Effects of Lactobacillus Plantarum PS128 in Children With ASD

Официальное название

Effects of Lactobacillus Plantarum PS128 in Children With Autism Spectrum Disorder

Обзор

Autism spectrum disorder (ASD) is a neurodevelopmental disorder that can cause significant social, communication and behavioral deficits. Probiotics are regarded as active microorganisms. With sufficient amounts, probiotics can regulate intestinal flora, intestinal permeability, inflammation and antioxidant reactions in the body. These reactions may further promote health, regulate metabolic disease progression and prevent complications. Lactobacillus plantarum PS128 (PS128) was reported to be a psychobiotic in several animal and human studies which modulated the levels of neurotransmitters in different brain areas. This study is to evaluate whether the consumption of PS128 can improve the symptoms of patients with ASD. The current randomized, placebo-controlled trial was conducted to investigate the psychophysiological effects of PS128 in school children with ASD.

Вмешательства

• Пищевая добавка PS128
  Each PS128 capsule contained \>3 × 10\^10 colony forming units (CFU) with microcrystalline cellulose and weights 425 ± 25 mg.
• Другое Placebo
  The placebo capsules only contained 425 ± 25 mg microcrystalline cellulose.

Первичные конечные точки

• Changes of total scores of Social Responsiveness Scale [Срок оценки: Baseline, Week 12 and Week 16]

Вторичные конечные точки (12)

• Changes of total scores of Repetitive Behavior Scale-Revised [Срок оценки: Baseline, Week 12 and Week 16]
• Changes of total scores of Child Behavior Checklist [Срок оценки: Baseline, Week 12 and Week 16]
• Changes of total scores of Adaptive Behavior Assessment System [Срок оценки: Baseline, week 12 and Week 16W]
• Changes in accuracy of Frith-Happe animation [Срок оценки: Baseline, Week 12 and Week 16]
• Changes in accuracy of Eyes task [Срок оценки: Baseline, Week 12 and Week 16]
• Changes of total scores of Aberrant Behavior Checklist [Срок оценки: Baseline, Week 12 and Week 16]
• Visual Analogue Scale for GI symptoms [Срок оценки: Baseline, week 12 and Week 16]
• Changes of total scores of Emotional Dysregulation Inventory [Срок оценки: Baseline, Week 12 and Week 16]
• Changes of total scores of Parenting Stress Index, Fourth Editon [Срок оценки: Baseline, Week 12 and Week 16]
• Assessment of Clinical Global Impression-Severity of Illness [Срок оценки: Baseline, Week 12 and Week 16]
• Assessment of Patient Global Impression of Change [Срок оценки: Week 12 and Week 16]
• Gut microbiota [Срок оценки: Baseline and Week 12]

Критерии участия

Критерии включения

• (1) Age 7 to 12 years old.
• (2) PS128 group and placebo group: Children with autism spectrum disorder, confirmed by Autism Diagnostic Observation Schedule.
• (3) Normal control group: Children without autism spectrum disorder.

Критерии исключения

• (1) Receiving antibiotics within one month.
• (2) Probiotics used in powder, capsule, or tablet in two weeks (except for Yogurt, Yogurt, Yakult and other related foods).
• (3) Patients with hepatobiliary gastrointestinal tract who have undergone surgery (except for hernia surgery and appendectomy)
• (4) Those with special diets (gluten-free, casein-free, high-protein, and ketogenic diet).
• (5) Those with a history of cancer.
• (6) Those who are allergic to lactic acid bacteria.
• (7) Not eligible judged by PI

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Другое

Центры проведения

Тайвань · 1 центр

• Chang Gung Memorial Hospital — Taoyuan

Идентификаторы

NCT: NCT05307744 · 202101416A3

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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