NCT07118267Active, not recruiting
The Intervention of Lactobacillus Plantarum Probiotics in Adult Autistic Spectrum Disorders
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
Source: ClinicalTrials.gov · Last updated 8 Sept 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 15 (actual)
- First submitted
- 5 Aug 2025
- Start date
- 1 Sept 2025
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Mackay Memorial Hospital
- Diseases
- Autism
- NCT number
- NCT07118267
What you commit to
- Study type: Interventional
- Participants enrolled: 15
- From 1 Sept 2025 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Have taken antibiotics or are receiving antibiotic treatment within one month.
- Patients who have undergone hepatobiliary gastrointestinal surgery (except for colorectal polypectomy and appendectomy).
- Those who are receiving parenteral nutrition.
Other illness
- Past or current patients with inflammatory bowel disease.
- Those with a history of cancer.
- Those who are allergic to lactic acid bacteria products.
Other
- Have used probiotic products in powder, capsule or tablet form within two weeks (excluding yogurt, Yakult and other related foods).
- Those who are evaluated by the principal investigator to be unsuitable to participate in the research.
Who the study is looking for
- 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.
Age in the registry: 18 years to 50 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| MacKay Memorial Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.