The Intervention of Lactobacillus Plantarum Probiotics in Adult Autistic Spectrum Disorders (NCT07118267) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
The Intervention of Lactobacillus Plantarum Probiotics in Adult Autistic Spectrum Disorders
Taiwan12 participantsStarted 2025-09-01
Plain-language 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.
Who can participate
Age range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Patient Clinical Global Impression of Improvement (CGI-I)