Trials / Completed
CompletedNCT04639141
Combined Gut-brain Therapy for Children With Autism
The Utility of a Synbiotic With Adjunct Gut-directed Hypnotherapy on the Severity of Gastrointestinal Symptoms in Children With Autism
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- The University of Queensland · Academic / Other
- Sex
- All
- Age
- 5 Years – 10 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| COMBINATION_PRODUCT | Synbiotic | Prebiotic + Probiotic |
| BEHAVIORAL | Gut-directed Hypnotherapy | Psychotherapy sessions |
Timeline
- Start date
- 2021-12-01
- Primary completion
- 2022-04-01
- Completion
- 2022-06-30
- First posted
- 2020-11-20
- Last updated
- 2023-09-06
Locations
1 site across 1 country: Australia
Source: ClinicalTrials.gov record NCT04639141. Inclusion in this directory is not an endorsement.