Treating Gastrointestinal Problems in Children With Autism Using Beneficial Bacteria Treatment (BBT)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 主要终点
- Gastrointestinal Symptom Responsiveness Scale (GSRS)
研究概览
简要总结
This is an open-label clinical trial to investigate a combination therapy for treating gastrointestinal problems in children with autism spectrum disorders.
The combination therapy includes beneficial bacteria.
详细描述
This is an open-label clinical trial to evaluate the safety, tolerability, and feasibility of a combination therapy to treat gastrointestinal problems in children with autism spectrum disorders.
It involves a combination therapy including beneficial bacteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children ages 7-17 years
- •Diagnosis of autism per Autism Diagnostic Interview-Revised (ADI-R)
- •Moderate or Severe GI problems ( on the GSRS, a single score of 4 (severe) on any item, or a score of 3 (moderate) on two items, or a score of 2 (mild) or more on any 4 items
- •No changes in medications, supplements, diet, therapies, or education in last 3 months, and no intention to change them during clinical trial
- •General good physical health aside from gastrointestinal problems
- •Cognitive Ability to Provide Informed Assent
排除标准
- •Antibiotics in last 6 months
- •Probiotics in last 3 months
- •Single-gene disorder (Fragile X, etc.)
- •Major brain malformation
- •Tube feeding
- •Severe gastrointestinal problems that require immediate treatment (life-threatening)
- •Ulcerative Colitis, Crohn's Disease, diagnosed Celiac Disease, Eosinophilic Gastroenteritis, or similar conditions
- •Severely underweight/malnourished
- •Recent or scheduled surgeries
- •Current participation in other clinical trials
研究组 & 干预措施
Rectal Group
This group will receive some treatments rectally and some orally. The treatments include a combination of Vancomycin, MoviPrep, Prilosec, and human fecal material; processed, frozen.
干预措施: MoviPrep (Drug)
Oral Group
This group will receive all treatments orally. The treatments include a combination of Vancomycin, MoviPrep, Prilosec, and human fecal material; processed, frozen.
干预措施: oral Vancomycin (Drug)
Oral Group
This group will receive all treatments orally. The treatments include a combination of Vancomycin, MoviPrep, Prilosec, and human fecal material; processed, frozen.
干预措施: MoviPrep (Drug)
Oral Group
This group will receive all treatments orally. The treatments include a combination of Vancomycin, MoviPrep, Prilosec, and human fecal material; processed, frozen.
干预措施: Prilosec (Drug)
Oral Group
This group will receive all treatments orally. The treatments include a combination of Vancomycin, MoviPrep, Prilosec, and human fecal material; processed, frozen.
干预措施: human fecal material; processed, frozen administered orally (Biological)
Rectal Group
This group will receive some treatments rectally and some orally. The treatments include a combination of Vancomycin, MoviPrep, Prilosec, and human fecal material; processed, frozen.
干预措施: oral Vancomycin (Drug)
Rectal Group
This group will receive some treatments rectally and some orally. The treatments include a combination of Vancomycin, MoviPrep, Prilosec, and human fecal material; processed, frozen.
干预措施: human fecal material; processed, frozen; administered orally and rectally (Biological)
Rectal Group
This group will receive some treatments rectally and some orally. The treatments include a combination of Vancomycin, MoviPrep, Prilosec, and human fecal material; processed, frozen.
干预措施: Prilosec (Drug)
结局指标
主要结局
Gastrointestinal Symptom Responsiveness Scale (GSRS)
时间窗: Baseline and 10 weeks (end of treatment)
The GSRS is a measure of gastrointestinal symptoms. It includes 15 questions, rated on a Likert scale of 1-7, from no symptoms to severe symptoms, respectively (i.e., higher is worse). We report an average score for all 15 questions, so the possible range for the average score is also 1-7.
次要结局
- Short Sensory Profile(baseline and 10 weeks)
- Parent Global Impressions-Revised (PGI-R)(Baseline and 10 weeks (end of treatment))
- Blood Safety Markers (Assessment of Blood Chemistry Panel and Complete Blood Count)(Baseline and 10 weeks (end of treatment))
- Childhood Autism Rating Scale (CARS)(Baseline and 10 weeks (end of treatment))
- Social Responsiveness Scale (SRS)(Baseline and 10 weeks (end of treatment))
- Vineland Adaptive Behavior Scale (VABS)(baseline and 18 weeks (8 weeks after treatment stopped))
- Daily Stool Record (DSR)(Baseline and 10 weeks (end of treatment))