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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04639141
Registration number
NCT04639141
Ethics application status
Date submitted
16/11/2020
Date registered
20/11/2020
Titles & IDs
Public title
Combined Gut-brain Therapy for Children With Autism
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Scientific title
The Utility of a Synbiotic With Adjunct Gut-directed Hypnotherapy on the Severity of Gastrointestinal Symptoms in Children With Autism
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Secondary ID [1]
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ASD-MGB-RCT2020
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Autism Spectrum Disorder
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Functional Gastrointestinal Disorders
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Neurodevelopmental Disorders
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Anxiety
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Condition category
Condition code
Mental Health
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Autistic spectrum disorders
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Neurological
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Synbiotic
BEHAVIORAL - Gut-directed Hypnotherapy
Active comparator: Synbiotic - Dosing: one sachet/dose per day for 12 weeks. The combination includes: Lactobacillus rhamnosus (1x10\^10 CFU/dose), Lactobacillus plantarum (4 x 10\^9 CFU/dose), Bifidobacterium animalis subsp. lactis (5 x 10\^9 CFU/dose), Bifidobacterium longum (1 x 10\^9 CFU/dose) + 4g/dose of partially hydrolysed guar gum (PHGG).
Mode of administration: oral.
Experimental: Synbiotic + gut-directed hypnotherapy - Includes the daily oral synbiotic (as pervious described) + a home-based therapy program.
Home-based therapy program: based on the Manchester model of gut-directed hypnotherapy (GDH) adapted for use in children with ASD. The GDH core therapy focus areas will be relaxation, control of gut function and ego-strengthening.
Schedule: daily use of a home-based audio recordings. The program will consist of six (6) therapy sessions/recordings over 12 weeks. Each recording (sessions 1 through 6) is to be used daily for a fortnight. Each session is approximately 15-20 minutes in duration.
Other interventions: Synbiotic
Prebiotic + Probiotic
BEHAVIORAL: Gut-directed Hypnotherapy
Psychotherapy sessions
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Intervention code [1]
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Other interventions
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Intervention code [2]
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BEHAVIORAL
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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GI symptom severity
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline, 12 weeks, 24 weeks
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Secondary outcome [1]
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ASD severity/behaviour
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline, 12 weeks
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Secondary outcome [2]
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Anxiety
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Assessment method [2]
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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.
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Timepoint [2]
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Baseline, 12 weeks
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Secondary outcome [3]
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Gut microbiome
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Assessment method [3]
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This is an explorative outcome to compare and characterise changes in gut (stool) microbiome composition and functional profiles using shotgun metagenomic sequencing.
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Timepoint [3]
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Baseline, 12 weeks
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Eligibility
Key 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).
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Minimum age
5
Years
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Maximum age
10
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/12/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
30/06/2022
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Sample size
Target
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Accrual to date
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Final
40
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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University of Queensland, Child Health Research Centre, Faculty of Medicine - Brisbane
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Recruitment postcode(s) [1]
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4101 - Brisbane
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Funding & Sponsors
Primary sponsor type
Other
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Name
The University of Queensland
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT04639141
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Leanne K Mitchell, B.HlthSc (Hons)
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Address
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The University of Queensland
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
IPD is the intellectual property of the funding industry partner.
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04639141