The impact of faecal microbiome transfer on gut health in autistic adolescents and young adults

Not Applicable

Recruiting

• Conditions: Autism; Functional gastrointestinal disorders; Mental Health - Autistic spectrum disorders; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12622000015741
• Lead Sponsor: niversity of Auckland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-01-11
• Last Update Posted: 13 March 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Aged 16-30 years inclusive at time of enrolment recruitment
Previous formal diagnosis of autism (including ASD, Asperger's Syndrome, Autistic Disorder, and PDD-NOS) as characterised in DSM-4, DSM-5, or ICD-10-AM
Moderate to severe gastrointestinal symptoms with mean overall GSRS score =2.0
Believe they are able to swallow treatment capsules
Willing to comply with the clinical assessments at baseline and follow-up visits

Exclusion Criteria

Systemic antibiotic use within the preceding month
Intake of probiotic supplements within the preceding month
Regular steroid treatment
Dependence upon tube feeding
Serious medical problems that require specific treatment
Moderate to severe depression and/or suicidal ideation as per PHQ-9
Pregnancy
Known allergy to any medications or foods and/or to macrogol

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Gastrointestinal symptoms using the Gastrointestinal Symptoms Rating Scale (GSRS) overall score[6 weeks post-intervention]