The Intervention of Lactobacillus Plantarum Probiotics in Adult Autistic Spectrum Disorders

NCT07118267 | Active Not Recruiting

• 2 other identifiers: 24MMHIS529e114-2314-B-195-015-
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Autism Disorder

Outcome Measures

Primary Outcomes (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.

  baseline to week8

Secondary Outcomes (7)

• The Autism Behavior Checklist-Taiwan, ABCT

  baseline to week 8

• Parent Target Symptom Rating Visual Analogue Scale, PTSVAS

  baseline to week 8

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

  baseline to week 8

• Quality of Life in Autism Questionnaire, QoLA

  baseline to week 8

• Visual Analogue Scale of Gastrointestinal Symptoms

  baseline to week 8

Study Arms (1)

Neuralli® MP

EXPERIMENTAL

Lactobacillus plantarum

Dietary Supplement: Lactiplantibacillus plantarum

Interventions

Lactiplantibacillus plantarum DIETARY_SUPPLEMENT

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

Neuralli® MP

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mackay Memorial Hospital: lead

Study Sites (1)

MacKay Memorial Hospital

Taipei, Taiwan, 10449, Taiwan

Location

MeSH Terms

Conditions

Autistic Disorder

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: August 5, 2025
• First Posted: August 12, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): August 31, 2027
• Last Updated: September 8, 2026

Record last verified: 2026-09

Locations

TW (1)