ASDNCT07064538
Effects of Neuralli® MP on Self-Defined Outcomes in Adults With Autistic Traits
A study testing Neuralli® MP in people with ASD and Autism, run by Mackay Memorial Hospital at 1 site in Taiwan.
Trial summary
To evaluate the efficacy of Neuralli® MP in improving participant-defined outcomes in adults with autistic traits. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- ASD, Autism, Autistic Disorders Spectrum
- What is being tested?
- Neuralli® MP
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteTaiwan
- Study dates
- 19 Aug 2025to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants aged between 18 and 50 who exhibit autistic traits
- Those who have the willingness and ability to work but have not yet been able to enter a sheltered workshop at the Kanner Foundation
- The subjects, primary caregivers and institution staff are willing to participate in the study, and the primary caregivers and institution staff are willing to fill out the questionnaire and accept the interview
Who cannot join
- Those who have taken antibiotics or probiotic products in powder, capsule or tablet form within the past month are excluded.
- Participants currently receiving antibiotic treatment are also excluded.
- Individuals with a known allergy to dairy products.
- Individuals with immunodeficiency or compromised immune function.
- Individuals diagnosed with small intestinal bacterial overgrowth (SIBO)
- Ineligibility determined by PI, e.g. the individual starts any new medication or therapy, especially related to their autism, during this time.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Mixed-Methods Open-Label Trial Evaluating the Effects of Neuralli® MP on Self-Defined Outcomes in Adults With Autistic Traits
To evaluate the efficacy of Neuralli® MP in improving participant-defined outcomes in adults with autistic traits.
Read the detailed description
Autism spectrum disorder (ASD) is a common neurodevelopmental disorder characterized by pervasive difficulties since early childhood across reciprocal social communication and restricted, repetitive interests and behaviors. Although early ASD research focused primarily on children, there is increasing recognition that ASD is a lifelong neurodevelopmental disorder. However, although health and education services for children with ASD are relatively well established, service provision for adults with ASD is in its infancy. There is a lack of health services research for adults with ASD, including identification of comorbid health difficulties, rigorous treatment trials (pharmacological and psychological), development of new pharmacotherapies, investigation of transition and aging across the lifespan, and consideration of sex differences and the views of people with ASD. The health services research for adults with ASD is urgently warranted. In particular, research is required to better understand the needs of adults with ASD, including health, aging, service development, transition, treatment options across the lifespan, sex, and the views of people with ASD.
Lactiplantibacillus plantarum PS128 (PS128), showed ameliorative effects on depression- and anxiety-like behaviors in different mouse models. When administered to children with ASD, PS128 was shown to improve anxiety, rule-breaking behaviors, hyperactivity/impulsivity, social function, inflammation index, and autonomic function. PS128 supplementation has also been shown to improve depressive symptoms and sleep quality for adults with self-reported insomnia, as well as cortisol levels and anxiety. However, even for this well-studied probiotic, its specific effects on broader aspects of ASD, such as core symptoms, cognition, attention, and sleep have not been systematically investigated.
Therefore, this study is designed not only to examine the effects of Neuralli® MP (PS128) but, more importantly, to explore the wider health and support needs of adults with autistic traits. By doing so, this study aims to assess how PS128 may contribute to improving their overall quality of life and address a range of symptoms. Self determined outcomes is an important part of this study. This approach is valued because autism experiences are highly varied, so a one-size-fits-all outcome measure can miss what actually matters to each person.
- Conditions
- ASD, Autism, Autistic Disorders Spectrum
- Being tested
- Neuralli® MP
- Keywords
- Autistic traits, ASD
- Medical subject headings
- Autistic Disorder, Child Development Disorders, Pervasive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuralli® MPDietary supplement
Neuralli® MP containing 60 billion CFU (administered as two capsules per day)
| Study group | Role | What they receive |
|---|---|---|
| Neuralli® MP | Experimental | Not described Receives: Dietary Supplement: Neuralli® MP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Goal Attainment Scaling (GAS)
GAS is a method that can be used as a means of measuring outcome data from different contexts set out on a 5-point scale of -2 to +2.
It enables the data to be placed on a quantitative measurement scale thus tackling the problem of how to adequately identify and measure qualitative goal impact and attainment. This is very useful as it enables a linking of measures from the frontline to upper levels of an organization's management.
This assessment will be conducted weekly to determine how early the effects of the intervention can be observed.
Measured: weekly from baseline to week 8
Secondary outcomes (3)
The Autism Behavior Checklist-Taiwan (ABCT)
The Checklist scale contains 47 items: 8 items pertaining to sensory (sensation and perception), 11 items to relating (social connection), 12 items pertaining to body and object use (motor activity and rigid object use), 8 items pertaining to language (communication and interaction), and 8 items pertaining to social and self-Help (adaptability and self-care). The scoring method gives 1 point for each "Yes" answer. The higher the score, the more severe the autistic behaviors. This scale has favorable content consistency, with a Cronbach α value between 0.75 and 0.87, retest reliability at 0.89. The content validity and reliability of the scale are satisfactory.
Measured: from baseline to week 4 and week 8
Parent Target Symptom Rating Visual Analogue Scale (PTSVAS)
A 100mm horizontal scale will be used to evaluate the descriptions and ratings, with each 10mm segment representing one unit. The scale ranges from "very good" or "completely resolved" (0) to "worst" or "catastrophic worsening" (10), with 5 representing no change.
Measured: from baseline to week 4 and week 8
Quality of Life in Autism Questionnaire (QoLA)
The "Quality of Life in Autism Questionnaire" (QoLA) is a scale specifically designed for parents or caregivers of children with autism, aiming to assess their quality of life. The questionnaire consists of two parts:
Part A: Evaluates the overall sense of quality of life experienced by the parent or caregiver. This section includes various items such as: "I feel happy and content" and "I am satisfied with my social life." Part B: Assesses the impact of the child's autism symptoms or characteristics on the parent or caregiver. The items in this section aim to understand how the child's autistic traits affect family life and the parent's daily experiences.
The full questionnaire contains 48 items and is designed to comprehensively evaluate both the quality of life of the parent or caregiver and the impact of the child's autism symptoms on them.
Measured: from baseline to week 4 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 posted14 Jul 2025
- Study start19 Aug 2025
- Primary completion30 Apr 2026
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ASDStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mackay Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Bened Biomedical Co., Ltd.
- Responsible party
- Principal investigator, Shu-I Wu, Mackay Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07064538
- Sponsor's protocol ID
- 25CT027be
- Status last verified
- May 2026
- First submitted
- 11 Jul 2025
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mixed-Methods Open-Label Trial Evaluating the Effects of Neuralli® MP on Self-Defined Outcomes in Adults With Autistic Traits
- ClinicalTrials.gov ID
- NCT07064538
- Acronym / sponsor ID
- 25CT027be
- Conditions
- ASD, Autism, Autistic Disorders Spectrum
- Keywords
- Autistic traits, ASD
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Mackay Memorial HospitalUniversity, hospital or other
- Collaborators
- Bened Biomedical Co., Ltd.
- Study start
- 19 Aug 2025 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 14 Jul 2025 (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.
To evaluate the efficacy of Neuralli® MP in improving participant-defined outcomes in adults with autistic traits.
Detailed description
Autism spectrum disorder (ASD) is a common neurodevelopmental disorder characterized by pervasive difficulties since early childhood across reciprocal social communication and restricted, repetitive interests and behaviors. Although early ASD research focused primarily on children, there is increasing recognition that ASD is a lifelong neurodevelopmental disorder. However, although health and education services for children with ASD are relatively well established, service provision for adults with ASD is in its infancy. There is a lack of health services research for adults with ASD, including identification of comorbid health difficulties, rigorous treatment trials (pharmacological and psychological), development of new pharmacotherapies, investigation of transition and aging across the lifespan, and consideration of sex differences and the views of people with ASD. The health services research for adults with ASD is urgently warranted. In particular, research is required to better understand the needs of adults with ASD, including health, aging, service development, transition, treatment options across the lifespan, sex, and the views of people with ASD.
Lactiplantibacillus plantarum PS128 (PS128), showed ameliorative effects on depression- and anxiety-like behaviors in different mouse models. When administered to children with ASD, PS128 was shown to improve anxiety, rule-breaking behaviors, hyperactivity/impulsivity, social function, inflammation index, and autonomic function. PS128 supplementation has also been shown to improve depressive symptoms and sleep quality for adults with self-reported insomnia, as well as cortisol levels and anxiety. However, even for this well-studied probiotic, its specific effects on broader aspects of ASD, such as core symptoms, cognition, attention, and sleep have not been systematically investigated.
Therefore, this study is designed not only to examine the effects of Neuralli® MP (PS128) but, more importantly, to explore the wider health and support needs of adults with autistic traits. By doing so, this study aims to assess how PS128 may contribute to improving their overall quality of life and address a range of symptoms. Self determined outcomes is an important part of this study. This approach is valued because autism experiences are highly varied, so a one-size-fits-all outcome measure can miss what actually matters to each person.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neuralli® MP | Experimental | Dietary Supplement: Neuralli® MP |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Participants aged between 18 and 50 who exhibit autistic traits
- Those who have the willingness and ability to work but have not yet been able to enter a sheltered workshop at the Kanner Foundation
- The subjects, primary caregivers and institution staff are willing to participate in the study, and the primary caregivers and institution staff are willing to fill out the questionnaire and accept the interview
Key exclusion criteria (6 listed)
- Those who have taken antibiotics or probiotic products in powder, capsule or tablet form within the past month are excluded.
- Participants currently receiving antibiotic treatment are also excluded.
- Individuals with a known allergy to dairy products.
- Individuals with immunodeficiency or compromised immune function.
- Individuals diagnosed with small intestinal bacterial overgrowth (SIBO)
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 |
|---|---|---|
| Neuralli® MPNeuralli® MP containing 60 billion CFU (administered as two capsules per day) | Dietary supplement | Neuralli® MP |
Primary outcome
Goal Attainment Scaling (GAS)
Time frame: weekly from baseline to week 8
GAS is a method that can be used as a means of measuring outcome data from different contexts set out on a 5-point scale of -2 to +2. It enables the data to be placed on a quantitative measurement scale thus tackling the problem of how to adequately identify and measure qualitative goal impact and attainment. This is very useful as it enables a linking of measures from the frontline to upper levels of an organization's management. This assessment will be conducted weekly to determine how early the effects of the intervention can be observed.
3 secondary outcomes
The Autism Behavior Checklist-Taiwan (ABCT)
Time frame: from baseline to week 4 and week 8
Parent Target Symptom Rating Visual Analogue Scale (PTSVAS)
Time frame: from baseline to week 4 and week 8
Quality of Life in Autism Questionnaire (QoLA)
Time frame: from baseline to week 4 and week 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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.
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 Neuralli® MP in people with ASD and 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 3 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 2 Jun 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. 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?
This study is still under way. Results are not available in the source record yet.
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?
Goal Attainment Scaling (GAS) (time frame: weekly from baseline to week 8). 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 2 Jun 2026.