Fecal Microbiota Transplantation Capsules with Targeted Colonic Versus Gastric Delivery in Recurrent Clostridium difficile Infection: A Comparative Cohort Analysis of High and Lose Dose

Jessica R. Allegretti, Monika Fischer, Sashidhar V. Sagi, Matthew Bohm, Hala M. Fadda, Sejal R. Ranmal, Shrish Budree, Abdul W. Basit, Dean L. Glettig, Eva L. de la Serna, Amanda Gentile, Ylaine Gerardin, Sonia Timberlake, Rotem Sadovsky, Mark Smith, Zain Kassam

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

Background: 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. Methods: 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. Results: 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. Discussion: 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.

Original languageEnglish (US)
JournalDigestive Diseases and Sciences
DOIs
StateAccepted/In press - Jan 1 2018

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Clostridium Infections
Clostridium difficile
Capsules
Stomach
Cohort Studies
Clostridium
Fecal Microbiota Transplantation

Keywords

  • Clostridium difficile infection
  • Fecal capsule
  • Fecal microbiota transplantation
  • Microbiome

ASJC Scopus subject areas

  • Physiology
  • Gastroenterology

Cite this

Fecal Microbiota Transplantation Capsules with Targeted Colonic Versus Gastric Delivery in Recurrent Clostridium difficile Infection : A Comparative Cohort Analysis of High and Lose Dose. / Allegretti, Jessica R.; Fischer, Monika; Sagi, Sashidhar V.; Bohm, Matthew; 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.

In: Digestive Diseases and Sciences, 01.01.2018.

Research output: Contribution to journalArticle

Allegretti, JR, Fischer, M, Sagi, SV, Bohm, M, Fadda, HM, Ranmal, SR, Budree, S, Basit, AW, Glettig, DL, de la Serna, EL, Gentile, A, Gerardin, Y, Timberlake, S, Sadovsky, R, Smith, M & Kassam, Z 2018, 'Fecal Microbiota Transplantation Capsules with Targeted Colonic Versus Gastric Delivery in Recurrent Clostridium difficile Infection: A Comparative Cohort Analysis of High and Lose Dose', Digestive Diseases and Sciences. https://doi.org/10.1007/s10620-018-5396-6
Allegretti, Jessica R. ; Fischer, Monika ; Sagi, Sashidhar V. ; Bohm, Matthew ; 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. / Fecal Microbiota Transplantation Capsules with Targeted Colonic Versus Gastric Delivery in Recurrent Clostridium difficile Infection : A Comparative Cohort Analysis of High and Lose Dose. In: Digestive Diseases and Sciences. 2018.
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abstract = "Background: 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. Methods: 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. Results: 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. Discussion: 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.",
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AU - Allegretti, Jessica R.

AU - Fischer, Monika

AU - Sagi, Sashidhar V.

AU - Bohm, Matthew

AU - Fadda, Hala M.

AU - Ranmal, Sejal R.

AU - Budree, Shrish

AU - Basit, Abdul W.

AU - Glettig, Dean L.

AU - de la Serna, Eva L.

AU - Gentile, Amanda

AU - Gerardin, Ylaine

AU - Timberlake, Sonia

AU - Sadovsky, Rotem

AU - Smith, Mark

AU - Kassam, Zain

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N2 - Background: 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. Methods: 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. Results: 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. Discussion: 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.

AB - Background: 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. Methods: 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. Results: 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. Discussion: 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.

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KW - Microbiome

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