Clinical trial NCT04639141: Combined Gut-brain Therapy for Children With Autism
Official title: The Utility of a Synbiotic With Adjunct Gut-directed Hypnotherapy on the Severity of Gastrointestinal Symptoms in Children With Autism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Functional Gastrointestinal Disorders
Neurodevelopmental Disorders
Anxiety
Lead sponsor: The University of Queensland
Sponsor class: OTHER
First posted: 2020-11-20
Enrollment: 40
Sex: ALL
Minimum age (years): 5
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: GI symptom severity
timeFrame: Baseline, 12 weeks, 24 weeks
Secondary outcomes:
measure: ASD severity/behaviour
timeFrame: Baseline, 12 weeks
measure: Anxiety
timeFrame: Baseline, 12 weeks
measure: Gut microbiome
timeFrame: Baseline, 12 weeks
Other outcomes:
Locations:
city: Brisbane
country: Australia
facility: University of Queensland, Child Health Research Centre, Faculty of Medicine
state: Queensland
Study officials:
affiliation: The University of Queensland
name: Leanne K Mitchell, B.HlthSc (Hons)
role: PRINCIPAL_INVESTIGATOR
References: