Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Active Not Recruiting NCT07118267

The Intervention of Lactobacillus Plantarum Probiotics in Adult Autistic Spectrum Disorders

Conditions: Autism Disorder

Sex: All
Ages: 18 Years – 50 Years
Healthy volunteers: No
Phase: NA
Enrollment: 15
Sponsor: Mackay Memorial Hospital

Location: MacKay Memorial Hospital Taipei Taiwan

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).

Eligibility Criteria

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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07118267). StuddyBuddy aggregates publicly available trial information.