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

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:...

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Veröffentlicht in:Digestive diseases and sciences 2019-06, Vol.64 (6), p.1672-1678
Hauptverfasser: 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
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container_end_page 1678
container_issue 6
container_start_page 1672
container_title Digestive diseases and sciences
container_volume 64
creator 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
description 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.
doi_str_mv 10.1007/s10620-018-5396-6
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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. 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All Rights Reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c481t-1d72db17f56b76d9bc297da3b1a1768944fc616519f5966316af15a33882bf423</citedby><cites>FETCH-LOGICAL-c481t-1d72db17f56b76d9bc297da3b1a1768944fc616519f5966316af15a33882bf423</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s10620-018-5396-6$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s10620-018-5396-6$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>315,781,785,27926,27927,41490,42559,51321</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/30519847$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Allegretti, Jessica R.</creatorcontrib><creatorcontrib>Fischer, Monika</creatorcontrib><creatorcontrib>Sagi, Sashidhar V.</creatorcontrib><creatorcontrib>Bohm, Matthew E.</creatorcontrib><creatorcontrib>Fadda, Hala M.</creatorcontrib><creatorcontrib>Ranmal, Sejal R.</creatorcontrib><creatorcontrib>Budree, Shrish</creatorcontrib><creatorcontrib>Basit, Abdul W.</creatorcontrib><creatorcontrib>Glettig, Dean L.</creatorcontrib><creatorcontrib>de la Serna, Eva L.</creatorcontrib><creatorcontrib>Gentile, Amanda</creatorcontrib><creatorcontrib>Gerardin, Ylaine</creatorcontrib><creatorcontrib>Timberlake, Sonia</creatorcontrib><creatorcontrib>Sadovsky, Rotem</creatorcontrib><creatorcontrib>Smith, Mark</creatorcontrib><creatorcontrib>Kassam, Zain</creatorcontrib><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</title><title>Digestive diseases and sciences</title><addtitle>Dig Dis Sci</addtitle><addtitle>Dig Dis Sci</addtitle><description>Background Fecal microbiota transplantation (FMT) is an effective therapy for recurrent Clostridium. difficile infection (rCDI). 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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</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c481t-1d72db17f56b76d9bc297da3b1a1768944fc616519f5966316af15a33882bf423</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Analysis</topic><topic>Biochemistry</topic><topic>Capsules</topic><topic>Care and treatment</topic><topic>Clostridium Infections - diagnosis</topic><topic>Clostridium Infections - microbiology</topic><topic>Clostridium Infections - therapy</topic><topic>Cohort analysis</topic><topic>Colon - microbiology</topic><topic>Diseases</topic><topic>Fecal Microbiota Transplantation - adverse effects</topic><topic>Fecal Microbiota Transplantation - instrumentation</topic><topic>Female</topic><topic>Fidaxomicin</topic><topic>Gastroenterology</topic><topic>Gastrointestinal Microbiome</topic><topic>Health aspects</topic><topic>Hepatology</topic><topic>Humans</topic><topic>Hydrogen-Ion Concentration</topic><topic>Infection</topic><topic>Male</topic><topic>Medicine</topic><topic>Medicine &amp; 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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.</abstract><cop>New York</cop><pub>Springer US</pub><pmid>30519847</pmid><doi>10.1007/s10620-018-5396-6</doi><tpages>7</tpages><oa>free_for_read</oa></addata></record>
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subjects Adult
Aged
Aged, 80 and over
Analysis
Biochemistry
Capsules
Care and treatment
Clostridium Infections - diagnosis
Clostridium Infections - microbiology
Clostridium Infections - therapy
Cohort analysis
Colon - microbiology
Diseases
Fecal Microbiota Transplantation - adverse effects
Fecal Microbiota Transplantation - instrumentation
Female
Fidaxomicin
Gastroenterology
Gastrointestinal Microbiome
Health aspects
Hepatology
Humans
Hydrogen-Ion Concentration
Infection
Male
Medicine
Medicine & Public Health
Metronidazole
Microbiota
Microbiota (Symbiotic organisms)
Middle Aged
Oncology
Original Article
Relapse
Remission Induction
Stomach - microbiology
Time Factors
Transplant Surgery
Treatment Outcome
Young Adult
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
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