None listed
Conditions
Brief summary
Autism is a condition with early-onset difficulties in social communication and unusually restricted, repetitive behaviors. It is being increasingly diagnosed in the last 10 years and is currently diagnosed in 1 in 59 children. Children with Autism need lifelong support for their symptoms and associated conditions. Current options for improving their behavioral issues are limited or only partially effective. Beneficial bacteria that commonly live in the gut promote health by suppressing the growth of harmful bacteria, and improving immune function of the gut. Humans have been consuming probiotics (beneficial bacteria) for hundreds of years in the form of various foods. . Research suggests that the proportion of beneficial bacteria in the gut is reduced (called as ‘dysbiosis’) in children with autism, and may explain their symptoms. We plan to study whether probiotic supplementation will improve the proportion of beneficial bacteria in the gut of children with autism. Such an effect may improve their behavioral symptoms
Interventions
The participants will receive 450 billion CFU of probiotics (or an equivalent volume of placebo) twice a day for one month followed by 450 billion CFU (or an equivalent volume of placebo) once a day for three months.The probiotic selected for this study is Vivomixx® Italy, with each sachet containing total 450 billion (450x10^9) lyophilized bacterial cells of eight probiotic strains: Streptococcus thermophilus DSM 24731, B. breve DSM 24732, B. longum DSM 24736, B. infantis DSM 24737), and L. aci
The participants will receive 450 billion CFU of probiotics (or an equivalent volume of placebo) twice a day for one month followed by 450 billion CFU (or an equivalent volume of placebo) once a day for three months.The probiotic selected for this study is Vivomixx® Italy, with each sachet containing total 450 billion (450x10^9) lyophilized bacterial cells of eight probiotic strains: Streptococcus thermophilus DSM 24731, B. breve DSM 24732, B. longum DSM 24736, B. infantis DSM 24737), and L. acidophilus DSM 24735, L. plantarum DSM 24730, L. paracasei DSM 24733, L. delbrueckii subsp. bulgaricus DSM 24734). All strains in Vivomixx work in synergy (http://www.vivomixx.eu/en/2017/09/06/product-facts-why-so-many-different-strains/) Vivomixx® is currently being studied for various conditions in children (non-alcoholic steatohepatitis, infantile colic and ASD) and adults (HIV) , and pregnant women. It is available as water-soluble powder and administered orally. It can be dissolved directly in the mouth or mixed in a cold, but not carbonated drink. During the study period to monitor adherence, we will check if there have been any changes in diet or medications. This will involve 2 phone calls a month apart. Any left over probiotics sachets with the parents will be asked to bring during there last visit to be returned to pharmacy.
Sponsors
Perth children hospital, Child and Adolescent health services
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
2 Years to 5 Years
Healthy volunteers
No
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.
Outcome results
None listed