Combined Gut-brain Therapy for Children With Autism

NCT ID: NCT04639141

Last Updated: 2023-09-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2022-06-30

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.

Conditions

Autism Spectrum Disorder; Functional Gastrointestinal Disorders; Neurodevelopmental Disorders; Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Synbiotic

Intervention Type: COMBINATION_PRODUCT

Prebiotic + Probiotic

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.

Group Type: EXPERIMENTAL

Synbiotic

Intervention Type: COMBINATION_PRODUCT

Prebiotic + Probiotic

Gut-directed Hypnotherapy

Intervention Type: BEHAVIORAL

Psychotherapy sessions

Interventions

Synbiotic

Prebiotic + Probiotic

Intervention Type: COMBINATION_PRODUCT

Gut-directed Hypnotherapy

Psychotherapy sessions

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Queensland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Leanne K Mitchell, B.HlthSc (Hons)

Role: PRINCIPAL_INVESTIGATOR

The University of Queensland

Locations

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

Brisbane, Queensland, Australia

Countries

Australia

Other Identifiers

ASD-MGB-RCT2020

Identifier Type: -

Identifier Source: org_study_id