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Recurrent or refractory Clostridium difficile Infection (RCDI), with a recent increased incidence, is one of the most difficult and increasingly challenges for CDI. Since Fecal Microbiota Transplantation (FMT) has been accepted as the first-line therapy for RCDI, it is prudent to consider less invasive and more convenient means of administering FMT. The majority of reported FMT procedures have been performed with fresh or frozen stool suspensions via colonoscopy or nasojejunal tube. Nowadays, using acid-resistant hypromellose capsules, Youngster et al. significantly simplified the clinical practice of FMT and removed the need for invasive gastrointestinal procedures. However, to avoid undesirable disintegration, those capsules containing stool suspensions must be kept frozen all the time, which extremely limits their widespread application. The purpose of this study is to evaluate the efficacy and safety of freeze-dried, capsulized FMT for RCDI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Capsulized freeze-dried FMT | Experimental | Reconstitution of normal flora with capsulized freeze-dried fecal inoculum |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fecal Microbiota Transplantation | Drug | Fecal microbiota transplant from healthy, unrelated donor via freeze-dried capsule |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety is assessed by clinical symptoms, exam, signs (GI and systemic). | Safety is assessed by clinical symptoms, exam, signs (GI and systemic). | Up to 3 months post-FMT |
| Efficacy | Efficacy is defined as resolution of C. Difficile signs and symptoms off antibiotics for C. difficile. | Up to 3 months post-FMT |
| Measure | Description | Time Frame |
|---|---|---|
| Change of fecal bacteriology | Fecal microbiology is characterized by 16S rRNA gene-based analysis. | Up to 1 month post-FMT |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chao Ding, MD candidate | Contact | +86-25-80860036 | dingchao19910521@126.com | |
| Ning Li, MD | Contact | +86-25-80860089 | liningrigs@vip.sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Ning Li, MD | Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University | Recruiting | Nanjing | Jiangsu | 210002 | China |
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| ID | Term |
|---|---|
| D003015 | Clostridium Infections |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000069467 | Fecal Microbiota Transplantation |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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