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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2020-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Autism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Double-blinded, randomized, placebo-controlled

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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.

Study Groups

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Lactobacillus plantarum PS128 (PS128)

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

Group Type ACTIVE_COMPARATOR

Probiotic, Lactobacillus plantarum PS128

Intervention Type OTHER

PS128 capsules, 2 capsules per day

Placebo

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.

Group Type PLACEBO_COMPARATOR

Placebo, microcrystalline cellulose

Intervention Type OTHER

Placebo capsules, 2 capsules per day

Normal Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Probiotic, Lactobacillus plantarum PS128

PS128 capsules, 2 capsules per day

Intervention Type OTHER

Placebo, microcrystalline cellulose

Placebo capsules, 2 capsules per day

Intervention Type OTHER

Other Intervention Names

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PS128 Placebo

Eligibility Criteria

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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

Minimum Eligible Age

30 Months

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes