Anxiety, Autism Spectrum Disorder, Functional Gastrointestinal Disorders, Neurodevelopmental Disorders
Conditions
Brief summary
CLINICAL ISSUE: Children with Autism Spectrum Disorder (ASD) are four times more likely to suffer with functional gastrointestinal disorders (FGIDs) than their neurotypical peers. The presence of FGIDs are linked to increased undesirable behaviour and ASD severity. Current behavioural approaches for ASD therapy do not alleviate the high comorbidity of FGIDs within this population. BACKGROUND: Dysfunction of the microbiome-gut-brain (MGB) axis has been implicated in pathogenesis of both ASD and FGIDs. Probiotics and prebiotics can modulate the gut microbiome and research has shown efficacy at improving gastrointestinal (GI) symptoms in children with ASD and neurotypical (NT) children with FGIDs. Gut-directed hypnotherapy (GDH) has shown utility in treating FGIDs in NT children and adults but has not yet been trialed in children with ASD. Targeting therapies to address the dysfunction of the bidirectional MGB axis will likely be more effective than either brain/behavioural or gut-based therapy alone. HYPOTHESIS: A synbiotic (prebiotic + probiotic mixture) with combined GDH will be more effective than a synbiotic alone at reducing GI symptoms in children with ASD aged 5.00 to 10.99 years over a 12-week period.
Interventions
COMBINATION_PRODUCTSynbiotic
Prebiotic + Probiotic
BEHAVIORALGut-directed Hypnotherapy
Psychotherapy sessions
Sponsors
The University of Queensland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants will be recruited and randomised (1:1) to one of two 12-week treatment intervention groups: 1) synbiotic or 2) synbiotic + gut-directed hypnotherapy. Follow-up will occur at week 24.
Eligibility
Sex/Gender
ALL
Age
5 Years to 10 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| GI symptom severity | Baseline, 12 weeks, 24 weeks | Change in GI symptom severity as measured by the 6-item gastrointestinal severity index (6-GSI). The 6-GSI assesses each GI symptom using a Likert scale of 0-2 (0 = nil/mild/infrequent; 1 = moderate/occasional; 2 = severe/frequent). Score range 0-12. Mild GI issues are defined as a score of under three and moderate or severe GI issues defined as a score of three or above. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ASD severity/behaviour | Baseline, 12 weeks | Change in ASD severity scores as measured by the Aberrant Behaviour Checklist (ABC) questionnaire. The ABC consists of five subscales, including: 1) irritability (15 items); 2) lethargy/social withdrawal(16 items); 3) Stereotypic Behaviour (7 items); 4) hyperactivity/noncompliance (16 items); and 5) Inappropriate Speech (4 items). Each item is scored as 0=never a problem, 1=slight problem, 2=moderately serious problem, or 3= severe problem. The score range is 0-174, with a higher score indicating greater severity or difficulties. |
| Anxiety | Baseline, 12 weeks | Change in anxiety levels as measured by the Parent Rated Anxiety Scale - Autism Spectrum Disorder (PRAS-ASD) questionnaire. This is a 25-item tool using a Likert scale of 0-3 (0=none; 1=mild; 2=moderate; 3=severe). Score range 0-75, with higher scores indicating greater levels of anxiety. |
| Gut microbiome | Baseline, 12 weeks | This is an explorative outcome to compare and characterise changes in gut (stool) microbiome composition and functional profiles using shotgun metagenomic sequencing. |
Countries
Australia
Outcome results
None listed