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- Title
Fecal Microbiota Transplantation Capsules with Targeted Colonic Versus Gastric Delivery in Recurrent Clostridium difficile Infection: A Comparative Cohort Analysis of High and Lose Dose.
- Authors
Allegretti, Jessica R.; Fischer, Monika; Sagi, Sashidhar V.; Bohm, Matthew E.; Fadda, Hala M.; Ranmal, Sejal R.; Budree, Shrish; Basit, Abdul W.; Glettig, Dean L.; de la Serna, Eva L.; Gentile, Amanda; Gerardin, Ylaine; Timberlake, Sonia; Sadovsky, Rotem; Smith, Mark; Kassam, Zain
- Abstract
<bold>Background: </bold>Fecal microbiota transplantation (FMT) is an effective therapy for recurrent Clostridium. difficile infection (rCDI). FMT capsules have emerged, and it is unknown if delivery location and dose impact efficacy.<bold>Methods: </bold>We compared two cohorts of patients receiving two capsule formulations: gastric release (FMTgr) and targeted colonic release (FMTcr) at two different sites. Cohort A received FMTgr at (1) high dose: 60 capsules and low dose: 30 capsules. Patients in Cohort B received FMTcr at (1) high dose: 30 capsules (2) low dose: 10 capsules. Clinical cure rates and adverse events were monitored through week 8. Paired t-tests were used to compare diversity pre- and post-FMT.<bold>Results: </bold>51 rCDI patients were enrolled. Cohort A contained n = 20 and Cohort B contained n = 31. Overall cure at week 8 for FMTgr was 75% (15/20) compared to 80.6% for FMTcr, (25/31), p = 0.63. Both formulations were safe with no serious adverse events. FMTcr was superior at increasing gut microbial diversity.<bold>Discussion: </bold>To our knowledge, this is the first study to compare targeted delivery of FMT capsules. While both capsules were safe and efficacious, microbial engraftment patterns were superior in FMTcr.
- Subjects
FECAL microbiota transplantation; CLOSTRIDIOIDES difficile; COHORT analysis; COMPARATIVE studies; MICROBIAL diversity; CLOSTRIDIUM disease treatment; COLON microbiology; PHARMACEUTICAL encapsulation; CLOSTRIDIUM diseases; HYDROGEN-ion concentration; RESEARCH methodology; MEDICAL cooperation; RESEARCH; STOMACH; TIME; EVALUATION research; TREATMENT effectiveness; DISEASE remission
- Publication
Digestive Diseases & Sciences, 2019, Vol 64, Issue 6, p1672
- ISSN
0163-2116
- Publication type
journal article
- DOI
10.1007/s10620-018-5396-6