SHIFT: Studying HIV Immunology After Fecal Transplant
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- FMT-related adverse events
研究概览
简要总结
SHIFT is a randomized, longitudinal, prospective, blinded, three-arm study to determine the safety and tolerability of Fecal Microbiota Transplant (FMT) in HIV-infected participants on stable antiretroviral therapy (ART).
详细描述
This study is designed to test the safety and tolerability of Fecal Microbiota Transplant (FMT) in HIV infected individuals on stable antiretroviral therapy (ART). Additionally, the study will examine potential effects of FMT on HIV immune activation, which has been linked to HIV disease progression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women ages 18 - 75 years.
- •HIV-1 positive:
- •Ability and willingness of participant or legal guardian/representative to provide informed consent.
排除标准
- •Patients with a history of significant allergy to tree nuts, peanuts, shellfish, and/or eggs, vancomycin, levofloxacin, or metronidazole, chocolate/cocoa or gelatin; or unwillingness to ingest gelatin (in placebo capsules)
- •Use of investigational therapies or investigational vaccines within 90 days prior to study entry
- •Serious illness requiring systemic treatment and/or hospitalization within 30 days prior to entry
- •History of positive HCV antibody with detectable HCV RNA in plasma within 48 weeks prior to study entry.
- •History of positive HBsAg within 48 weeks prior to study entry
- •Liver cirrhosis, history of C. difficile infection, history of inflammatory bowel disease, bariatric surgery, total colectomy, colon or rectal anastomosis, bowel resection, or current colostomy.
- •Current diagnosis of diabetes
- •Either breastfeeding or pregnant within 24 weeks prior to study entry
- •Tendinopathy or peripheral neuropathy (potentially exacerbated by antibiotic pretreatment)
- •Use of immunosuppressives, immune modulators, or antineoplastic agents for more than 3 consecutive days within the 60 days prior to study entry.
- •Use of probiotics and prebiotics (supplements and products) within 30 days of the study. Yogurt with live cultures is allowed.
- •Diagnosed bacterial enteric infection within 30 days prior to study entry.
- •Acute diarrhea within 30 days of study entry.
- •Weight loss or gain of more than 25 pounds in the 24 weeks prior to study entry.
研究组 & 干预措施
Arm A
Weekly placebo (for Fecal Inoculum Capsule) treatment with placebo pre-treatment.
干预措施: Placebo (for Fecal Inoculum Capsule) (Biological)
Arm A
Weekly placebo (for Fecal Inoculum Capsule) treatment with placebo pre-treatment.
干预措施: Antibiotic Placebo (Drug)
Arm B
Weekly Fecal Inoculum Capsule treatment with placebo pre-treatment.
干预措施: Fecal Inoculum Capsule (Biological)
Arm B
Weekly Fecal Inoculum Capsule treatment with placebo pre-treatment.
干预措施: Antibiotic Placebo (Drug)
Arm C
Weekly Fecal Inoculum Capsule treatment with antibiotic pre-treatment.
干预措施: Fecal Inoculum Capsule (Biological)
Arm C
Weekly Fecal Inoculum Capsule treatment with antibiotic pre-treatment.
干预措施: Antibiotic (Drug)
结局指标
主要结局
FMT-related adverse events
时间窗: 30 weeks
Safety of FMT in stably suppressed HIV infected recipients on ART
次要结局
- Microbiome structure(30 weeks)
- Immune and metabolic markers(30 weeks)
研究者
DOUGLAS KWON
Principal Investigator
Massachusetts General Hospital