A Prospective, Randomized, Placebo-Controlled Pilot Study to Characterize the Intestinal Microbiome and to Evaluate the Safety and Fecal Microbiome Changes Following Twice Weekly Administration of Lyophilized PRIM-DJ2727 or Placebo Given Orally for 12 Weeks in Subjects With Nonalcoholic Fatty Liver Disease (NAFLD)
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Microbiome Diversity in Fecal Samples as Indicated by the Shannon Diversity Index
研究概览
简要总结
Potential subjects with non-alcoholic fatty liver disease (NAFLD) will be identified by gastroenterologists (study investigators). Twelve eligible subjects with NAFLD will be randomly assigned to receive either active fecal microbiota transplantation in orally administered capsules or Placebo capsules and dosed twice weekly for 12 weeks. .
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
- •≥ 18 years of age
- •For sexually active male and female subjects of childbearing potential, agree to use an effective method of birth control during the study.
- •For female subjects of childbearing potential, a negative urine Qualitative HCG pregnancy test at enrollment 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 study assessments and follow up visits.
- •A documented diagnosis of NAFLD without cirrhosis based on imaging or clinical judgment of a gastroenterologist or hepatologist.
- •History of diabetes mellitus
- •Has an attending physician who will provide non-transplant care for the subject.
- •Agrees to maintain a stable regimen including weight loss, exercise, medications to control lipids and glucose, and vitamin E therapy if already prescribed, during participation in the study
排除标准
- •Unable to take multiple capsules orally.
- •Alcohol consumption of greater than an average of one drink per day for women and two drinks per day for men.
- •Hemochromatosis.
- •Hepatic encephalopathy.
- •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)
- •Receipt of systemic non-topical antibiotic therapy within 14 days of treatment day
- •History of use of an investigational drug within 90 days prior to the screening visit.
- •Positive results for active HIV, Hepatitis B, or Hepatitis C infections.
- •Current history for active states of Inflammatory bowel disease, Irritable bowel syndrome, microscopic colitis, celiac disease, short gut syndrome, colostomy, colectomy, gastrointestinal fistulae or strictures.
- •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
Active group
Patients with NAFLD will receive orally fecal microbiota capsules from healthy donors
干预措施: PRIM-DJ2727 (Drug)
Placebo group
Placebo capsules will be identical to the active capsules, but not contain intestinal bacteria
干预措施: Placebo (Drug)
结局指标
主要结局
Microbiome Diversity in Fecal Samples as Indicated by the Shannon Diversity Index
时间窗: 10 months
The Shannon diversity index is used to characterize species diversity in a community. Shannon's index accounts for both abundance and evenness of the species present. A high index value would represent a diverse and equally distributed community, and lower values represent a less diverse community. A value of 0 would represent a community with just one species. Typical values are generally between 1.5 and 3.5.
Microbiome Richness in Fecal Samples as Indicated by the Number of Taxonomies per Participant
时间窗: 10 months
Number of Participants With an Increase in Flora Diversity in Fecal Samples
时间窗: 10 months
次要结局
- Changes in gut motility(6 months)
- Monitor subjects' health information(10 months)
研究者
Herbert DuPont, MD
Professor of Infectious Diseases
The University of Texas Health Science Center, Houston