Probiotic-Lactobacillus rhamnosus GG Supplementation on Behavior, Quality of Life, and Gut Microbiome Composition in Children with Autism Spectrum Disorder: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Improvement in Overall Quality of Life (QoL):
研究概览
简要总结
Rationale: Autism Spectrum Disorder (ASD) is a complex neurodevelopmental condition often accompanied by behavioral challenges and gastrointestinal (GI) symptoms. Emerging evidence highlights a strong connection between the gut-brain axis, with disruptions in gut microbiota composition contributing to neurobehavioral symptoms in children with ASD. Lactobacillus rhamnosus GG (LGG), a well-studied probiotic, has demonstrated potential in enhancing gut integrity, reducing inflammation, and modulating the gut-brain axis. This study aims to address the gap in evidence on the impact of LGG supplementation on behavioral outcomes, quality of life, and gut microbiota in children with ASD.
Objective: The primary objective is to evaluate the effects of LGG supplementation on the overall quality of life (QoL) of children with ASD and their families. Secondary objectives include assessing improvements in behavioral symptoms, family functioning, and gut microbiota diversity.
Method: This is a triple-blind, randomized, placebo-controlled trial involving 140 children aged 3–14 years diagnosed with ASD (DSM-V criteria). Participants will be randomly assigned to receive either LGG (1 × 10^10 CFU/day) or a placebo for 12 weeks. Data will be collected at baseline and post-intervention using validated tools such as the Quality-of-Life Autism Questionnaire (QoLA), Childhood Behavior Checklist (CBCL), and 16S rRNA sequencing for gut microbiota analysis. Behavioral and QoL changes will be statistically evaluated, correlating findings with microbiota diversity and family dynamics.
This study is expected to provide novel insights into the dual action of LGG in managing both GI and neurobehavioral symptoms in ASD populations, paving the way for non-invasive therapeutic approaches.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 3.00 Year(s) 至 14.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Children aged 3 to 14 years 2 Confirmed diagnosis of Autism Spectrum Disorder ASD based on DSM V criteria 3 Written informed consent provided by parents or legal guardians 4 Participants and their families are willing to comply with study procedures and intervention schedule.
排除标准
- •1 Children with renal pulmonary cardiac or hepatic dysfunction that could impact study outcomes 2 Presence of intellectual disability or global developmental delay unrelated to Autism Spectrum Disorder ASD 3 Weight for length or height for age less than 3 standard deviations below the mean based on WHO growth charts 4 Recent use of antibiotics within two months prior to enrollment 5 Use of probiotics or probiotic supplements within the past six months 6 History of inflammatory bowel disease celiac disease eosinophilic disorders eg eosinophilic esophagitis or prior bowel surgery 7 Current use of chronic anti inflammatory medications within two months before enrollment 8 Families unable to adhere to study procedures intervention schedules or follow up assessments.
结局指标
主要结局
Improvement in Overall Quality of Life (QoL):
时间窗: Assessed at baseline (pre-intervention) and 12 weeks (post-intervention).
Metric: Measured using the Quality-of-Life Autism (QoLA) questionnaire, designed to assess the well-being of children with Autism Spectrum Disorder (ASD) and their families.
时间窗: Assessed at baseline (pre-intervention) and 12 weeks (post-intervention).
次要结局
- Behavioral Improvements:
- Family Functioning:
- Gut Microbiome Modulation:
研究者
Murchana Khound
AIIMS Guwahati