Trial to test whether drug that targets gut bacteria can improve irritability in teenagers with autism
A new trial will test whether a medication that targets gut bacteria can also improve irritability in teenagers with autism spectrum disorder.
The Tapestry study, a collaboration between the Murdoch Children’s Research Institute, Queensland Children’s Hospital, University of Sydney, Southern Adelaide Local Health Network and Flinders University is recruiting adolescents, aged 13-17, in Australia, the US and New Zealand with moderate to severe autism and who experience irritability such as aggression, self-harm and severe tantrums.
The trial medication, AB-2004, is designed to soak up certain toxins produced by bacteria in the gut to prevent them from entering the bloodstream and reaching the brain. Scientific studies have shown there may be a link between changes and irregularities in gut bacteria and the brain, which could contribute to certain neurological conditions, including irritability in children with autism. Gut bacteria are influenced by anxiety, poor diet and an unsettled sleep and stomach.
The medication is designed to act in the gut only and does not enter other bodily tissues, lessening the potential for side effects across other parts of the body. AB-2004 was shown to be safe and well tolerated in a previous study involving adolescents on the spectrum.
The trial, sponsored by Axial Therapeutics, across 25 hospital sites in Australia, the US and New Zealand, is seeking 140 participants. Axial is a pharmaceutical company dedicated to improving the lives of people with neurological conditions.
The 16-week trial includes taking the medication for eight weeks, six in-clinic visits and three telehealth appointments and the collection of blood, urine and stool samples as well as completing questionnaires.
The medication, a powder taken by mouth three times per day, is tasteless and odorless and is mixed with any soft food.
