Autism
Conditions
Keywords
autism, preschool children
Brief summary
Autism Spectrum Disorders (ASD) comprises a complex group of disorders of neuronal development characterized by social and communication impairment along with presence of repetitive and restrictive behaviors. Emerging evidences support the gut-brain axis and further microbiota-gut-brain axis. Elevated prevalence of gastrointestinal (GI) dysfunction in individuals with ASD suggested that targeting gut may benefit patients with ASD. Lactobacillus plantarum PS128 (PS128) was reported to be a psychobiotic in several animal studies which modulated the levels of neurotransmitters in different brain areas. The current randomized, placebo-controlled trial was conducted to investigate the psychophysiological effects of PS128 in preschool children with ASD.
Detailed description
Emerging evidences support the gut-brain axis and further microbiota-gut-brain axis. Elevated prevalence of gastrointestinal (GI) dysfunction in individuals with ASD suggested that targeting gut may benefit patients with ASD. Lactobacillus plantarum PS128 (PS128) was reported to be a psychobiotic in several animal studies which modulated the levels of neurotransmitters in different brain areas. The current randomized, placebo-controlled trial was conducted to investigate the psychophysiological effects of PS128 in preschool children with ASD.
Interventions
OTHERProbiotic, Lactobacillus plantarum PS128
PS128 capsules, 2 capsules per day
OTHERPlacebo, microcrystalline cellulose
Placebo capsules, 2 capsules per day
Sponsors
Mackay Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Investigators, researchers, outcome assessors, subjects and caregivers will be blinded to the randomization. A research assistant who is not involved in this trial will do the randomization by using randomly permuted blocks within the strata of two assignments, the placebo group and PS128 group with the ratio of 1:1.
Intervention model description
Double-blinded, randomized, placebo-controlled
Eligibility
Sex/Gender
ALL
Age
30 Months to 7 Years
Healthy volunteers
Yes
Inclusion criteria
* Fulfill Diagnostic and Statistical Manual of Mental Disorders fifth version (DSM-V) criteria of Autism Spectrum Disorder * Do not take any other probiotics for at least 3 weeks before and during the study period
Exclusion criteria
* Autistic children with other neurodevelopmental disorders or psychiatric diseases * With a clinically significant chronic medical condition, including; anemia, brain malformations, metabolic diseases, epilepsy, organic gastrointestinal disorders (i.e. gastroesophageal reflux, food allergies, irritable bowel syndrome (IBS)) and Celiac disease * On anti-fungal, antibiotics, special diet (i.e. gluten-free diet, casein-free diet, high-protein diet, ketogenic diet) and current use of psychiatric medications within the preceding 3 weeks were excluded * Known allergy to probiotics
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes from baseline of anxiety subscale in Children's Behavior Checklist (CBCL)/Achenbach System of Empirically Based Assessment (ASEBA) at week 8 and week 16 | Baseline, week 8 and week 16 | ASEBA for behavioral assessment |
| Changes from hyperactivity subscale of Attention-Deficit/Hyperactivity Disorder Test (ADHDT) at week 8 and week 16 | Baseline, week 8 and week 16 | Inattention, hyperactive symptoms evaluation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of total scores at week 8 and week 16 from baseline of Penn Interactive Peer Play Scale, (PIPPS) | Baseline, week 8 and week 16 | PIPPS for communicative and interactive assessment |
| Gastrointestinal symptoms recorded by using GI Severity Index (6-GSI) at week 8 and week 16 | Baseline, week 8 and week 16 | constipation, diarrhea, stool consistency, stool smell, flatulence, and abdominal pain |
| Comparison of Microbiota composition between week 8 and baseline | Baseline and week 8 | Gut and oral microbiota analysis |
| Change of total scores at week 8 and week 16 from baseline of Social Interaction Assessment Scale | Baseline, week 8 and week 16 | Communicative and interactive assessment |
| Change of total scores at week 8 and week 16 from baseline of Changes of Childhood Asperger Syndrome Test (CAST) | Baseline, week 8 and week 16 | CAST for behavioral assessment |
Countries
Taiwan
Contacts
Primary ContactHui-Ju Chen MD
Backup ContactHui-Ju Chen MD
Outcome results
None listed