Road to Discovery for Combination Probiotic BB-12 With LGG (Different Doses) in Treating Autism Spectrum Disorder Disorders
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Effects of BB-12+LGG at different doses on adverse events (safety)
研究概览
简要总结
This protocol is a blinded randomized controlled study of the effects of BB-12 with LGG at different doses in 70 healthy children with autism spectrum disorders at lower and higher doses over an 56-day period and a 28- day observation period. The study is being conducted in order to assess safety and tolerability of the probiotic (BB-12 with LGG) at 2 different doses of BB-12 with LGG. Identifying effects on behaviors in healthy children with ASD using SRS-2 and ABC, GI symptoms using GI symptom severity index, and relevant biomarkers of inflammation, microbiota, and metabolites. Primary testing and procedures will be conducted at the University of Texas Health Science Center at Houston and Memorial Hermann.
Biomarker identification includes Integrative analysis of plasma metabolome and stool microbiota will be conducted with the collaboration of Dr. Ruth Ann Luna and Dr. Jim Versalovic at Alkek Center for Metagenomics and Microbiome Research, Department of Molecular Virology & Microbiology of Baylor College of Medicine.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
The head statistician and study pharmacist will be aware of randomization scheme. The investigators will use an adaptive minimization program for randomization that balances the 3 study arms with respect to distributions of sex and age (4-10 vs. 11-16 y.o.). Patients will be randomized to placebo, 1 billion CFU, and 10 billion CFU study arms at a ratio of 1:2:2. (Currently marketed over-the-counter probiotics typically contain 0.1-50 billion CFUs per dose.) The performance of our covariate adaptive randomization algorithm will be verified through simulation studies before implementation.
入排标准
- 年龄范围
- 4 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy children with autism spectrum disorders (4 - 16 years old) and gastrointestinal symptoms, based on the GI Severity Index, with no other recognized illness will be enrolled in this study. There will be no selection on the basis of age, race, or gender. Although the investigators anticipate the majority of subjects will be male and/or pre-pubertal, in females of childbearing potential, a pregnancy test (urine) will be performed on females participating (at each visit).
排除标准
- •Pregnancy or breastfeeding
- •Subjects taking immunosuppressive medications, including oral corticosteroids
- •A History of Positive result of HIV, Hepatitis B, and/or Hepatitis C test
- •Abnormal lab test results (Section 5.2)
- •Gastrointestinal diseases such as celiac disease, inflammatory bowel disease
- •Subjects with an allergy to antibiotics
- •Presence of fever or a pre-existing adverse event monitored in the study
- •Use of probiotics in the last 30 days
- •Acute diarrheal illness within the past 30 days
- •Recent (within 2 weeks) or current use of oral antibiotics /anti-fungals Current use of oral laxatives
- •Subjects with implanted prosthetic devices including prosthetic heart valves
- •The investigators will require that subject not take any other probiotic-containing products, including yogurt supplemented with probiotics during the study period.
研究组 & 干预措施
BB-12 with LGG (Lower Dose)
BB-12 with LGG (Multistrain probiotic; lower dose): 1 billion CFUs
干预措施: BB-12 with LGG (Lower Dose) (Drug)
Placebo
Maltodextrin
干预措施: Placebo (Drug)
BB-12 with LGG (Higher Dose)
BB-12 with LGG (Multistrain probiotic: higher dose): 10 billion CFUs
干预措施: BB-12 with LGG (Higher Dose) (Drug)
结局指标
主要结局
Effects of BB-12+LGG at different doses on adverse events (safety)
时间窗: 84 days
Adverse events (Safety) will be measured by case report form (survey) that are related to BB-12 with LGG (health-promoting bacteria) or placebo treatment. The symptom grade will detail the severity of adverse events.
Safety as Indicated by Number of Participants With Invasive Infection Resulting From the Administration of Probiotic
时间窗: from baseline to 56 days
Infection will be determined by clinical observations and temperature measurements made during the study period, as well as complete metabolic panel, complete blood count, and C-reactive protein (CRP) blood testing.
Number of Participants With Clinical Tolerance of the Probiotic
时间窗: from baseline to 56 days
Tolerance will be determined by assessment of symptoms, which will be monitored at clinical research center visits, as well as ability to remain on the treatment.
Safety as Indicated by Number of Participants With Toxicity Resulting From the Administration of Probiotic
时间窗: from baseline to 56 days
Toxicity will be determined by assessment of electrolyte status, renal function \[blood urea nitrogen (BUN) and creatinine (Cr), hepatic toxicity \[transaminases (AST, ALT) and total bilirubin\], and hematologic status \[CBC to measure hemoglobin and absolute neutrophil count\].
次要结局
- Effects of BB-12+LGG at different doses on irritability and maladaptive behaviors measured with the Social Responsiveness Scale-2(Days 1, 21, 56 and 84)
- Effects of BB-12+LGG at different doses on irritability and maladaptive behaviors with Aberrant Behavior Checklist (ABC)(Days 1, 21, 56 and 84)
研究者
J. Marc Rhoads
Director, Pediatric Gastroenterology
The University of Texas Health Science Center, Houston