An Open-Label Phase I Clinical Trial of Vancomycin Followed by Familial Fecal Microbiota Transplant in Adult Subjects With Autism Spectrum Disorder (ASD)
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- ATEC
研究概览
简要总结
This is an open-label clinical trial to evaluate the benefits of familial fecal microbiota transplant following a 6-week treatment with Vancomycin in adult subjects with ASD for treatment of social deficits and language delays.
详细描述
This is an open-label clinical trial to evaluate the benefits of familial fecal microbiota transplant following a 6-week treatment with Vancomycin in adult subjects with ASD for treatment of social deficits and language delays. Participants are given FMT by colonoscopy
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject at least six years of age.
- •Subject has confirmed diagnosis of ASD based on the DSM-V.
- •Subject with ASD whose parents/caregiver/guardian/LAR can complete informed consent process.
- •A reliable parent or caregiver who can report the side effects and communicate effectively with the research team.
- •Comorbid gastrointestinal symptoms
- •Stable medications during the two months prior to enrollment.
- •Currently receiving interventions in the community or school for ASD.
- •If female and of childbearing potential, must be willing to utilize at least one highly effective method of birth control for the duration of the study. This includes oral birth control pills, contraceptive implants, and intra-uterine devices. Diaphragms and condoms are not considered highly effective. Subjects not of reproductive potential will be exempt (e.g., post-menopausal, surgically sterilized)
- •If male, and partner is of childbearing potential, must be willing to utilize at least one highly effective method of birth control for the duration of the study. This includes oral birth control pills, contraceptive implants, and intra-uterine devices Diaphragms and condoms are not considered highly effective. Subjects not of reproductive potential will be exempt (surgically sterilized)
排除标准
- •Female subjects who are pregnant, nursing, or intend to become pregnant during the study period.
- •Subjects whose caregivers are unable/unwilling to cooperate with the protocol requirements.
- •Subject will be excluded who are suffering with Rett syndrome and Childhood Disintegrative Disorder.
- •Other serious co-morbid medical disorders affecting brain function and behavior, including uncontrolled seizures.
- •Subjects unable to refrain from taking non-study antibiotics for the period of the study.
- •Subjects diagnosed with cancer, except small localized basal cell carcinoma.
- •Subjects known to abuse alcohol or drugs.
- •Subjects who have undergone gastric bypass or total colectomy, or who are scheduled for these procedures.
- •Infection with HIV.
- •Infection with Hepatitis B or C.
- •Allergy to benzodiazepine.
- •Inability to stop loperamide, diphenoxylatye/atropine, or cholestyramine before the study
- •Unable to stop opiate treatment unless on a stable dose including PRN dosing, and no dose increase planned for the duration of the study
- •Known positive stool cultures for enteropathogens including, but not limited to Shigella, Salmonella, and Campylobacter within 30 days before enrollment. (These infection agents should be treated in advance of participation in this FMT study because they affect the good flora).
- •Known stool studies positive for ova and/or parasites in 30 days prior to enrollment. (Same as above).
- •Planned travel outside United States during study period.
- •Hypersensitivity to vancomycin
- •Renal insufficiency
研究组 & 干预措施
Autism Subjects
These subjects will be administered fecal microbiota transplant by colonoscopy
干预措施: Fecal Microbiota Transplant (Biological)
结局指标
主要结局
ATEC
时间窗: 52 Weeks
Number of participants with changes in the Autism Treatment Evaluation Checklist scores
QoLA
时间窗: 52 Weeks
Number of participants with changes in Quality of Life Autism scores
CARS-2
时间窗: 52 Weeks
Number of participants with changes in Childhood Autism Rating Scale 2 scores
SRS-2
时间窗: 52 weeks
Number of patients with changes in SRS-2 scores
Behavioral changes
时间窗: 52 weeks
Changes in reported incidence of disturbances in non-core aspects of behavior or function
GSRS
时间窗: 52 weeks
Number of patients with reported changes in GSRS measure of GI disturbances
abbrvCDAI
时间窗: 52 weeks
Number of patients with changes in abbrevCDAI scores
HSPP
时间窗: 52 weeks
Number of subjects with changes in quality of life metric HSPP
次要结局
- Shannon Diversity Index(52 Weeks)
- Shannon Diversity Index(52 Weeks)
- Microbiome changes(52 weeks)