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

Primary Purpose

Autism

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Probiotic, Lactobacillus plantarum PS128
Placebo, microcrystalline cellulose
Sponsored by
Mackay Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism focused on measuring autism, preschool children

Eligibility Criteria

30 Months - 7 Years (Child)All SexesAccepts 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

Sites / Locations

  • Department of Pediatric Neurology, MacKay Children's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

No Intervention

Arm Label

Lactobacillus plantarum PS128 (PS128)

Placebo

Normal Control

Arm Description

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

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.

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

Outcomes

Primary Outcome Measures

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
Changes from hyperactivity subscale of Attention-Deficit/Hyperactivity Disorder Test (ADHDT) at week 8 and week 16
Inattention, hyperactive symptoms evaluation

Secondary Outcome Measures

Gastrointestinal symptoms recorded by using GI Severity Index (6-GSI) at week 8 and week 16
constipation, diarrhea, stool consistency, stool smell, flatulence, and abdominal pain
Change of total scores at week 8 and week 16 from baseline of Changes of Childhood Asperger Syndrome Test (CAST)
CAST for behavioral assessment
Change of total scores at week 8 and week 16 from baseline of Penn Interactive Peer Play Scale, (PIPPS)
PIPPS for communicative and interactive assessment
Change of total scores at week 8 and week 16 from baseline of Social Interaction Assessment Scale
Communicative and interactive assessment
Comparison of Microbiota composition between week 8 and baseline
Gut and oral microbiota analysis

Full Information

First Posted
May 31, 2019
Last Updated
June 10, 2019
Sponsor
Mackay Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03982290
Brief Title
Psychophysiological Effects of Lactobacillus Plantarum PS128 in Preschool Children With Autism Spectrum Disorder
Official Title
Psychophysiological Effects of Lactobacillus Plantarum PS128 in Preschool Children With Autism Spectrum Disorder: a Randomized, Placebo-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mackay Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism
Keywords
autism, preschool children

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Double-blinded, randomized, placebo-controlled
Masking
ParticipantCare ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lactobacillus plantarum PS128 (PS128)
Arm Type
Active Comparator
Arm Description
Subjects will receive oral Lactobacillus plantarum PS128 capsules, 2 capsules per day, for 16 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm 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.
Arm Title
Normal Control
Arm Type
No Intervention
Arm Description
Normal control group are enrolled by invitation from the age and gender matched healthy children.
Intervention Type
Other
Intervention Name(s)
Probiotic, Lactobacillus plantarum PS128
Other Intervention Name(s)
PS128
Intervention Description
PS128 capsules, 2 capsules per day
Intervention Type
Other
Intervention Name(s)
Placebo, microcrystalline cellulose
Other Intervention Name(s)
Placebo
Intervention Description
Placebo capsules, 2 capsules per day
Primary Outcome Measure Information:
Title
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
Description
ASEBA for behavioral assessment
Time Frame
Baseline, week 8 and week 16
Title
Changes from hyperactivity subscale of Attention-Deficit/Hyperactivity Disorder Test (ADHDT) at week 8 and week 16
Description
Inattention, hyperactive symptoms evaluation
Time Frame
Baseline, week 8 and week 16
Secondary Outcome Measure Information:
Title
Gastrointestinal symptoms recorded by using GI Severity Index (6-GSI) at week 8 and week 16
Description
constipation, diarrhea, stool consistency, stool smell, flatulence, and abdominal pain
Time Frame
Baseline, week 8 and week 16
Title
Change of total scores at week 8 and week 16 from baseline of Changes of Childhood Asperger Syndrome Test (CAST)
Description
CAST for behavioral assessment
Time Frame
Baseline, week 8 and week 16
Title
Change of total scores at week 8 and week 16 from baseline of Penn Interactive Peer Play Scale, (PIPPS)
Description
PIPPS for communicative and interactive assessment
Time Frame
Baseline, week 8 and week 16
Title
Change of total scores at week 8 and week 16 from baseline of Social Interaction Assessment Scale
Description
Communicative and interactive assessment
Time Frame
Baseline, week 8 and week 16
Title
Comparison of Microbiota composition between week 8 and baseline
Description
Gut and oral microbiota analysis
Time Frame
Baseline and week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Months
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hui-Ju Chen MD
Phone
02-25433535
Email
hjuchen0623@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hui-Ju Chen MD
Phone
02-25433535
Email
mmhcto@gmail.com; a6284@mmh.org.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hui-Ju Chen MD
Organizational Affiliation
Department of Pediatric Neurology, MacKay Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Pediatric Neurology, MacKay Children's Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hui-Ju Chen
Phone
02-25433535
Email
hjuchen0623@gmail.com
First Name & Middle Initial & Last Name & Degree
Hui-Ju Chen

12. IPD Sharing Statement

Plan to Share IPD
No

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

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