A Study on Probiotic Formula in Autistic Children
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Probiotic formula capsule, placebo capsule, FMT capsule.
- Кому может быть актуально
- Состояния в реестре: Autism Spectrum Disorder. Базовые параметры: 3 лет — 14 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Китай
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
A Double-blind Randomized Clinical Trail Study on the Effectiveness and Safety of Probiotic Formula in Autistic Children With Gastrointestinal Symptoms
Обзор
A Randomized controlled double-blind clinical study on the effectiveness and safety of probiotic formula in Autistic children with gastrointestinal symptoms.
Подробное описание
Autism spectrum disorder (ASD) is a neurodevelopmental disorder of children with estimated prevalence of near 1% by WHO in 2022. To date, the cause and etiology of ASD is still unknown, and there is no proven effective pharmacological treatment for ASD. The gut microbiota has been proved to have great impact on neurological development, in this study, we aim to explore the effectiveness of safety of probiotic formula on ASD children, by comparing with placebo and fecal microbiota transplantation (FMT). This study will be a randomized, double-blind, placebo-controlled trial. Totally, 156 Autistic children with gastrointestinal symptoms will be enrolled and randomly allocated into three groups: probiotic formula group, fecal microbiota transplantation (FMT) group and placebo group. participants are treated with 4 probiotic formula/FMT/placebo capsules each day, for 84 days. Participants would be followed up at the 4th, 8th, 12th and 24th week after enrollment by simple physical examination, relevant scale questionaire (including Autism Behavior Checklist(ABC),Childhood Autism Rating Scale(CARS),Gastrointestinal Symptom Rating Scale(GSRS),Social Responsiveness Scale(SRS),Self-Rating Anxiety Scale(SAS) and Autism Diagnostic Observation Schedule(ADOS)), and blood and fecal samples collection.
Вмешательства
- Другое Probiotic formula capsule
The subjects take 4 capsules a day for 84 days. - Другое placebo capsule
The subjects take 4 capsules a day for 84 days. - Другое FMT capsule
The subjects take 4 capsules a day for 84 days.
Первичные конечные точки
- Changes in Behavioral Rating Scale (ABC) scores of children with autism in 12th week and baseline [Срок оценки: week 12]
Вторичные конечные точки (8)
- Changes in Childhood Autism Rating Scale(CARS) before and after treatment [Срок оценки: week 0,4,8,12,24]
- Changes in Social Responsiveness Scale(SRS) before and after treatment [Срок оценки: week 0,4,8,12]
- Changes in Self-Rating Anxiety Scale(SAS) before and after treatment [Срок оценки: week 0,4,8,12]
- Changes in Autism Diagnostic Observation Schedule(ADOS) before and after treatment [Срок оценки: week 0,4,8,12]
- Changes in Gastrointestinal Symptom Rating Scale(GSRS) before and after treatment [Срок оценки: week 0,4,8,12, 24]
- Changes in Serum neurotransmitters (5-HT、GABA、Dopamine) of children with autism before and after treatment [Срок оценки: week 0,12]
- Changes in gut microbiota of children with autism before and after treatment [Срок оценки: week 0,12]
- Changes in Behavioral Rating Scale (ABC) scores of children with autism before and after treatment [Срок оценки: week 0,4,8, 24]
Критерии участия
Критерии включения
- Children and adolescents aged 3-11 years old
- Clinical diagnosis of ASD, based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-V)
- Associated with gastrointestinal symptoms for at least 14 days (diarrhea, constipation, abdominal pain, bloating and/or food allergies/intolerances)
- With guardians who can fully understand the informed consent and voluntarily sign the written informed consent
Критерии исключения
- Antibiotics or probiotics used within 1 mont
- Serious gastrointestinal problems that require immediate treatment (such as life-threatening intestinal obstruction, intestinal perforation, intestinal bleeding
- Medications related to mental disorders or depression
- Relying on tube feeding
- Swallowing dysfunction that unable to take capsules
- History of severe allergies
- Paticipation in other clinical studies within 4 weeks
- Poor compliance and have difficulty in completing follow-up.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Двойное слепое
- Основная цель
- Лечение
Центры проведения
Китай · 1 центр
- Department of Gastroenterology, Daping Hospital, The Third Military Medical University — Чунцин
Идентификаторы
NCT: NCT06419530 · TMMU-DP-ASD-PMT-20240510