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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

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A Correction to this article was published on 18 February 2019

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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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Change history

  • 18 February 2019

    The original version of the article unfortunately contained an error in article title. The corrected title is ‘Fecal Microbiota Transplantation Capsules with Targeted Colonic Versus Gastric Delivery in Recurrent <Emphasis Type="Italic">Clostridium difficile</Emphasis> Infection: A Comparative Cohort Analysis of High and Low Dose’.

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Authors and Affiliations

  1. Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women’s Hospital, 75 Francis Street, Boston, MA, 02115, USA

    Jessica R. Allegretti

  2. Harvard Medical School, Boston, MA, USA

    Jessica R. Allegretti

  3. Division of Gastroenterology, Indiana University, Indianapolis, IN, USA

    Monika Fischer, Sashidhar V. Sagi & Matthew E. Bohm

  4. College of Pharmacy and Health Sciences, Butler University, Indianapolis, IN, USA

    Hala M. Fadda

  5. OpenBiome, Somerville, MA, USA

    Shrish Budree

  6. University of Cape Town, Cape Town, South Africa

    Shrish Budree

  7. Finch Therapeutics, Somerville, MA, USA

    Dean L. Glettig, Eva L. de la Serna, Amanda Gentile, Ylaine Gerardin, Sonia Timberlake, Rotem Sadovsky, Mark Smith & Zain Kassam

  8. Intract Pharma, London, UK

    Sejal R. Ranmal & Abdul W. Basit

  9. School of Pharmacy, University College London, London, UK

    Abdul W. Basit

Authors
  1. Jessica R. Allegretti
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  2. Monika Fischer
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  3. Sashidhar V. Sagi
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  4. Matthew E. Bohm
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  5. Hala M. Fadda
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  6. Sejal R. Ranmal
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  7. Shrish Budree
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  8. Abdul W. Basit
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  9. Dean L. Glettig
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  10. Eva L. de la Serna
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  14. Rotem Sadovsky
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  15. Mark Smith
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  16. Zain Kassam
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Contributions

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.

Corresponding author

Correspondence to Jessica R. Allegretti.

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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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Allegretti, J.R., Fischer, M., Sagi, S.V. et al. Fecal Microbiota Transplantation Capsules with Targeted Colonic Versus Gastric Delivery in Recurrent Clostridium difficile Infection: A Comparative Cohort Analysis of High and Lose Dose. Dig Dis Sci 64, 1672–1678 (2019). https://doi.org/10.1007/s10620-018-5396-6

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  • DOI: https://doi.org/10.1007/s10620-018-5396-6

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