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Trial registered on ANZCTR


Registration number
ACTRN12616001002471
Ethics application status
Approved
Date submitted
5/07/2016
Date registered
28/07/2016
Date last updated
12/04/2019
Date data sharing statement initially provided
12/04/2019
Date results information initially provided
12/04/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Lactobacillus plantarum PS128 on behavior activity of children with autism
Scientific title
Evaluation of the effects of Lactobacillus plantarum PS128 capsules on behavior activity of autism children
Secondary ID [1] 289563 0
Nil known
Universal Trial Number (UTN)
U1111-1184-5325
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
autism spectrum disorder 299293 0
Condition category
Condition code
Mental Health 299286 299286 0 0
Autistic spectrum disorders
Alternative and Complementary Medicine 299287 299287 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Lactobacillus plantarum PS128 (PS128) is a recently reported psychobiotic. This trial aimed at investigating the effects of PS128 on behavior activity of children diagnosed with autism spectrum disorder (ASD). This trial will include 80 male subjects , aged from 7-15, who were diagnosed with ASD according to DSM-V and further confirmed diagnosis with Autism Diagnostic Interview-Revise (ADI-R). People who were prescribed to use antibiotics within 2 weeks or ingest probiotics products within 2 weeks will be excluded. Subjects will randomly assign to PS128 group or placebo group. After inclusion, the subjects will take PS128 (3 × 10^10 CFU) or placebo (microcrystalline cellulose) one capsule after breakfast and dinner (2 capsules per day) for 28 days. Symptoms improvement was evaluated on day 0 and on the endpoint. Clinical Global Impression-Severity (CGI-S) on day 0 and Clinical Global Impressions-Improvement (CGI-I) on day 28 were scored by principle investigator at examination room of clinic. Autism Behavior Checklist-Taiwan Version (ABCT), Social Responsiveness Scale (SRS), Child Behavior Checklist for Ages 6-18 (CBCL/6-18), and SNAP-IV parent rating scale were completed by parent of subjects on day 0 and day 28. Stool and urine samples were collected on day 0 and day 28.
Intervention code [1] 295159 0
Treatment: Other
Intervention code [2] 295336 0
Treatment: Drugs
Comparator / control treatment
The placebo control will be the control group of this trial. Participants in this group will be given 400 mg of microcrystalline cellulose in a capsule. Participants will consume orally 2 of the placebo daily with water for 28 days. All the scoring measured and sample collection are the same of all participants.
Control group
Placebo

Outcomes
Primary outcome [1] 298777 0
Autism Behavior Checklist-Taiwan Version;ABCT
Timepoint [1] 298777 0
Subjects are assessed at baseline and day 28 for changes between 2 timepoints.
Primary outcome [2] 298778 0
Social Responsiveness Scale;SRS
Timepoint [2] 298778 0
Subjects are assessed at baseline and day 28 for changes between 2 timepoints.
Primary outcome [3] 298779 0
Child Behavior Checklist;CBCL
Timepoint [3] 298779 0
Subjects are assessed at baseline and day 28 for changes between 2 timepoints.
Secondary outcome [1] 325176 0
Clinical Global Impressions-Improvement (CGI-I)
Timepoint [1] 325176 0
Subjects are assessed on day 28.
Secondary outcome [2] 325177 0
The inattention, hyperactivity and impulsivity status of subjects was evaluated by parents using Swanson, Nolan, and Pelham, Version IV (SNAP-IV) questionnaire.
Timepoint [2] 325177 0
Subjects are assessed at baseline and day 28 for changes between 2 timepoints.
Secondary outcome [3] 325178 0
Gut microbiota. Gut microbiomes composition were analyzed by sequencing stool DNA.
Timepoint [3] 325178 0
Analyzed for changes between 2 timepoints, baseline and day 28.
Secondary outcome [4] 325179 0
Urine metabolomics analysis. Nutritional and biological metabolites such as organic acids, fatty acids, vitamins, amino acids, small organic compounds, etc. were analyzed.
Timepoint [4] 325179 0
Analyzed for changes between 2 timepoints, baseline and day 28.

Eligibility
Key inclusion criteria
Male children, aged from 7-15, who were diagnosed with ASD according to DSM-V
Minimum age
7 Years
Maximum age
15 Years
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
People who were prescribed to use antibiotics within 2 weeks or ingest probiotics products within 2 weeks of study commencement will be excluded.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation was done by numbered containers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
This trial will include 80 subjects, 40 to be PS128 group and 40 to be placebo group. All the outcomes will be analyzed by SPSS or SAS. As a pilot study, the sample size was not calculated by achieving any objects.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 7985 0
Taiwan, Province Of China
State/province [1] 7985 0

Funding & Sponsors
Funding source category [1] 293936 0
Commercial sector/Industry
Name [1] 293936 0
Bened Biomedical Co., Ltd.
Address [1] 293936 0
2F.-2, No.129, Sec. 2, Zhongshan N. Rd., Zhongshan Dist., Taipei City 10448, Taiwan, ROC
Country [1] 293936 0
Taiwan, Province Of China
Primary sponsor type
Individual
Name
Yen-Wenn Liu
Address
No.155, Sec.2, Linong Street, Taipei, 11221, Taiwan
Country
Taiwan, Province Of China
Secondary sponsor category [1] 292761 0
Individual
Name [1] 292761 0
Yu-Yu Wu
Address [1] 292761 0
3F., No.6, Sec. 2, Fuxing S. Rd., Da’an Dist., Taipei City 106, Taiwan
Country [1] 292761 0
Taiwan, Province Of China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295351 0
Institutional Review Board of Antai Medical Care Cooperation Antai Tian-Sheng Memorial Hospital
Ethics committee address [1] 295351 0
No.210, Sec. 1, Zhongzheng Rd., Donggang Township, Pingtung County 928, Taiwan (R.O.C.)
Ethics committee country [1] 295351 0
Taiwan, Province Of China
Date submitted for ethics approval [1] 295351 0
02/10/2015
Approval date [1] 295351 0
01/12/2015
Ethics approval number [1] 295351 0
15-075-A2

Summary
Brief summary
Psychobiotics is a group of probiotics which represents beneficial effects to mental health. Lactobacillus plantarum PS128 (PS128) is a recently published psychobiotic. This trial aimed at investigating the effects of PS128 on behavior activity of children diagnosed with autism spectrum disorder (ASD). This trial will include 80 male subjects , aged from 7-15, who were diagnosed with ASD according to DSM-V and further confirmed diagnosis with Autism Diagnostic Interview-Revise (ADI-R).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 66994 0
Dr Yu-Yu Wu
Address 66994 0
YuNing Psychiatry Clinic. 3F., No.6, Sec. 2, Fuxing S. Rd., Da’an Dist., Taipei City 106, Taiwan.
Country 66994 0
Taiwan, Province Of China
Phone 66994 0
+886-2-27080706
Fax 66994 0
Email 66994 0
ruthyuyuwu@gmail.com
Contact person for public queries
Name 66995 0
Dr Yen-Wenn Liu
Address 66995 0
Institute of Biochemistry and Molecular Biology, National Yang-Ming University. No.155, Sec.2, Linong Street, Taipei, 112 Taiwan, ROC
Country 66995 0
Taiwan, Province Of China
Phone 66995 0
+886-2-28267000 ext. 5641
Fax 66995 0
Email 66995 0
skywenn@gmail.com
Contact person for scientific queries
Name 66996 0
Dr Yen-Wenn Liu
Address 66996 0
Institute of Biochemistry and Molecular Biology, National Yang-Ming University. No.155, Sec.2, Linong Street, Taipei, 112 Taiwan, ROC
Country 66996 0
Taiwan, Province Of China
Phone 66996 0
+886-2-28267000 ext. 5641
Fax 66996 0
Email 66996 0
skywenn@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
Yes
Journal publication details
Publication date and citation/details [1] 1861 0
Nutrients 2019, 11(4), 820; https://doi.org/10.3390/nu11040820
Attachments [1] 1861 0
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary