None listed
Conditions
Brief summary
The overall research aim is to reduce the burden of functional gastrointestinal disorders (FGIDs) in children with Autism Spectrum Disorder (ASD) with possible amelioration of ASD-associated behaviours and anxiety disorders. Children diagnosed with ASD and comorbid FGIDs aged 5.00-10.99 years (n=40) will be recruited through community and clinical settings and randomised (1:1) to one of two 12-week treatment groups: 1) synbiotic or 2) synbiotic + gut-directed hypnotherapy. The primary outcome will be changes in GI symptom severity as measured by the 6-item gastrointestinal severity index (6-GSI). Secondary measures include changes to ASD severity (ATEC questionnaire) and anxiety scores (PRAS-ASD questionnaire) and biological measures to characterise the gut microbiome (metagenomic DNA sequencing) among participants. It is hypothesised that a combined treatment approach (synbiotic + GDH) will be more effective than a synbiotic alone at reducing GI symptoms in the target population.
Interventions
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), Bifidobac
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.
Sponsors
University of Queensland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
5 Years to 10 Years
Healthy volunteers
No
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
Outcome results
None listed