NCT04373473招募中2 期
A Phase 2a, Randomized, Double-blinded, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Lyophilized Fecal Microbiota Transplantation (PRIM-DJ2727) Administered Orally in Combination With Standard of Care Therapy for Prevention of Relapse or Intestinal Inflammation in Adults With Ulcerative Colitis
The University of Texas Health Science Center, Houston1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2020年9月14日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Patients in remission after administering 12 weeks of PRIM-DJ2727 capsules will be measured by partial Mayo score ≤ 3
研究概览
简要总结
The purpose of the study is to evaluate the efficacy and safety of lyophilized PRIM-DJ2727 capsules given orally in subjects with ulcerative colitis at remission stage. This study will also include longitudinal analyses of recipient's gut microbiota taxonomy and metagenomics to determine potential associations with clinical outcomes in context of active FMT or placebo administration.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Adult ≥18 years of age
- •History of active UC in the past 12 months based on standard clinical, endoscopic, or histologic criteria.
- •Remission of UC based on clinical grounds (partial Mayo score of ≤2 with each subscore ≤1), and on stable maintenance therapy.
- •Sexually active male and female subjects of childbearing potential must agree to use an effective method of birth control during the study.
- •Female subjects of childbearing potential must have a negative urine Qualitative HCG pregnancy test at enrolment and on the Week 1, Day 1 of the Treatment prior to administration of study drug.
- •Willing and able to sign an informed consent form and attend all study-related clinic visits, assessments, and follow-up phone calls.
- •Subject has an attending physician who will provide the non-FMT care.
排除标准
- •Unable to take multiple capsules orally.
- •Females who are pregnant, breastfeeding, or planning to become pregnant during the study.
- •Receipt of systemic non-topical antibiotics within 14 days of treatment day
- •Positive results for active HIV, Hepatitis B, or Hepatitis C infections.
- •History of recurrent Clostridium difficile infection or FMT in the past 6-months.
- •History of other active gastrointestinal conditions such as irritable bowel syndrome, microscopic colitis, celiac disease, short gut syndrome, colostomy, colectomy, gastrointestinal fistulae or strictures, chronic parasitic infections, diverticulitis etc.
- •Known history of bile acid diarrhea
- •Compromised immune system (e.g. primary immune disorders or clinical immunosuppression due to a medical condition or medication e.g. taking oral prednisone >20 mg a day or prednisone-equivalent)
- •History of active cancer and/or ongoing chemotherapy (superficial non-metastatic cancers and maintenance chemotherapy are permitted).
- •History of use of an investigational drug within 90 days prior to the screening visit.
- •History of significant uncontrolled systemic disease that in the opinion of the study investigator could interfere with study participation and/or objectives.
- •Life expectancy of < 1 year.
- •In the opinion of investigator, subject for any reason, should be excluded from the study.
研究组 & 干预措施
Patients with UC will receive FMT capsules
Experimental
Patients with ulcerative colitis will receive fecal microbiota capsules from 3 healthy donors
干预措施: PRIM-DJ2727 (Drug)
Patients with UC will receive placebo
Placebo Comparator
Patients with ulcerative colitis will receive matching placebo capsules. Placebo capsule will be identical to PRIM-DJ2727 but will not contain intestinal bacteria.
干预措施: Placebos (Drug)
结局指标
主要结局
Patients in remission after administering 12 weeks of PRIM-DJ2727 capsules will be measured by partial Mayo score ≤ 3
时间窗: 9 months
次要结局
- Quality of life will be characterized by health-related quality of life score.(9 months)
- Subject-reported score in Hospital Anxiety and Depression Scale(9 months)
研究者
Herbert DuPont, MD
Professor of Infectious Diseases
The University of Texas Health Science Center, Houston
研究点 (1)
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