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Autism DisorderNCT07118267

The Intervention of Lactobacillus Plantarum Probiotics in Adult Autistic Spectrum Disorders

A study testing Lactiplantibacillus plantarum in people with Autism Disorder, run by Mackay Memorial Hospital at 1 site in Taiwan.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Phase I: Post-hoc Analysis and Longitudinal Follow-up Due to the inherent difficulty in recruiting the target number of individuals with Autism Spectrum Disorder (ASD) and the logistical challenges related to securing consensus from workshops, families, and teachers, the initial study phase has been modified. Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
Autism Disorder
What is being tested?
Lactiplantibacillus plantarum
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
1 Sep 2025to 31 Aug 2027
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

  • Those who have been diagnosed with autistic spectrum disorder aged 18~50 years old
  • Those whose primary contacts or caregiver (including family members or teachers) are willing to participate
  • Those whose primary contacts or caregivers can understand Mandarin and can answer relevant questions or questionnaires.

Who cannot join

  • Have taken antibiotics or are receiving antibiotic treatment within one month.
  • Have used probiotic products in powder, capsule or tablet form within two weeks (excluding yogurt, Yakult and other related foods).
  • Patients who have undergone hepatobiliary gastrointestinal surgery (except for colorectal polypectomy and appendectomy).
  • Past or current patients with inflammatory bowel disease.
  • Those with a history of cancer.
  • Those who are allergic to lactic acid bacteria products.
  • Those who are receiving parenteral nutrition.
  • Those who are evaluated by the principal investigator to be unsuitable to participate in the research.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site
  • MacKay Memorial Hospital

    Taipei, Taiwan, 10449

Other trials in Taiwan

About this study

Official title: The Intervention of Lactobacillus Plantarum Probiotics in Adult Patients With Autistic Spectrum Disorders Investigating Associations of Social Interactions, Quality of Life, and Gait Analysis: A Qualitative and Quantitative Mixed & Controlled Trial

Phase I: Post-hoc Analysis and Longitudinal Follow-up Due to the inherent difficulty in recruiting the target number of individuals with Autism Spectrum Disorder (ASD) and the logistical challenges related to securing consensus from workshops, families, and teachers, the initial study phase has been modified. The mixed-methods phase will now focus on leveraging the rich qualitative data already collected. We will seek ethical approval and consent from the fifteen preliminary study participants, their families, and teachers to conduct analysis of the existing interview content. Furthermore, these fifteen participants will be invited for a four-month follow-up assessment following the completion of the original 8-week intervention (post-test) to evaluate the persistence of observed changes after probiotic cessation. At this follow-up, teachers will re-evaluate the original three GAS goals, provide open-ended descriptions of the status of those target behaviors, and complete the Autism Behavior Checklist (ABCT). Parents will complete the full battery of questionnaires administered at the Week 8 endpoint.

Phase II: Controlled Trial The trial will consist of an 8-week intervention period. Participants will be assigned into the psychobiotic group and the control group. Gait analysis and subjective evaluations will be conducted at multiple time points, specifically, at Baseline and Week 8 (end of the first intervention period).

Read the detailed description

One neurodevelopmental disease that manifests before the age of three is autism. It is a range of widespread developmental problems that affect people from various socioeconomic backgrounds and ethnicities. Beginning in 2013, autism spectrum disorder (ASD) becomes the general diagnosis given to all children with autism, Asperger's syndrome, or other prevalent developmental abnormalities (DSM-5, APA). Over the past two decades, the frequency of ASD has steadily increased. Greater awareness of the problem or easier access to diagnostic services could be the cause of this.

Children with ASD have difficulties in social interaction, communication, and language skills with many children demonstrating delayed language development, unusual speech patterns, lack of spoken language, challenges in forming peer relationships, restrictive and repetitive behaviours such as rocking or hand flapping, or over- or under-reactive to stimuli. In adults with ASD, they may still have blunt or literal communication style, preference for solitude, difficulty understanding social cues, challenges in maintaining conversations, discomfort in social situations, adherence to routines, repetitive behaviors and sensory sensitivities similar to those seen in childhood but probably more controlled or masked. While the core characteristics of ASD remain consistent, the manifestation of symptoms can change with age and development. Talking with caregivers and other family members to find out about the person's early developmental history will help ensure an accurate diagnosis when diagnosing and evaluating people with ASD. Many adults with ASD struggle with finding and keeping employment, which can affect their independence and quality of life. ASD adults may also have co-occurring health conditions, such as anxiety and depression, which further impact daily functioning and overall well-being.

In recent years, the microbiota and the gut-brain axis (MGB, or the biochemical signaling pathway that connects the gastrointestinal tract and the nervous system) has attracted much attention in regulations and interactions of the nervous and immune systems. Intestinal microbes and their metabolites have been shown to regulate the human body through a series of biochemical and functional linkages. The microbiota is considered to be an essential organ of the human body for maintaining homeostasis. The composition of the intestinal flora is not only related to factors such as age, diet, or metabolic diseases, but also plays key roles in absorption, storage, metabolism, and maintenance of healthy immune function.

As for human research, Proteobacteria, Firmicutes, and Bacteroides are the three primary types of microorganisms found in the gut. They must be in harmony with one another; in fact, dysbiosis, an imbalance, can have an impact on gut health. Recent studies have started to investigate associations of microbiota and mental disorders, including depression or anxiety, autistic spectrum disorder, schizophrenia, or bipolar disorder.

ASD has primarily been examined in clinical trials conducted on children to examine the impacts of probiotics on neurological disorders. The main clinical trials on the effects of probiotics on children with ASD showed both the benefits and the drawbacks. Different probiotic dosages and results employing various beneficial microorganisms have been reported in trials looking into probiotic therapy in children with ASD.

While there's a growing body of research suggesting a potential link between gut health and neurodevelopmental disorders like ASD, most clinical trials of probiotics have been focusing on children. As of now, there aren't many large-scale, randomized controlled trials specifically targeting adults with ASD and probiotic interventions. However, the increasing recognition of the gut-brain axis and the potential benefits of probiotics in various conditions, including mental health, makes this an area of active research. The gut microbiome and its influence on brain function may differ between children and adults. The long-term effects of probiotic interventions on adult ASD symptoms need to be evaluated. The response to probiotic therapy can vary significantly among individuals due to the complex nature of ASD. While there's promising potential, more rigorous scientific research is required to establish the efficacy and safety of probiotics as a treatment for adults with ASD. However, research on the effects of probiotics or Lactobacillus plantarum on adults with ASD diagnosed in childhood still lacking. This study aims to examine whether Lactobacillus plantarum may be a possible new dietary approach for improving behavioral symptoms and enhancing the quality of life of caregivers among adults ASD diagnosed since childhood. This study also intends to outline the potential mechanisms by which the probiotics' direct or mediating effects can alleviate the microbiota-gut-grain dysfunction in the management of adults with ASD.

Conditions
Autism Disorder
Being tested
Lactiplantibacillus plantarum
Medical subject headings
Autistic Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lactiplantibacillus plantarumDietary supplement

    containing 60 billion CFU (administered as two capsules per day)

Study groups in NCT07118267
Study groupRoleWhat they receive
Neuralli® MPExperimentalLactobacillus plantarum
Receives: Dietary Supplement: Lactiplantibacillus plantarum

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Teacher Target Symptom Rating Visual Analogue Scale (TTSVAS)

    This is a tool used by teachers to 5 rate the severity of specific symptoms in their students. It typically involves a visual analogue scale (VAS), where teachers have to state three specific symptoms and mark a point on a line that represents the intensity of a particular symptom, such as irritability, hyperactivity, or anxiety, with score 10 being the most severe. If the symptoms they cared were to build positive behaviors, then score 10 would be the best performance of their students ("The British Pain Society. Outcome measures.," 2019). Teachers will be asked to list three items and quantify and describe baseline problems (frequency, duration, severity, interference with daily life) briefly in words.

    Measured: baseline to week8

Secondary outcomes (7)
  1. 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: baseline to week 8

  2. 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: baseline to week 8

  3. Teacher's Individualized Service Plans (ISP) goals and records

    Given the heterogeneous nature of ASD and the limitations of standardized scales in capturing treatment-sensitive functional change, the Goal Attainment Scale (GAS) will be employed as an individualized outcome measure only in the follow up study. The GAS targets will be formally derived from the participants' Individualized Service Plans (ISP), which outline the prioritized functional and behavioral goals set by the teachers and clinicians.

    Measured: baseline to week 8

  4. 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: baseline to week 8

  5. Visual Analogue Scale of Gastrointestinal Symptoms

    In order to identify relevant gastrointestinal discomfort after the consumption of psychobiotics or the placebo, a VAS with the scores from 0~10 was designed. 10 gastrointestinal symptoms, including dry mouth, difficulty swallowing, decreased appetite, nausea or vomiting, flatulence, gastralgia, upper and lower abdominal pain, constipation, and diarrhea, before and after the intervention were compared to determine the safety and tolerability of the intervention.

    Measured: baseline to week 8

  6. Parent Global Impression - Revised-2 (PGI-2)

    Assesses changes in 17 symptoms, such as language, attention span, cognition, gastrointestinal symptoms, sleep, behaviour, sociability, sensitivity, hyperactivity, aggression, eye contact, mood, and anxiety. The rating was done using a seven-point scale: -3 (much worse), -2 (worse), -1 (slightly worse), 0 (no change), 1 (slightly better), 2 (better) and 3 (much better).

    Measured: baseline to week 8

  7. Teacher Global Impression - Revised-2 (TGI-2)

    Assesses changes in 17 symptoms, such as language, attention span, cognition, 6 gastrointestinal symptoms, sleep, behaviour, sociability, sensitivity, hyperactivity, aggression, eye contact, mood, and anxiety. The rating was done using a seven-point scale: -3 (much worse), -2 (worse), -1 (slightly worse), 0 (no change), 1 (slightly better), 2 (better) and 3 (much better).

    Measured: baseline to week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2025
  2. Study start1 Sep 2025
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Aug 2027 (estimated)

Resources

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 (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07118267
Sponsor's protocol ID
24MMHIS529e
Other IDs
114-2314-B-195-015-
Status last verified
Sep 2026
First submitted
5 Aug 2025
Last updated
8 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Lactiplantibacillus plantarum in people with Autism Disorder, 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 8 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 8 Sep 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?

Teacher Target Symptom Rating Visual Analogue Scale (TTSVAS) (time frame: baseline to week8). 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 8 Sep 2026.

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