Effect of Probiotic supplementation on gut bacteria in children with autism - a pilot randomized controlled trial

Not Applicable

• Conditions: Autism spectrum disorder; Mental Health - Autistic spectrum disorders

• Registration Number: ACTRN12621000029897
• Lead Sponsor: Perth children hospital, Child and Adolescent health services

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-14
• Last Update Posted: 12 April 2021

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

(1)Children Age: 2–5 years. (2) Confirmed diagnosis of ASD based on DSM-5 criteria.

Exclusion Criteria

(1) Major congenital anomalies (2) Epilepsy syndromes, significant sensory impairment (e.g., blindness, deafness), neonatal hypoxic ischemic encephalopathy requiring therapeutic cooling (3) Coeliac disease, inflammatory bowel disease (4) Use of probiotics for 4 weeks in the 90 days before enrolment (5) Current or recent (within 4 weeks before enrolment) exposure to antibiotics, chemotherapy or immunosuppressant agents, or laxatives. (6) Prosthetic devices including heart valves (7) Confirmed HIV, Hepatitis B, and/or Hepatitis C. (8) Known allergy to probiotics (9) Special diets(10) Cows’ milk protein allergy, food allergy, or conditions such as atopic dermatitis, or eczema.

Study & Design

• Study Type: Interventional
• Study Design: Not specified