The Intervention of Lactobacillus Plantarum Probiotics in Adult Autistic Spectrum Disorders

NCT07118267 | Not Yet Recruiting

• 2 other identifiers: 24MMHIS529e114-2314-B-195-015-
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This is a qualitative and quantitative mixed-methods, open-label study, will involve 12 participants and their caregivers. Participants will also undergo blood exams and gait analysis, while caregivers will complete qualitative interviews and quantitative questionnaires on autistic symptoms, stress, anxiety, and quality of life. After the baseline assessments, participants will receive Lactobacillus plantarum for 8 weeks, followed by further evaluations at end point.

Conditions

Autism Disorder

Outcome Measures

Primary Outcomes (1)

• Patient Clinical Global Impression of Improvement (CGI-I)

  Patient Clinical Global Impression of Improvement (CGI-I) scale rated by the patient is a 7-point scale of improvement from 'very much improved' to 'very much worse'. 'Very much improved' means a better outcome.

  baseline to week8

Secondary Outcomes (4)

• The Autism Behavior Checklist-Taiwan, ABCT

  baseline to week 8

• Parent Target Symptom Rating Visual Analogue Scale, PTSVAS

  baseline to week 8

• Parenting Stress Index Fourth Edition Short Form, PSI-4-SF

  baseline to week 8

• Quality of Life in Autism Questionnaire, QoLA

  baseline to week 8

Study Arms (1)

probiotics

EXPERIMENTAL

Lactobacillus plantarum

Dietary Supplement: Lactiplantibacillus plantarum

Interventions

Lactiplantibacillus plantarum DIETARY_SUPPLEMENT

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

probiotics

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, 10449, Taiwan

Location

MeSH Terms

Conditions

Autistic Disorder

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Shu-I Wu, MD, PhD

CONTACT

886 975835215; shuiwu624@gmail.com

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): June 30, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: August 12, 2025

Record last verified: 2025-08

Locations

TW (1)