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

NCT03982290 | Unknown

• 1 other identifier: 17MMHIS193e
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism

Keywords

autism; preschool children

Outcome Measures

Primary Outcomes (2)

• 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

  ASEBA for behavioral assessment

  Baseline, week 8 and week 16

• Changes from hyperactivity subscale of Attention-Deficit/Hyperactivity Disorder Test (ADHDT) at week 8 and week 16

  Inattention, hyperactive symptoms evaluation

  Baseline, week 8 and week 16

Secondary Outcomes (5)

• Gastrointestinal symptoms recorded by using GI Severity Index (6-GSI) at week 8 and week 16

  Baseline, week 8 and week 16

• 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

• 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

• Change of total scores at week 8 and week 16 from baseline of Social Interaction Assessment Scale

  Baseline, week 8 and week 16

• Comparison of Microbiota composition between week 8 and baseline

  Baseline and week 8

Study Arms (3)

Lactobacillus plantarum PS128 (PS128)

ACTIVE COMPARATOR

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

Other: Probiotic, Lactobacillus plantarum PS128

Placebo

PLACEBO COMPARATOR

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.

Other: Placebo, microcrystalline cellulose

Normal Control

NO INTERVENTION

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

Interventions

Probiotic, Lactobacillus plantarum PS128 OTHER

PS128 capsules, 2 capsules per day

Also known as: PS128

Lactobacillus plantarum PS128 (PS128)

Placebo, microcrystalline cellulose OTHER

Placebo capsules, 2 capsules per day

Also known as: Placebo

Placebo

Eligibility Criteria

• Age: 30 Months - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mackay Memorial Hospital: lead

Study Sites (1)

Department of Pediatric Neurology, MacKay Children's Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Autistic Disorder

Interventions

Probiotics; microcrystalline cellulose

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Hui-Ju Chen MD

  Department of Pediatric Neurology, MacKay Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hui-Ju Chen MD

CONTACT

02-25433535; hjuchen0623@gmail.com

Hui-Ju Chen MD

CONTACT

02-25433535; mmhcto@gmail.com; a6284@mmh.org.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Attending Physician

Model Details: Double-blinded, randomized, placebo-controlled

Study Record Dates

• First Submitted: May 31, 2019
• First Posted: June 11, 2019
• Study Start: October 1, 2018
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2020
• Last Updated: June 11, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)