Autism Spectrum DisorderNCT05307744
Effects of Lactobacillus Plantarum PS128 in Children With ASD
A study testing PS128 in people with Autism Spectrum Disorder, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Autism spectrum disorder (ASD) is a neurodevelopmental disorder that can cause significant social, communication and behavioral deficits. Probiotics are regarded as active microorganisms. Read more about this study
- Who is it for?
- Ages 7 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- PS128
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Jul 2022to 3 Apr 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- (1) Age 7 to 12 years old.
- (2) PS128 group and placebo group: Children with autism spectrum disorder, confirmed by Autism Diagnostic Observation Schedule.
- (3) Normal control group: Children without autism spectrum disorder.
Who cannot join
- (1) Receiving antibiotics within one month.
- (2) Probiotics used in powder, capsule, or tablet in two weeks (except for Yogurt, Yogurt, Yakult and other related foods).
- (3) Patients with hepatobiliary gastrointestinal tract who have undergone surgery (except for hernia surgery and appendectomy)
- (4) Those with special diets (gluten-free, casein-free, high-protein, and ketogenic diet).
- (5) Those with a history of cancer.
- (6) Those who are allergic to lactic acid bacteria.
- (7) Not eligible judged by PI
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Lactobacillus Plantarum PS128 in Children With Autism Spectrum Disorder
Autism spectrum disorder (ASD) is a neurodevelopmental disorder that can cause significant social, communication and behavioral deficits. Probiotics are regarded as active microorganisms. With sufficient amounts, probiotics can regulate intestinal flora, intestinal permeability, inflammation and antioxidant reactions in the body. These reactions may further promote health, regulate metabolic disease progression and prevent complications. Lactobacillus plantarum PS128 (PS128) was reported to be a psychobiotic in several animal and human studies which modulated the levels of neurotransmitters in different brain areas. This study is to evaluate whether the consumption of PS128 can improve the symptoms of patients with ASD. The current randomized, placebo-controlled trial was conducted to investigate the psychophysiological effects of PS128 in school children with ASD.
- Conditions
- Autism Spectrum Disorder
- Being tested
- PS128, Placebo
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PS128Dietary supplement
Each PS128 capsule contained >3 × 10^10 colony forming units (CFU) with microcrystalline cellulose and weights 425 ± 25 mg.
PlaceboOther
The placebo capsules only contained 425 ± 25 mg microcrystalline cellulose.
| Study group | Role | What they receive |
|---|---|---|
| PS128 | Experimental | Subjects will take PS128 capsules every day (2 capsules/day, once) for 12 weeks. Receives: Dietary Supplement: PS128 |
| Placebo | Placebo comparator | Subjects will take placebo capsules every day (2 capsules/day, once) for 12 weeks. Receives: Other: Placebo |
| Normal control | No intervention | Normal control group are enrolled by invitation from the age and gender matched healthy children. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of Total Scores of Social Responsiveness Scale
Social Responsiveness Scale can measure the autism clinical severity with the range from 65-260. The lower scores stand for better social responsiveness.
Measured: Baseline, Week 12 and Week 16
Secondary outcomes (33)
Changes of Total Scores of Repetitive Behavior Scale-Revised
Repetitive Behavior Scale-Revised is a questionnaire that focuses on repetitive behavior. The score ranges from 0-129. The lower scores stand for lower repetitive behavior.
Measured: Baseline, Week 12 and Week 16
Changes of Total Scores of Child Behavior Checklist
Child Behavior Checklist is a parents' report questionnaire for behavioral and emotional problems. The score ranges from 0-240. The lower scores stand for better behavioral and emotional regulation.
Measured: Baseline, Week 12 and Week 16
Changes of Total Scores of Adaptive Behavior Assessment System
Adaptive Behavior Assessment System is a parents' report questionnaire for adaptive behavior. The score ranges from 9-171. The higher scores stand for better adaptive behavior.
Measured: Baseline, week 12 and Week 16
Changes in Accuracy of Frith-Happe Animation
A quick and objective test of Theory of Mind. 8 questions in total, the more correct questions stand for better Social Cognition.
Measured: Baseline, Week 12 and Week 16
Changes in Accuracy of Eyes Task
An advanced test for Theory of Mind. 43 questions in total, the more correct questions stand for better social skills.
Measured: Baseline, Week 12 and Week 16
Changes of Total Scores of Aberrant Behavior Checklist
Aberrant Behavior Checklist is a parents' report questionnaire for aberrant behavior. The score ranges from 0-174. The lower scores stand for less aberrant behavior.
Measured: Baseline, Week 12 and Week 16
Changes of Total Scores of Emotional Dysregulation Inventory
Emotional Dysregulation Inventory is a parents' report questionnaire for emotional dysregulation. The score ranges from 0-120. The lower scores stand for better emotional regulation.
Measured: Baseline, Week 12 and Week 16
Changes of Total Scores of Parenting Stress Index, Fourth Editon
Parenting Stress Index is a parents' report questionnaire for parenting stress. The score ranges from 0-180. The lower scores stand for lower parenting stress.
Measured: Baseline, Week 12 and Week 16
Assessment of Clinical Global Impression-Severity of Illness
The Clinical Global Impression (CGI) is a clinician rated measure of illness severity, improvement, and efficacy of treatment. The CGI-I is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. The score ranges from 1-7. CGI Improvement scale: 1=very much improved; 2=Much improved; 3=Minimally improved; 4=No change; 5=Minimally worse; 6=Much worse; 7=Very much worse.
Measured: Week 12 and Week 16
Assessment of Patient Global Impression of Change
The self-report measure Patient Global Impression of Change (PGIC) reflects a patient's belief about the efficacy of treatment. PGIC is a 7 point scale depicting a patient's rating of overall improvement. The score ranges from 1-7. Patients rate their change as "1=very much improved ," "2=much improved," "3=minimally improved," "4=no change," "5=minimally worse," "6=much worse," or "7=very much worse)."
Measured: Week 12 and Week 16
Gut Microbiota-Relative Abundance of Bifidobacterium Faecale
Collect the DNA of fecal flora to test the diversity and abundance of gut microbiota as well as short chain fatty acids in Stool samples. The 16S rRNA gene amplicons will be prepared following the Illumina protocol for preparing the 16S metagenomic sequencing library. Values represent percentages and range from 0 to 100%, with higher values indicating a higher relative abundance of the target bacterium in the gut microbiota
Measured: Baseline and Week 12
MRI T1
Brain structural volumes (cm²). The advanced processing and analysis of the MRI data have been outsourced to an external core facility. Due to resource scheduling and the prolonged timeline required for specialized image preprocessing, the data analysis is currently in progress and has not yet been finalized. Therefore, quantifiable results are unavailable for summary in the data table at this time.
Measured: Baseline and Week 12
Functional MRI (Resting-state/Biological Motion Task) - BOLD Signal
Blood-oxygen-level-dependent (BOLD) signal is a measurement used in fMRI, which reflects the neural activity. The advanced processing and analysis of the MRI data have been outsourced to an external core facility. Due to resource scheduling and the prolonged timeline required for specialized image preprocessing, the data analysis is currently in progress and has not yet been finalized. Therefore, quantifiable results are unavailable for summary in the data table at this time.
Measured: Baseline and Week 12
Diffusion Tensor Imaging (DTI) - FA
Fractional anisotropy (FA) is a measurement used in DTI, which reflects the movement of water molecules. FA ranges from 0 to 1, the higher FA value may represent more intact axons. The advanced processing and analysis of the MRI data have been outsourced to an external core facility. Due to resource scheduling and the prolonged timeline required for specialized image preprocessing, the data analysis is currently in progress and has not yet been finalized. Therefore, quantifiable results are unavailable for summary in the data table at this time.
Measured: Baseline and Week 12
Safety Assessment - Albumin
Safety is assessed function of liver and kidney such as albumin (3.5-5.4 g/dl).
Measured: Baseline and Week 12
Safety Assessment - Total Protein
Safety is assessed function of liver and kidney such as total protein (6.4-8.3 g/dl).
Measured: Baseline and Week 12
Safety Assessment - ALP
Safety is assessed function of liver and kidney such as ALP (135-320 U/L).
Measured: Baseline and Week 12
Safety Assessment - Total Bilirubin
Safety is assessed function of liver and kidney such as total bilirubin (0.3-1.2 mg/dl).
Measured: Baseline and Week 12
Safety Assessment - T-Cholesterol
Safety is assessed function of liver and kidney such as T-Cholesterol (<170 mg/dL).
Measured: Baseline and Week 12
Safety Assessment - Uric Acid
Safety is assessed function of liver and kidney such as uric acid (<7.0 mg/dl).
Measured: Baseline and Week 12
Safety Assessment - BUN
Safety is assessed function of liver and kidney such as BUN (7-25 mg/dl).
Measured: Baseline and Week 12
Safety Assessment - Creatinine
Safety is assessed function of liver and kidney such as creatinine (0.2-1.0 mg/dl).
Measured: Baseline and Week 12
Safety Assessment - AST
Safety is assessed function of liver and kidney such as AST (13-40 U/L).
Measured: Baseline and Week 12
Safety Assessment - ALT
Safety is assessed function of liver and kidney such as ALT (7-40 U/L).
Measured: Baseline and Week 12
Change in Levels of Exploratory Blood-based Biomarkers for Inflammatory Changes - MPO
Inflammatory is assessed via a composite measure of circulating cytokines - MPO (ng/mL)
Measured: Baseline and Week 12
Change in Levels of Exploratory Blood-based Biomarkers for Inflammatory Changes - IL-1β
Inflammatory is assessed via a composite measure of circulating cytokines - IL-1β (pg/mL)
Measured: Baseline and Week 12
Change in Levels of Exploratory Blood-based Biomarkers for Inflammatory Changes - TGF-β1
Inflammatory is assessed via a composite measure of circulating cytokines - TGF-β1 (pg/mL)
Measured: Baseline and Week 12
Change in Levels of Exploratory Blood-based Biomarkers for Inflammatory Changes - Eotaxin
Inflammatory is assessed via a composite measure of circulating cytokines - Eotaxin (pg/mL)
Measured: Baseline and Week 12
Change in Levels of Exploratory Blood-based Biomarkers for Inflammatory Changes - IL-6
Inflammatory is assessed via a composite measure of circulating cytokines - IL-6 (ng/mL)
Measured: Baseline and Week 12
Change in Levels of Exploratory Blood-based Biomarkers for Oxidative Stress Changes - Serotonin
Oxidative stress is assessed via Serotonin (ng/mL).
Measured: Baseline and Week 12
Change in Levels of Exploratory Blood-based Biomarkers for Oxidative Stress Changes - GABA
Oxidative stress is assessed via GABA (μmol/L).
Measured: Baseline and Week 12
Change in Levels of Exploratory Blood-based Biomarkers for Oxidative Stress Changes - Cortisol
Oxidative stress is assessed via Cortisol (6-10am 4.82-19.5, 4-8pm 2.47-11.9, μg/dl).
Measured: Baseline and Week 12
Gut Microbiota-Relative Abundance of Lactiplantibacillus Plantarum
Collect the DNA of fecal flora to test the diversity and abundance of gut microbiota as well as short chain fatty acids in Stool samples. The 16S rRNA gene amplicons will be prepared following the Illumina protocol for preparing the 16S metagenomic sequencing library. Values represent percentages and range from 0 to 100%, with higher values indicating a higher relative abundance of the target bacterium in the gut microbiota.
Measured: Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2022
- Study start15 Jul 2022
- Primary completion3 Apr 2024
- Study completion3 Apr 2024
Why it stopped: During COVID-19, study execution and participant compliance were significantly impacted. Lengthy procedures reduced parental and child willingness, causing slow recruitment. Due to these operational challenges, the study was terminated early.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Bened Biomedical Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05307744
- Sponsor's protocol ID
- 202101416A3
- Status last verified
- Feb 2025
- First submitted
- 14 Mar 2022
- Last updated
- 6 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Lactobacillus Plantarum PS128 in Children With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT05307744
- Acronym / sponsor ID
- 202101416A3
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: During COVID-19, study execution and participant compliance were significantly impacted. Lengthy procedures reduced parental and child willingness, causing slow recruitment. Due to these operational challenges, the study was terminated early.
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Collaborators
- Bened Biomedical Co., Ltd.
- Study start
- 15 Jul 2022 (actual)
- Primary completion
- 3 Apr 2024 (actual)
- Study completion
- 3 Apr 2024 (actual)
- First posted
- 1 Apr 2022 (actual)
- Results
- Posted 24 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Autism spectrum disorder (ASD) is a neurodevelopmental disorder that can cause significant social, communication and behavioral deficits. Probiotics are regarded as active microorganisms. With sufficient amounts, probiotics can regulate intestinal flora, intestinal permeability, inflammation and antioxidant reactions in the body. These reactions may further promote health, regulate metabolic disease progression and prevent complications. Lactobacillus plantarum PS128 (PS128) was reported to be a psychobiotic in several animal and human studies which modulated the levels of neurotransmitters in different brain areas. This study is to evaluate whether the consumption of PS128 can improve the symptoms of patients with ASD. The current randomized, placebo-controlled trial was conducted to investigate the psychophysiological effects of PS128 in school children with ASD.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PS128 | Experimental | Dietary Supplement: PS128Subjects will take PS128 capsules every day (2 capsules/day, once) for 12 weeks. |
| Placebo | Placebo comparator | Other: PlaceboSubjects will take placebo capsules every day (2 capsules/day, once) for 12 weeks. |
| Normal control | No intervention | –Normal control group are enrolled by invitation from the age and gender matched healthy children. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- (1) Age 7 to 12 years old.
- (2) PS128 group and placebo group: Children with autism spectrum disorder, confirmed by Autism Diagnostic Observation Schedule.
- (3) Normal control group: Children without autism spectrum disorder.
Key exclusion criteria (7 listed)
- (1) Receiving antibiotics within one month.
- (2) Probiotics used in powder, capsule, or tablet in two weeks (except for Yogurt, Yogurt, Yakult and other related foods).
- (3) Patients with hepatobiliary gastrointestinal tract who have undergone surgery (except for hernia surgery and appendectomy)
- (4) Those with special diets (gluten-free, casein-free, high-protein, and ketogenic diet).
- (5) Those with a history of cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PS128Each PS128 capsule contained >3 × 10^10 colony forming units (CFU) with microcrystalline cellulose and weights 425 ± 25 mg. | Dietary supplement | PS128 |
| PlaceboThe placebo capsules only contained 425 ± 25 mg microcrystalline cellulose. | Other | Placebo |
Primary outcome
Changes of Total Scores of Social Responsiveness Scale
Time frame: Baseline, Week 12 and Week 16
Social Responsiveness Scale can measure the autism clinical severity with the range from 65-260. The lower scores stand for better social responsiveness.
33 secondary outcomes
Changes of Total Scores of Repetitive Behavior Scale-Revised
Time frame: Baseline, Week 12 and Week 16
Changes of Total Scores of Child Behavior Checklist
Time frame: Baseline, Week 12 and Week 16
Changes of Total Scores of Adaptive Behavior Assessment System
Time frame: Baseline, week 12 and Week 16
Changes in Accuracy of Frith-Happe Animation
Time frame: Baseline, Week 12 and Week 16
Changes in Accuracy of Eyes Task
Time frame: Baseline, Week 12 and Week 16
Changes of Total Scores of Aberrant Behavior Checklist
Time frame: Baseline, Week 12 and Week 16
Changes of Total Scores of Emotional Dysregulation Inventory
Time frame: Baseline, Week 12 and Week 16
Changes of Total Scores of Parenting Stress Index, Fourth Editon
Time frame: Baseline, Week 12 and Week 16
Assessment of Clinical Global Impression-Severity of Illness
Time frame: Week 12 and Week 16
Assessment of Patient Global Impression of Change
Time frame: Week 12 and Week 16
Gut Microbiota-Relative Abundance of Bifidobacterium Faecale
Time frame: Baseline and Week 12
MRI T1
Time frame: Baseline and Week 12
Functional MRI (Resting-state/Biological Motion Task) - BOLD Signal
Time frame: Baseline and Week 12
Diffusion Tensor Imaging (DTI) - FA
Time frame: Baseline and Week 12
Safety Assessment - Albumin
Time frame: Baseline and Week 12
Safety Assessment - Total Protein
Time frame: Baseline and Week 12
Safety Assessment - ALP
Time frame: Baseline and Week 12
Safety Assessment - Total Bilirubin
Time frame: Baseline and Week 12
Safety Assessment - T-Cholesterol
Time frame: Baseline and Week 12
Safety Assessment - Uric Acid
Time frame: Baseline and Week 12
Safety Assessment - BUN
Time frame: Baseline and Week 12
Safety Assessment - Creatinine
Time frame: Baseline and Week 12
Safety Assessment - AST
Time frame: Baseline and Week 12
Safety Assessment - ALT
Time frame: Baseline and Week 12
Change in Levels of Exploratory Blood-based Biomarkers for Inflammatory Changes - MPO
Time frame: Baseline and Week 12
Change in Levels of Exploratory Blood-based Biomarkers for Inflammatory Changes - IL-1β
Time frame: Baseline and Week 12
Change in Levels of Exploratory Blood-based Biomarkers for Inflammatory Changes - TGF-β1
Time frame: Baseline and Week 12
Change in Levels of Exploratory Blood-based Biomarkers for Inflammatory Changes - Eotaxin
Time frame: Baseline and Week 12
Change in Levels of Exploratory Blood-based Biomarkers for Inflammatory Changes - IL-6
Time frame: Baseline and Week 12
Change in Levels of Exploratory Blood-based Biomarkers for Oxidative Stress Changes - Serotonin
Time frame: Baseline and Week 12
Change in Levels of Exploratory Blood-based Biomarkers for Oxidative Stress Changes - GABA
Time frame: Baseline and Week 12
Change in Levels of Exploratory Blood-based Biomarkers for Oxidative Stress Changes - Cortisol
Time frame: Baseline and Week 12
Gut Microbiota-Relative Abundance of Lactiplantibacillus Plantarum
Time frame: Baseline and Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Autism Spectrum Disorder
RecruitingPhase 1
Cannabidiol (CBD) in Adults With ASD
Autism Spectrum Disorder
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Sensory-integration Therapy Verses Augumented Reality-based Training in ASD
Autism Spectrum Disorder
Recruiting
Cumulative and Booster Effects of Multisession Prefrontal tDCS in ASD Adolescents
Transcranial Direct Current Stimulation, Autistic Spectrum Disorder
Not yet recruiting
"Family Resilience And Mind-body Enhancement" (FRAME): A Randomised Controlled Trial
Autism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PS128 in people with Autism Spectrum Disorder, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of Total Scores of Social Responsiveness Scale (time frame: Baseline, Week 12 and Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.