remains experimental and requires careful evaluation in controlled clinical trials.
The GLOW trial will enrol 40 adults aged 18 years and over who have been diagnosed with Long COVID and experience moderate to severe difficulty with daily activities.
Participants will be randomly allocated to receive either donor FMT or a placebo treatment that will be administered via rectal enema. Over the eight-week study, participants will complete questionnaires and assessments at home, attend in-person visits, provide blood, urine, and stool samples, and wear a Garmin device. Participants will be followed up at 3, 6 and 12 months.
Dr McGuinness and the research team worked closely with people with lived experience of Long COVID through a series of co-design workshops held over several months. Participants provided detailed feedback on study materials, participant resources and recruitment strategies to help ensure the trial is appropriate and manageable for people living with the condition.
The GLOW trial is being conducted through Barwon Health’s Adrian Costa Clinical Trials Centre (ACCTC) as part of the Barwon Health Deakin University Clinical Trials Alliance. It is supported by partnerships with Emerge Australia/AusME Registry, to help connect with the Long COVID community, and Australian Red Cross Lifeblood, which is manufacturing the FMT product under Therapeutic Goods Administration (TGA) standards. The trial is funded by the Australian Government through the Medical Research Future Fund (MRFF).
‘People living with Long COVID can experience significant disruption to their health and daily life, and with few treatment options available, there is a strong need to carefully test new approaches in a rigorous and responsible way,’ Dr McGuinness said.
‘If this approach proves to be safe and acceptable, it will lay the groundwork for larger trials to determine whether microbiome-based therapies such as FMT can improve outcomes for people living with Long COVID.’
To find out more about the GLOW trial and how to be involved, visit: https://foodandmoodcentre.com.au/projects/gut-therapy-to-improve-long-covid-outcomes-and-wellbeing-the-glow-trial/
The FMT provided for the trial by Australian Red Cross Lifeblood will come from generous, non-remunerated stool donors in Perth, and will be manufactured into FMT after careful testing and processing.
To become a donor or learn more, visit lifeblood.com.au/microbiome or call 1300 441 227
This media release was originally created and published by Deakin Media and is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).
Share