A Randomized, Open-label, Pilot Study to Evaluate the Fecal Microbiota Transplantation (FMT) in the Treatment of Ulcerative Colitis
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in fecal microbiota diversity and genera as assessed by sequencing
研究概览
简要总结
The study is to evaluate the safety, feasibility, and preliminary efficacy of frozen FMT delivery via retention enema compared to lyophilized powder given in oral capsules as induction FMT in subjects with active UC. This study will also determine changes in microbiome (diversity and genera) and proportion of antibody-coated microbiota from baseline to after completion of FMT.
详细描述
Studies have shown that microbiota disturbances occur in patients with ulcerative colitis (UC). This study will evaluate safety and preliminary efficacy of microbiota replacement treatment in active UC, and changes in microbiome (diversity and genera) and proportion of antibody-coated microbiota from baseline to after completion of FMT. Studies have shown that microbiota disturbances occur in patients with ulcerative colitis (UC). This study will evaluate safety and preliminary efficacy of microbiota replacement treatment in active UC, and changes in microbiome (diversity and genera) and proportion of antibody-coated microbiota from baseline to after completion of FMT.
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
- 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
- •Diagnosis of active UC defined on clinical grounds (Partial Mayo score ≥ 3 with each subscore >1)
- •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 Human Chorionic Gonadotropin(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
- •Subjects with sever UC (Mayo score of >7)
- •Unable to take retention enema or 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.
- •Absolute neutrophil count (ANC) < 500IU/mL
研究组 & 干预措施
Experimental: PRIM-DJ2727 - FROZEN
干预措施: PRIM-DJ2727 - FROZEN (Drug)
Experimental: PRIM-DJ2727 - CAPSULES
干预措施: PRIM-DJ2727 - CAPSULES (Drug)
结局指标
主要结局
Change in fecal microbiota diversity and genera as assessed by sequencing
时间窗: Baseline,end of treatment (4 weeks after baseline)
Change in proportion of antibody-coated microbiota as assessed by the antibiotic susceptibility test
时间窗: Baseline,end of treatment (4 weeks after baseline)
Safety as assessed by the adverse events
时间窗: 6 months after last dose
Adverse events include death, life-threatening adverse event, hospitalization ≥ 24 hours, prolongation of existing hospitalization, substantial disruption of the ability to conduct normal life functions, congenital abnormally/birth defect, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions or other important events that jeopardize the patient and may require medical or surgical intervention (e.g. allergic bronchospasm requiring intensive treatment)
Disease severity as assessed by the Partial Mayo Score (PMS) for Ulcerative Colitis (UC)
时间窗: week 5
This is a 3 item questionnaire and each is measured from 0-3, for a maximum score of 9 a higher number indicating worse outcome
次要结局
- Change in fecal microbiota diversity and genera as assessed by sequencing(Baseline,end of treatment (4 weeks after baseline), 6 months)
- Change in quality of life as assessed by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ) score(baseline, week 5, early termination(if applicable))
- Change in anxiety and depression as assessed by the Hospital Anxiety and Depression Scale (HADS)(baseline, week 5, early termination(if applicable))
- Change in proportion of antibody-coated microbiota as assessed by the gut microbiota taxonomy by sequencing(Baseline,end of treatment (4 weeks after baseline), 6 months follow up)
研究者
Andrew Dupont
Professor
The University of Texas Health Science Center, Houston