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Investigators designed an open, two-arm study to compare oral vancomycin with a fecal microbiota transplant (FMT) from a fecal donor-unrelated donor mix (FURM) as treatments for the first Clostridium difficile infection (CDI) episode among hospitalized patients.
Investigators designed an open, two-arm study to compare oral vancomycin with an FMT-FURM as treatments for the first Clostridium difficile infection (CDI) episode among hospitalized patients. From each patient, a fecal sample was obtained at days 0, 3, and 7 after treatment. Specimens are cultured to isolate C. difficile, and C. difficile are assessed for the presence of genes encoding enterotoxin (tcdB), cytotoxin (tcdA), the binary toxin A (cdtA), binary toxin B (cdtB), and deletions within the negative regulator of toxin A and B production (tcdC) by polymerase chain reaction (PCR). The minimum inhibitory concentrations (MICs) of ciprofloxacin, moxifloxacin, erythromycin, clindamycin, vancomycin, metronidazole, linezolid, fidaxomicin, and tetracycline against C. difficile are measured using the agar dilution method. Fecal samples and FMT-FURM are analyzed by 16 subunit ribosomal ribonucleic acid (16S rRNA) metagenomic sequencing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vancomycin | Active Comparator | Patients in this arm received vancomycin 250mg every 6 hrs for 10-14 days |
|
| FMT-FURM | Experimental | Patients in this arm receive FMT-FURM |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FMT | Other | Patients in the FMT group received FMT-FURM |
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| Measure | Description | Time Frame |
|---|---|---|
| Decrease in number of evacuations | The cure of CDI was measured | up to a 2 days |
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Inclusion Criteria:
Exclusion Criteria:
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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 |
| D014640 | Vancomycin |
| D006020 | Glycopeptides |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
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Patients were randomized by a closed envelope method in a 1: 1 ratio to either oral vancomycin (every 6 h for 10-14 days) or a FMT-FURM
| Vancomycin | Drug | Patients in the vancomycin group received oral vancomycin (250 mg every 6 h for 10-14 days) |
|
|
| D010455 |
| Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |