Effects of Low-FODMAP Diet and Probiotics on Gastrointestinal Symptoms, Behavior Problems, and Microbiota in Children With Autism Spectrum Disorder and Gastrointestinal Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Change in Aberrant Behavior Checklist (ABC) Irritability Subscale Score
研究概览
简要总结
The goal of this clinical trial was to evaluate whether a low-FODMAP diet and probiotic supplements could reduce gastrointestinal (GI) symptoms and behavior problems in children with autism spectrum disorder (ASD) who also experienced GI issues. The main questions it aimed to answer were:
Did a low-FODMAP diet and/or probiotics improve GI symptoms such as constipation, diarrhea, and abdominal pain?
Did these interventions help reduce behavior problems such as irritability, lethargy, stereotypy, hyperactivity, and speech disorder ?
Researchers compared two groups:
- Children who received a daily probiotic supplement containing 4 strains for 4 weeks
- Children who received both the probiotic supplement and followed a low-FODMAP diet
This comparison aimed to determine whether the combination of diet and probiotics had greater benefits than probiotics alone.
Participants:
Took the assigned intervention(s) for 4 weeks
Provided stool samples for gut microbiota analysis
Completed assessments of GI symptoms and behavior using validated questionnaires
详细描述
This randomized, controlled, parallel-group clinical trial aimed to investigate the effects of a low-FODMAP diet and multi-strain probiotic supplementation on gastrointestinal (GI) symptoms, behavioral problems, and gut microbiota composition in children with Autism Spectrum Disorder (ASD) who presented with concurrent GI complaints.
Children aged 6 to 12 years with clinically diagnosed ASD and GI symptoms were recruited. A total of 16 participants were randomly assigned into two equal groups (n=8 per group). One group received a probiotic supplement containing four bacterial strains daily for 4 weeks, while the second group received the same probiotic supplement in combination with a low-FODMAP diet over the same period. The randomization was stratified and allocation was blinded to the data analysts.
Interventions Probiotic group: A commercially available probiotic blend (containing Lactobacillus acidophilus, Bifidobacterium longum, Lactobacillus rhamnosus, and Saccharomyces boulardii) was administered once daily for 4 weeks.
Low-FODMAP + Probiotic group: In addition to the probiotic supplement, participants received individualized nutrition counseling and followed a standardized low-FODMAP diet protocol under dietitian supervision for 4 weeks.
Data Collection and Measures GI symptoms were assessed using the Pediatric Gastrointestinal Symptoms Questionnaire - Rome III Version (QPGS-RIII) and the Bristol Stool Scale (BSS).
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
- None
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with Autism Spectrum Disorder by a specialist at Marmara University Pendik Training and Research Hospital Child and Adolescent Psychiatry Clinic
- •Aged between 6 and 12 years
- •Diagnosed with functional gastrointestinal symptoms according to Rome IV criteria
- •Willing to participate by signing informed consent and assent forms (by both child and parent)
排除标准
- •Following any other dietary intervention at the time of study initiation
- •Routine use of prebiotics or probiotics
- •Use of antibiotics within the 4 weeks prior to the study
- •Presence of active diarrhea due to intestinal infection or similar condition
- •Diagnosis of other gastrointestinal diseases besides functional GI symptoms
结局指标
主要结局
Change in Aberrant Behavior Checklist (ABC) Irritability Subscale Score
时间窗: Baseline and after 4 weeks of intervention
Change in caregiver-reported irritability scores as measured by the Aberrant Behavior Checklist Irritability Subscale, a standardized behavioral rating scale.
Change in Aberrant Behavior Checklist (ABC) Hyperactivity Subscale Score
时间窗: Baseline and after 4 weeks of intervention
Change in hyperactivity scores, as assessed by the caregiver-completed Hyperactivity Subscale of the Aberrant Behavior Checklist (ABC), a standardized behavioral rating scale.
Change in Aberrant Behavior Checklist (ABC) Lethargy-Social Withdrawal Subscale Score
时间窗: Baseline and after 4 weeks of intervention
Change in lethargy-social withdrawal scores, as assessed by the caregiver-completed Lethargy-Social Withdrawal Subscale of the Aberrant Behavior Checklist (ABC), a standardized behavioral rating scale.
Change in Aberrant Behavior Checklist (ABC) Stereotypy Subscale Score
时间窗: Baseline and after 4 weeks of intervention
Change in stereotypy scores, as assessed by the caregiver-completed Stereotypy Subscale of the Aberrant Behavior Checklist (ABC), a standardized behavioral rating scale.
Change in Aberrant Behavior Checklist (ABC) Inappropriate Speech Subscale Score
时间窗: Baseline and after 4 weeks of intervention
Change in inappropriate speech scores, as assessed by the caregiver-completed Inappropriate Speech Subscale of the Aberrant Behavior Checklist (ABC), a standardized behavioral rating scale.
Change in Presence of Functional Gastrointestinal Symptoms as Measured by the QPGS-RIII
时间窗: Baseline and after 4 weeks of intervention
Change in the presence of any functional gastrointestinal symptoms as determined by caregiver responses to the Pediatric Gastrointestinal Symptoms Questionnaire - Rome III (QPGS-RIII), a validated diagnostic tool for functional gastrointestinal disorders in children.
Change in Aberrant Behavior Checklist (ABC) Irritability Subscale Score
时间窗: Baseline and after 4 weeks of intervention
Change in caregiver-reported irritability scores as measured by the Aberrant Behavior Checklist Irritability Subscale, a standardized behavioral rating scale.
Change in Aberrant Behavior Checklist (ABC) Hyperactivity Subscale Score
时间窗: Baseline and after 4 weeks of intervention
Change in hyperactivity scores, as assessed by the caregiver-completed Hyperactivity Subscale of the Aberrant Behavior Checklist (ABC), a standardized behavioral rating scale.
Change in Aberrant Behavior Checklist (ABC) Lethargy-Social Withdrawal Subscale Score
时间窗: Baseline and after 4 weeks of intervention
Change in lethargy-social withdrawal scores, as assessed by the caregiver-completed Lethargy-Social Withdrawal Subscale of the Aberrant Behavior Checklist (ABC), a standardized behavioral rating scale.
Change in Aberrant Behavior Checklist (ABC) Stereotypy Subscale Score
时间窗: Baseline and after 4 weeks of intervention
Change in stereotypy scores, as assessed by the caregiver-completed Stereotypy Subscale of the Aberrant Behavior Checklist (ABC), a standardized behavioral rating scale.
Change in Aberrant Behavior Checklist (ABC) Inappropriate Speech Subscale Score
时间窗: Baseline and after 4 weeks of intervention
Change in inappropriate speech scores, as assessed by the caregiver-completed Inappropriate Speech Subscale of the Aberrant Behavior Checklist (ABC), a standardized behavioral rating scale.
Change in Presence of Functional Gastrointestinal Symptoms as Measured by the QPGS-RIII
时间窗: Baseline and after 4 weeks of intervention
Change in the presence of any functional gastrointestinal symptoms as determined by caregiver responses to the Pediatric Gastrointestinal Symptoms Questionnaire - Rome III (QPGS-RIII), a validated diagnostic tool for functional gastrointestinal disorders in children.
次要结局
- Change in Gut Microbiota Alpha Diversity (Shannon Index)(Baseline and after 4 weeks of intervention)
- Change in Gut Microbiota Beta Diversity (UniFrac Analysis)(Baseline and after 4 weeks of intervention)
- Change in Relative Abundance of Specific Bacterial Genera(Baseline and after 4 weeks of intervention)
- Change in Gut Microbiota Alpha Diversity (Shannon Index)(Baseline and after 4 weeks of intervention)
- Change in Gut Microbiota Beta Diversity (UniFrac Analysis)(Baseline and after 4 weeks of intervention)
- Change in Relative Abundance of Specific Bacterial Genera(Baseline and after 4 weeks of intervention)
研究者
Pınar Polat
Doctor Dietitian
Marmara University Pendik Training and Research Hospital