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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 E. 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
Original Article
  • 95 Downloads

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.

Keywords

Fecal microbiota transplantation Microbiome Clostridium difficile infection Fecal capsule 

Notes

Author’s contribution

JRA and ZK initiated study concept and design acquisition of data, analysis and interpretation of data, and drafting of the manuscript. YG, ST, and RS analyzed and interpreted microbiome-sequencing results. MF, MB, SS, SB, ES, DLG, ELS, AG participated in data acquisition, interpretation of data and critical revision of the manuscript. HMF, AWB, SRR, MS provided critical revision of manuscript.

Compliance with ethical standards

Conflict of interest

ZK YG, ST, MS and RS, DG, ELS are employees of Finch Therapeutics. JRA and MF consult for Finch Therapeutics. HMF receives royalties from Phloral. No other conflicts of interest to report for any authors relevant to the work presented in this manuscript.

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Copyright information

© Springer Science+Business Media, LLC, part of Springer Nature 2018

Authors and Affiliations

  • Jessica R. Allegretti
    • 1
    • 2
  • Monika Fischer
    • 3
  • Sashidhar V. Sagi
    • 3
  • Matthew E. Bohm
    • 3
  • Hala M. Fadda
    • 4
  • Sejal R. Ranmal
    • 8
  • Shrish Budree
    • 5
    • 6
  • Abdul W. Basit
    • 8
    • 9
  • Dean L. Glettig
    • 7
  • Eva L. de la Serna
    • 7
  • Amanda Gentile
    • 7
  • Ylaine Gerardin
    • 7
  • Sonia Timberlake
    • 7
  • Rotem Sadovsky
    • 7
  • Mark Smith
    • 7
  • Zain Kassam
    • 7
  1. 1.Division of Gastroenterology, Hepatology and EndoscopyBrigham and Women’s HospitalBostonUSA
  2. 2.Harvard Medical SchoolBostonUSA
  3. 3.Division of GastroenterologyIndiana UniversityIndianapolisUSA
  4. 4.College of Pharmacy and Health SciencesButler UniversityIndianapolisUSA
  5. 5.OpenBiomeSomervilleUSA
  6. 6.University of Cape TownCape TownSouth Africa
  7. 7.Finch TherapeuticsSomervilleUSA
  8. 8.Intract PharmaLondonUK
  9. 9.School of PharmacyUniversity College LondonLondonUK

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