Combined gut-brain therapy for children with autism

Not Applicable

Active, not recruiting

• Conditions: Functional Gastrointestinal Disorders; Autism Spectrum Disorder; Anxiety; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon; Mental Health - Autistic spectrum disorders; Mental Health - Anxiety

• Registration Number: ACTRN12620001197921
• Lead Sponsor: niversity of Queensland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-10
• Last Update Posted: 14 March 2022

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

1.Aged 5.00 years to 10.99 years
2.A confirmed diagnosis of ASD or Pervasive Developmental Disorders (PDD) including autistic disorder, Asperger’s disorder (AS); PDD not otherwise specified (PDD-NOS); and atypical autism.
3.A diagnosis of a functional gastrointestinal disorder (FGID) by a gastroenterologist or a score of three and above on the six-item gastrointestinal severity index (6-GSI). Accepted FGIDs include diarrhoea, constipation, bloating, abdominal pain or irritable bowel syndrome (IBS).

Exclusion Criteria

1.Non-verbal children and/or those with severe cognitive impairment
2.Confirmed diagnosis of inflammatory bowel disease, coeliac disease, or current infection of the GI tract.
3) Any other medication, supplement or conditions which can impact the gut microbiome, including:
> antibiotics or antifungals in the last month
> probiotic or prebiotic supplements in the last two weeks
> immunocompromised or severely ill
> bipolar, schizophrenia, personality disorders
> diabetes mellitus or an eating disorder

Study & Design

• Study Type: Interventional
• Study Design: Not specified