ACTRN12621000029897Not yet recruiting未知
Effect of probiotic supplementation on composition of fecal microbiota in children with autism spectrum disorder-a pilot randomized controlled trial
Perth children hospital, Child and Adolescent health services0 sites40 target enrollmentStarted: January 14, 2021Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 40
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Treatment
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 2 Years to 5 Years (—)
- Sex
- All
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.
Investigators
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