Psychophysiological Effects of Lactobacillus Plantarum PS128 in Preschool Children With Autism Spectrum Disorder

Mackay Memorial Hospital

Status: Unknown

Conditions: Autism

Treatments: Other: Placebo, microcrystalline cellulose; Other: Probiotic, Lactobacillus plantarum PS128

Study type: Interventional

Funder types: Other

Identifiers

NCT03982290

17MMHIS193e

Details and patient eligibility

About

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.

Full 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.

Enrollment: 250 estimated patients

Sex: All

Ages: 30 months to 7 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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250 participants in 3 patient groups, including a placebo group

Lactobacillus plantarum PS128 (PS128)

Active Comparator group

Description:

Subjects will receive oral Lactobacillus plantarum PS128 capsules, 2 capsules per day, for 16 weeks.

Treatment:

Other: Probiotic, Lactobacillus plantarum PS128

Placebo

Placebo Comparator group

Description:

Subjects will receive oral placebo capsules, 2 capsules per day, for the first 8 weeks. The following 8 weeks, subjects will receive oral Lactobacillus plantarum PS128 capsules, 2 capsules per day, for 8 weeks.

Treatment:

Other: Placebo, microcrystalline cellulose

Normal Control

No Intervention group

Description:

Normal control group are enrolled by invitation from the age and gender matched healthy children.