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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04639141




Registration number
NCT04639141
Ethics application status
Date submitted
16/11/2020
Date registered
20/11/2020
Date last updated
6/09/2023

Titles & IDs
Public title
Combined Gut-brain Therapy for Children With Autism
Scientific title
The Utility of a Synbiotic With Adjunct Gut-directed Hypnotherapy on the Severity of Gastrointestinal Symptoms in Children With Autism
Secondary ID [1] 0 0
ASD-MGB-RCT2020
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autism Spectrum Disorder 0 0
Functional Gastrointestinal Disorders 0 0
Neurodevelopmental Disorders 0 0
Anxiety 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Autistic spectrum disorders
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Combination Product - Synbiotic
Behaviour - 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.


Combination Product: Synbiotic
Prebiotic + Probiotic

Behaviour: Gut-directed Hypnotherapy
Psychotherapy sessions
Intervention code [1] 0 0
Combination Product
Intervention code [2] 0 0
Behaviour
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
GI symptom severity
Timepoint [1] 0 0
Baseline, 12 weeks, 24 weeks
Secondary outcome [1] 0 0
ASD severity/behaviour
Timepoint [1] 0 0
Baseline, 12 weeks
Secondary outcome [2] 0 0
Anxiety
Timepoint [2] 0 0
Baseline, 12 weeks
Secondary outcome [3] 0 0
Gut microbiome
Timepoint [3] 0 0
Baseline, 12 weeks

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).
Minimum age
5 Years
Maximum age
10 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/06/2022
Sample size
Target
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
University of Queensland, Child Health Research Centre, Faculty of Medicine - Brisbane
Recruitment postcode(s) [1] 0 0
4101 - Brisbane

Funding & Sponsors
Primary sponsor type
Other
Name
The University of Queensland
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04639141
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Leanne K Mitchell, B.HlthSc (Hons)
Address 0 0
The University of Queensland
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04639141