Efficacy and Safety of Fecal Microbiota Transplantation for Severe Clostridium Difficile Associated Colitis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Number of Participants With Resolution of Severe CDAD
研究概览
简要总结
Clostridium difficile has become one of the leading causes of hospital acquired infections, and is associated with increased mortality. Patients with C. difficile associated disease (CDAD) possess deficiencies in 'normal' fecal microbial composition, most likely as a result of earlier antibiotic usage. The current standard of care treatment for severe C. difficile, which consists of antibiotics, does not restore the microbiota. Restoration of the normal colonic microbiota by fecal microbiota transplantation (FMT) may enable reversion colonic microbial population to a more 'normal'state and lead to cure.
A few patients develop severe CDAD which may be complicated by adynamic ileus, or toxic megacolon. The management in this context is based on limited data, and for some the only available option is sub-total colectomy.
Although FMT is by no means a new therapeutic modality, there is limited information on its use for the treatment of acute CDAD, including severe CDAD. Because of the high morbidity and mortality associated with treatment of patients with severe CDAD, and because the evidence supporting the current recommendations is weak and based upon the demonstration that FMT is an effective strategy to re-establish a balanced intestinal microbiota with resultant cure of recurrent CDAD, we propose to study the efficacy and safety of FMT for severe CDAD.
Patients with severe CDAD can be divided into two operational groups; those that have diarrhea and those that suffer from adynamic ileus. We propose to apply FMT through colonoscopy for all patients because current data suggest that the overall success rate of FMT for recurrent CDAD with lower gastrointestinal tract FMT was higher than FMT through the upper gastrointestinal tract. In addition, for patients with adynamic ileus and toxic megacolon (i.e., the population with the highest CDAD-associated morbidity and mortality), intra-colonic FMT administration is the preferred alternative.
详细描述
Screening and Consent - Index cases:
- Hospitalized patient with the diagnosis of severe CDAD
- At screening visit the study investigator(s) will explain the study in detail, answer any questions the candidate may have, and give the candidate a consent form to read and sign.
- After signing the consent form, the candidate subject will be asked to provide a complete medical history and undergo a physical examination.
- Blood will be drawn for a complete blood count (CBC) and bacterial culture
- Stool will be collected and archived for use for further analysis as deemed necessary by the principal investigator. All analyses will be performed in an anonymous coded method, without any disclosure of the patient identifiers.
Screening and Consent - Donors:
-
Identified by recipients, generally an intimate partner or adult family member
-
Willing to donate stool
-
Exclusion criteria (per questionnaire):
-
Had taken antibiotics within 90 days of the planned procedure
-
Fever, diarrhea, vomiting, or any other symptoms of infection, which occurred within the two weeks prior to the day of the procedure.
-
Known exposure to HIV or viral hepatitis (within the previous 12 months)
-
High-risk sexual behaviors (examples: sexual contact with anyone with HIV/AIDS or hepatitis, men who have sex with men, sex for drugs or money)
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Use of illicit drugs
-
Tattoo or body piercing within 6 months
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Incarceration within previous 12 months
-
Known current communicable disease
-
Risk factors for variant Creutzfeldt-Jakob disease
-
Gastrointestinal co-morbidities
-
History of inflammatory bowel disease
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History of irritable bowel syndrome, idiopathic chronic constipation, or chronic diarrhea
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History of gastrointestinal malignancy
-
Recent ingestion of a potential allergen (eg, nuts) where recipient has a known allergy to this agent
-
Systemic autoimmunity, for example, multiple sclerosis, connective tissue disease
-
Exclusion criteria (per laboratory assays):
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
- •Both genders are eligible for study
- •Age 18 years and older
- •Able to provide written, informed consent
- •Confirmed diagnosis of severe CDAD as defined above
排除标准
- •(If any of the following apply, the subject MUST NOT enter the study):
- •Pregnant or lactating women
- •Need for prolonged antibiotics for other cause
- •Other known etiology for diarrhea, or clinical infection with other known enteric pathogens
- •Active, chronic conditions such as: Inflammatory bowel disease, Crohn's disease, Short bowel syndrome, Ulcerative or ischemic colitis
- •Laxatives or motility-altering drugs within 12 hours of enrolment
- •Clinically unstable. Hemodynamic instability defined as hypotension (mean arterial pressure < 60) not responsive to fluids.
- •Any condition that, in the opinion of the investigator, would preclude safe participation in the trial or compromise the quality of the data obtained.
- •Immune suppression, HIV, hematological or solid malignancy (chemotherapy in the past 3 months).
- •Prior colon surgery
研究组 & 干预措施
fecal microbiota transplant
fecal microbiota transplantation
干预措施: fecal microbiota transplantation (Drug)
结局指标
主要结局
Number of Participants With Resolution of Severe CDAD
时间窗: 2 weeks
Resolution of diarrhea, time to decrease in elevated WBC count
Number of Participants With Relapse of CDAD
时间窗: 2 weeks
Number of Participants with evidence of relapse of C. diff. associated diarrhea
次要结局
- Morbidity(1 weeks)
- All Cause Mortality(30 days)
- Need for Colectomy(30 days)
研究者
STRAHILEVITZ JACOB
Senior physician
Hadassah Medical Organization