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Completed

NCT Number: NCT04639141

Combined Gut-brain Therapy for Children With Autism

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.

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Key information

Conditions

Autism Spectrum Disorder Anxiety Anxiety Disorders Child Development Disorders, Pervasive Digestive System Diseases Functional Gastrointestinal Disorders Gastrointestinal Diseases Mental Disorders Neurodevelopmental Disorders

Age range

5 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Queensland, Child Health Research Centre, Faculty of Medicine

Brisbane, Queensland, 4101, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 5.00 years to 10.99 years
  • 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.
  • 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

  • Non-verbal children and/or those with severe cognitive impairment
  • Confirmed diagnosis of inflammatory bowel disease, coeliac disease, or current infection of the GI tract.
  • 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

Treatment and study plan

Synbiotic

Combination Product

Prebiotic + Probiotic

Gut-directed hypnotherapy

Behavioral

Psychotherapy sessions

Primary outcomes

  1. GI symptom severity

    Time frame: 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 outcomes

  1. ASD severity/behaviour

    Time frame: 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.

  2. Anxiety

    Time frame: 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.

  3. Gut microbiome

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

The University of Queensland

Other

Registry information

Official study title

The Utility of a Synbiotic With Adjunct Gut-directed Hypnotherapy on the Severity of Gastrointestinal Symptoms in Children With Autism

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 20, 2020
Registry last updated
Sep 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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