AutismNCT03982290
Psychophysiological Effects of Lactobacillus Plantarum PS128 in Preschool Children With Autism Spectrum Disorder
A study testing Probiotic, Lactobacillus plantarum PS128 in people with Autism, run by Mackay Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 months to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism
- What is being tested?
- Probiotic, Lactobacillus plantarum PS128
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Oct 2018to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 months to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Department of Pediatric Neurology, MacKay Children's Hospital
Taipei
Hui-Ju Chen, 02-25433535, hjuchen0623@gmail.com
Hui-Ju Chen
About this study
Official title: Psychophysiological Effects of Lactobacillus Plantarum PS128 in Preschool Children With Autism Spectrum Disorder: a Randomized, Placebo-controlled Trial
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.
Read the 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.
- Conditions
- Autism
- Being tested
- Probiotic, Lactobacillus plantarum PS128, Placebo, microcrystalline cellulose
- Keywords
- autism, preschool children
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic, Lactobacillus plantarum PS128Other
Also called PS128
PS128 capsules, 2 capsules per day
Placebo, microcrystalline celluloseOther
Also called Placebo
Placebo capsules, 2 capsules per day
| Study group | Role | What they receive |
|---|---|---|
| Lactobacillus plantarum PS128 (PS128) | Active comparator | Subjects will receive oral Lactobacillus plantarum PS128 capsules, 2 capsules per day, for 16 weeks. Receives: 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. Receives: Other: Placebo, microcrystalline cellulose |
| 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 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
Measured: 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
Measured: 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
constipation, diarrhea, stool consistency, stool smell, flatulence, and abdominal pain
Measured: 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)
CAST for behavioral assessment
Measured: 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)
PIPPS for communicative and interactive assessment
Measured: Baseline, week 8 and week 16
Change of total scores at week 8 and week 16 from baseline of Social Interaction Assessment Scale
Communicative and interactive assessment
Measured: Baseline, week 8 and week 16
Comparison of Microbiota composition between week 8 and baseline
Gut and oral microbiota analysis
Measured: Baseline and week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2019
- Study start1 Oct 2018
- Primary completionDec 2019 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Double-blinded, randomized, placebo-controlled
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mackay Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hui-Ju Chen, Mackay Memorial Hospital
- Investigators
- Hui-Ju Chen MD, Principal investigator, Department of Pediatric Neurology, MacKay Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03982290
- Sponsor's protocol ID
- 17MMHIS193e
- Status last verified
- Jun 2019
- First submitted
- 31 May 2019
- Last updated
- 11 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychophysiological Effects of Lactobacillus Plantarum PS128 in Preschool Children With Autism Spectrum Disorder: a Randomized, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT03982290
- Acronym / sponsor ID
- 17MMHIS193e
- Conditions
- Autism
- Keywords
- autism, preschool children
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Mackay Memorial HospitalUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 11 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Double-blinded, randomized, placebo-controlled
| Arm | Type | Receives |
|---|---|---|
| Lactobacillus plantarum PS128 (PS128) | Active comparator | Other: Probiotic, Lactobacillus plantarum PS128Subjects will receive oral Lactobacillus plantarum PS128 capsules, 2 capsules per day, for 16 weeks. |
| Placebo | Placebo comparator | Other: Placebo, microcrystalline celluloseSubjects 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 | No intervention | –Normal control group are enrolled by invitation from the age and gender matched healthy children. |
Who may qualify
- Ages
- 30 months to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Probiotic, Lactobacillus plantarum PS128Also: PS128PS128 capsules, 2 capsules per day | Other | Lactobacillus plantarum PS128 (PS128) |
| Placebo, microcrystalline celluloseAlso: PlaceboPlacebo capsules, 2 capsules per day | Other | Placebo |
Primary outcome
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
Time frame: Baseline, 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
Time frame: Baseline, week 8 and week 16
Inattention, hyperactive symptoms evaluation
5 secondary outcomes
Gastrointestinal symptoms recorded by using GI Severity Index (6-GSI) at week 8 and week 16
Time frame: 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)
Time frame: 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)
Time frame: Baseline, week 8 and week 16
Change of total scores at week 8 and week 16 from baseline of Social Interaction Assessment Scale
Time frame: Baseline, week 8 and week 16
Comparison of Microbiota composition between week 8 and baseline
Time frame: Baseline and week 8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2019.
- Individual participant dataSharing planned: No
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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.
Hui-Ju Chen MD principal investigator
Department of Pediatric Neurology, MacKay Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic, Lactobacillus plantarum PS128 in people with Autism, run by Mackay 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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 11 Jun 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hui-Ju Chen MD (02-25433535, hjuchen0623@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Baseline, week 8 and week 16). The study lists 2 primary outcomes in all. 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 11 Jun 2019.