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Trial registered on ANZCTR


Registration number
ACTRN12620001197921
Ethics application status
Approved
Date submitted
15/09/2020
Date registered
10/11/2020
Date last updated
9/03/2022
Date data sharing statement initially provided
10/11/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Combined gut-brain therapy for children with autism
Scientific title
The utility of a synbiotic and adjunct gut-directed hypnotherapy on severity of gastrointestinal symptoms in children with autism spectrum disorder: a randomised controlled trial
Secondary ID [1] 302310 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Functional Gastrointestinal Disorders 319069 0
Autism Spectrum Disorder 319070 0
Anxiety
 319071 0
Condition category
Condition code
Oral and Gastrointestinal 317021 317021 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Mental Health 317022 317022 0 0
Autistic spectrum disorders
Mental Health 317023 317023 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
1) Synbiotic
Mode of administration: oral. The product is a tasteless & odourless powder that dissolves in liquid or semi-solid food.
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).
Compliance: parents/guardian of participants will be provided with a "Participant Monitoring Sheet" to note dosing compliance which will be follow-up fortnightly by the Principal Investigator by phone/email.
2) Gut-directed hypnotherapy
Mode of administration: home-based therapy program (recordings). Therapy will be developed/delivered by the Principal Investigator who is a qualified clinical hypnotherapist. Recordings will be delivered to parent/guardians of participants by email.
Overview: a total of six (6) recordings will be issued, each representing a discrete therapy session. Sessions are based on the Manchester model of 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 therapy program. 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. Duration will vary between 15-20min.
Compliance: parents/guardian of participants will be provided with a "Participant Monitoring Sheet" to note home-based recording use. This will be follow-up fortnightly by the Principal Investigator by phone/email.
Intervention code [1] 318600 0
Treatment: Other
Intervention code [2] 318601 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 325128 0
Change in GI symptom severity as measured by the 6-item gastrointestinal severity index (6-GSI).
Timepoint [1] 325128 0
Baseline, 12 weeks (primary timepoint) and 24 weeks post intervention
Secondary outcome [1] 386944 0
Change in ASD severity scores as measured by the Autism Treatment Evaluation Checklist (ATEC) questionnaire
Timepoint [1] 386944 0
Baseline and post-intervention (12 weeks)
Secondary outcome [2] 386945 0
Change in anxiety levels as measured by the Parent Rated Anxiety Scale - Autism Spectrum Disorder (PRAS-ASD) questionnaire.
Timepoint [2] 386945 0
Baseline and post-intervention (12 weeks)
Secondary outcome [3] 386946 0
Compare and characterise the gut (stool) microbiome composition and functional profiles using shotgun metagenomic sequencing. Shotgun metagenomic sequencing is able to report relative abundance of bacterial species and their genetic functional potentials - this is a composite outcome.
Timepoint [3] 386946 0
Baseline and post intervention (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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple, block randomisation generated by computerised sequence
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Power calculations are based on previous data and allow for drop-outs and missing data. Results will be considered statistically significant with P values less than or equal to 0.05. Statistical analysis will be performed using the Statistical Package for Social Sciences (SPSS) program.

Potential differences in longitudinal changes in primary and secondary outcome variables will be assessed using repeated measures ANOVA at 12 weeks and 24 weeks post baseline. Associations between variables may be assessed using correlation analysis.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
23/11/2020
Actual
6/12/2020
Date of last participant enrolment
Anticipated
30/11/2021
Actual
30/11/2021
Date of last data collection
Anticipated
17/05/2022
Actual
Sample size
Target
40
Accrual to date
Final
36
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 306737 0
Commercial sector/Industry
Name [1] 306737 0
DSM Nutritional Products AG
Country [1] 306737 0
Switzerland
Primary sponsor type
University
Name
University of Queensland
Address
62 Graham Street
South Brisbane
Queensland 4101
Country
Australia
Secondary sponsor category [1] 307286 0
None
Name [1] 307286 0
Address [1] 307286 0
Country [1] 307286 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306908 0
Children's Health Queensland Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 306908 0
Ethics committee country [1] 306908 0
Australia
Date submitted for ethics approval [1] 306908 0
24/04/2020
Approval date [1] 306908 0
27/05/2020
Ethics approval number [1] 306908 0
HREC/20/QCHQ/58792
Ethics committee name [2] 306911 0
University of Queensland Human Research Ethics Committee
Ethics committee address [2] 306911 0
Ethics committee country [2] 306911 0
Australia
Date submitted for ethics approval [2] 306911 0
27/05/2020
Approval date [2] 306911 0
29/05/2020
Ethics approval number [2] 306911 0
2020001211

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 105410 0
Prof Peter Davies
Address 105410 0
Child Health Research Centre, Faculty of Medicine
University of Queensland
62 Graham Street
South Brisbane QLD 4101
Country 105410 0
Australia
Phone 105410 0
+61 7 3069 7597
Fax 105410 0
Email 105410 0
ps.davies@uq.edu.au
Contact person for public queries
Name 105411 0
Leanne Mitchell (PhD Candidate)
Address 105411 0
Child Health Research Centre, Faculty of Medicine
University of Queensland
62 Graham Street
South Brisbane QLD 4101
Country 105411 0
Australia
Phone 105411 0
+61 4146 89850
Fax 105411 0
Email 105411 0
leanne.mitchell@uq.edu.au
Contact person for scientific queries
Name 105412 0
Leanne Mitchell (PhD Candidate)
Address 105412 0
Child Health Research Centre, Faculty of Medicine
University of Queensland
62 Graham Street
South Brisbane QLD 4101
Country 105412 0
Australia
Phone 105412 0
+61 4146 89850
Fax 105412 0
Email 105412 0
leanne.mitchell@uq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
IPD is the intellectual property of the funding industry partner.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.