Research Centre: University of Queensland
Location: This is an Australian-wide virtual research study
Lead Researchers: Professor Peter Davies and Leanne K Mitchell, B.HlthSc (Hons)
HREC: This study has been reviewed and approved by the University of Queensland Human Research Ethics Committee
About the Study
Children with autism bring wonderful diversity to our lives. However, some can struggle with behavioural problems and anxiety. Many parents are aware that these challenges can impact their child’s ability to positively engage in school and community activities. These challenges can also have a significant effect at home and on the family unit.
Researchers believe that fostering a healthy gut environment may support people diagnosed with autism. This is a new yet promising approach that researchers from the University of Queensland want to explore. This research study investigates the gut-brain connection in autism. It will look into the effectiveness of combining probiotics with the prebiotics naturally found in breast milk as a supplement to lessen challenging behaviours in children diagnosed with autism. This study may also help reduce stomach and bowel issues that are often experienced by children with autism and improve the quality of life for children and their families.
- Participants will get a new potential therapeutic product that may promote a healthy gut at no cost.
- Participants may experience improvements to their behavioral challenges.
- Participants will be contributing valuable information that may benefit other children with autism in the future.
- Participants will be helping advance research supporting kids with autism.
- If you decide to participate your child in the study and later feel that you no longer wish your child to be part of it, you can withdraw your child from this study at any time.
- Any information that you provide about you or your child will be kept strictly confidential, except as required by law.
- Qualified health professionals will monitor your child’s health as it relates to the study.
Who Can Participate?
- Children aged 5-12 years old who are diagnosed with Autism Spectrum Disorder (ASD) by a licensed physician
- This study involves parental and/or legal guardian consent and participation
- Must not have any organic gastrointestinal (stomach and gut) disorders such as inflammatory bowel disease, coeliac disease, eosinophilic disorders or current infection of the gastrointestinal tract.
- Must not have had bowel surgery or suffer from short bowel syndrome
- Must not have diabetes, an eating disorder, a genetic disorder/condition or be immunocompromised or severely ill.
- Must be able to attend 3 virtual study appointments for over approximately 8 weeks with a total enrollment of approximately 16 weeks.
Key Study Details
The study team can explain the research study in its entirety but some study details are:
- Depending on the participant’s location, the research team may ask the participant along with their parent or legal guardian to come to the research centre for an in-person study visit. The study team can further explain this.
- The study product is a supplement. Previous research has shown that the components found in the supplement (prebiotics found in breast milk and probiotics) have the ability to alter gut bacteria, restore gut barrier integrity, and reduce inflammation.
- The study involves 2 phases of 8 weeks each. In the first phase, children will be allocated to either the treatment (study product) or control (placebo) group. All participants will then go into the second phase, in which both groups will receive the study product.
- Participation in this study involves submitting stool, urine and saliva samples. Some of these samples will need to be delivered to a local collection centre.
- Parents/guardians will need to deliver some of the samples to a collection centre. This means they will need to be located within a reasonable distance to the collection centre. There are no collection centres in Tasmania and only one in Queensland (QLD). The collection centre in Queensland is located centrally in Brisbane city.
About the Research Centre:
University of Queensland
The University of Queensland is one of Australia’s top research-intensive universities. The University of Queensland (UQ) is consistently awarded the maximum five-star rating for research grants and research intensity in the Good Universities Guide, with the University’s reputation for research excellence underpinned by its 55th global ranking in the Academic Ranking of World Universities, the most influential global university ranking.
Due to the current situation with the COVID-19 pandemic, the study team would like to point out that this study can be conducted remotely, which means there will be no in-person study visits, allowing parents and their children to participate in the comfort of their own home and having no close interactions with any person outside of their household.