Combined Gut-brain Therapy for Children With Autism

NCT04639141 | Completed

• 1 other identifier: ASD-MGB-RCT2020
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• GI symptom severity

  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.

  Baseline, 12 weeks, 24 weeks

Secondary Outcomes (3)

• ASD severity/behaviour

  Baseline, 12 weeks

• Anxiety

  Baseline, 12 weeks

• Gut microbiome

  Baseline, 12 weeks

Study Arms (2)

Synbiotic

ACTIVE COMPARATOR

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.

Combination Product: Synbiotic

Synbiotic + gut-directed hypnotherapy

EXPERIMENTAL

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; Behavioral: Gut-directed Hypnotherapy

Interventions

Synbiotic COMBINATION_PRODUCT

Prebiotic + Probiotic

Synbiotic; Synbiotic + gut-directed hypnotherapy

Gut-directed Hypnotherapy BEHAVIORAL

Psychotherapy sessions

Synbiotic + gut-directed hypnotherapy

Eligibility Criteria

• Age: 5 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Aged 5.00 years to 10.99 years
• 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.
• 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).

You may not qualify if:

• Non-verbal children and/or those with severe cognitive impairment
• Confirmed diagnosis of inflammatory bowel disease, coeliac disease, or current infection of the GI tract.
• \) 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

Sponsors & Collaborators

• The University of Queensland: lead

Study Sites (1)

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

Brisbane, Queensland, 4101, Australia

Location

MeSH Terms

Conditions

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

Interventions

Synbiotics

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Mental Disorders; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Prebiotics; Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Probiotics; Food and Beverages

Study Officials

• Leanne K Mitchell, B.HlthSc (Hons)

  The University of Queensland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 16, 2020
• First Posted: November 20, 2020
• Study Start: December 1, 2021
• Primary Completion: April 1, 2022
• Study Completion: June 30, 2022
• Last Updated: September 6, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)