NCT07845253尚未招募不适用
Effect of Limosilactobacillus Reuteri on Social Deficits in Children With Autistic Spectrum Disorder: a Double-blind, Randomized, Placebo-controlled, Parallel-group Clinical Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- BioGaia AB
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Changes in Social Responsiveness Scale-2 (SRS-2) score
研究概览
简要总结
This is a double-blind, randomized, placebo-controlled, parallel-group study in children with Autism Spectrum Disorder (ASD) to evaluate the effect of a probiotic product on the ASD symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Boys or girls aged between 4 to 12 years at screening.
- •ASD diagnosis confirmed by a qualified clinician according to DMS-5 criteria, M-CHAT used as a screening tool.
- •Parents/caregivers/legal guardians are ≥18 years.
- •Readiness and the opportunity for parents/caregivers/legal guardians to fill out a study diary, questionnaires, and report regularly during the intervention period.
- •Parents/caregivers/legal guardians with ability to understand and comply with the requirements of the study, as judged by the Investigator.
- •Parents/caregivers/legal guardians willing and able to give informed consent for their and their child's participation in the study.
排除标准
- •Neurological syndromes that could explain autism disorders.
- •Organic gastrointestinal disorders (e.g. IBD, peptic ulcers and cancer). Celiac disease is accepted
- •Any other severe clinically relevant disease or disorder which may affect the participation in the study, based on the investigator's judgement.
- •Allergy or intolerance to one of the excipients of the probiotic product.
- •Children with reported exposure to probiotic supplements in the 15 days prior to Screening Visit (V1).
- •Children with reported exposure to oral and/or systemic antibiotics in the 7 days prior to Screening Visit (V1).
- •Children with reported exposure to proton pump inhibitors in the 7 days prior to Screening Visit (V1).
- •Participation in other interventional clinical study.
研究组 & 干预措施
Probiotics
Experimental
Probiotic oil drops formulation. Administered once daily.
干预措施: Probiotics (Dietary Supplement)
Placebo
Placebo Comparator
Placebo oil drops formulation. Administered once daily.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Changes in Social Responsiveness Scale-2 (SRS-2) score
时间窗: From baseline to end of study (6 months)
Changes in the SRS-2 score in the L. reuteri group compared to the placebo group. The SRS-2 is a 65-item questionnaire, with higher scores indicating greater social impairment and severity of autism-related traits.
次要结局
- Proportion of responders(At 6 months)
- Change in Autism Diagnostic Observation Schedule, 2nd Ed (ADOS-2) Calibrated Severity Score (CSS) for Social Affect(From baseline to end of study (6 months))
- Change in total Autism Diagnostic Observation Schedule, 2nd Ed (ADOS-2) score(From baseline to end of study (6 months))
- Change in GI symptoms(From baseline to end fo study (6 months))
- Change in ABAS-2 score(From baseline to end fo study (6 months))
研究者
研究点 (1)
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