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Faecal Microbiota Transplant in Ulcerative Colitis (FMTUC) A Randomised Clinical Trial Feasibility Study / MAKI JITSUMURA

Swansea University Author: MAKI JITSUMURA

  • E-Thesis – open access under embargo until: 18th October 2025

DOI (Published version): 10.23889/SUthesis.61587

Abstract

Aims Restoring gut dysbiosis with faecal microbiota transplant (FMT) is of increasing interest as a therapeutic option in the management of Ulcerative colitis (UC). The aims of this thesis are to conduct a review of endpoints in UC clinical trials, to conduct a Phase II feasibility study to estimate...

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Published: Swansea 2022
Institution: Swansea University
Degree level: Doctoral
Degree name: M.D
Supervisor: Davies, Angharad ; Row, Paula
URI: https://cronfa.swan.ac.uk/Record/cronfa61587
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first_indexed 2022-10-19T09:14:52Z
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fullrecord <?xml version="1.0"?><rfc1807><datestamp>2022-10-19T16:47:57.8293036</datestamp><bib-version>v2</bib-version><id>61587</id><entry>2022-10-19</entry><title>Faecal Microbiota Transplant in Ulcerative Colitis (FMTUC) A Randomised Clinical Trial Feasibility Study</title><swanseaauthors><author><sid>e593989d2824903a0be32c3d7b7012aa</sid><firstname>MAKI</firstname><surname>JITSUMURA</surname><name>MAKI JITSUMURA</name><active>true</active><ethesisStudent>false</ethesisStudent></author></swanseaauthors><date>2022-10-19</date><abstract>Aims Restoring gut dysbiosis with faecal microbiota transplant (FMT) is of increasing interest as a therapeutic option in the management of Ulcerative colitis (UC). The aims of this thesis are to conduct a review of endpoints in UC clinical trials, to conduct a Phase II feasibility study to estimate the magnitude of treatment response to FMT in treatment-na&#xEF;ve patients with UC, to evaluate recruitment rates and to determine optimal study conditions and choice of endpoints for the phase III FMTUC study. Methods Narrative Review: The current consensus on endpoints in UC clinical trials were systematically reviewed using two indices: the Ulcerative Colitis Endoscopic Index of Severity (UCEIS) and the Ulcerative Colitis Disease Activity Index (UCDAI). FMTUC: Treatment-naive UC subjects were randomised to i) single enema, ii) five daily enemas or iii) control group. All groups received bowel decontamination prior to the FMT interventions. Subjects were assessed using qualitative assessment tools, blood tests, 16S RNA sequencing on faecal samples for 12 weeks. Endoscopic and histological assessments were also performed at baseline and week 12. The paired primary endpoints were remission of UC and successful engraftment of donor faecal microbiota at 12 weeks. Clinical remission was defined as Mayo score &#x2264; 2 with an endoscopic Mayo score of 0.Conclusions Eighteen patients were recruited between July 2016 and February 2020 and five achieved clinical remission. Clinical remission was more frequently observed among subjects with mild-moderate disease (P = 0.173). No correlations between FMT dose, frequency and clinical response were observed. The 16S evaluation demonstrated the altering the faecal microbiota after the interventions. This study also showed an inverse correlation between IL-10 and the severity of UC. The narrative review highlighted the importance of urgent universal consensus on both clinical remission and validated outcome tools, such as the UCEIS. This feasibility study of FMT successfully demonstrated potential for employing this method in the management of UC.</abstract><type>E-Thesis</type><journal/><volume/><journalNumber/><paginationStart/><paginationEnd/><publisher/><placeOfPublication>Swansea</placeOfPublication><isbnPrint/><isbnElectronic/><issnPrint/><issnElectronic/><keywords>Faecal Microbiota Transplant, FMT, Ulcerative Colitis, FMTUC</keywords><publishedDay>18</publishedDay><publishedMonth>10</publishedMonth><publishedYear>2022</publishedYear><publishedDate>2022-10-18</publishedDate><doi>10.23889/SUthesis.61587</doi><url/><notes/><college>COLLEGE NANME</college><CollegeCode>COLLEGE CODE</CollegeCode><institution>Swansea University</institution><supervisor>Davies, Angharad ; Row, Paula</supervisor><degreelevel>Doctoral</degreelevel><degreename>M.D</degreename><degreesponsorsfunders>Swansea Bay University Health Board</degreesponsorsfunders><apcterm/><funders/><projectreference/><lastEdited>2022-10-19T16:47:57.8293036</lastEdited><Created>2022-10-19T10:11:03.7370789</Created><path><level id="1">Faculty of Medicine, Health and Life Sciences</level><level id="2">Swansea University Medical School - Medicine</level></path><authors><author><firstname>MAKI</firstname><surname>JITSUMURA</surname><order>1</order></author></authors><documents><document><filename>Under embargo</filename><originalFilename>Under embargo</originalFilename><uploaded>2022-10-19T10:22:45.3438814</uploaded><type>Output</type><contentLength>9297331</contentLength><contentType>application/pdf</contentType><version>E-Thesis &#x2013; open access</version><cronfaStatus>true</cronfaStatus><embargoDate>2025-10-18T00:00:00.0000000</embargoDate><documentNotes>Copyright: The author, Dr. Maki Jitsumura, 2022.</documentNotes><copyrightCorrect>true</copyrightCorrect><language>eng</language></document></documents><OutputDurs/></rfc1807>
spelling 2022-10-19T16:47:57.8293036 v2 61587 2022-10-19 Faecal Microbiota Transplant in Ulcerative Colitis (FMTUC) A Randomised Clinical Trial Feasibility Study e593989d2824903a0be32c3d7b7012aa MAKI JITSUMURA MAKI JITSUMURA true false 2022-10-19 Aims Restoring gut dysbiosis with faecal microbiota transplant (FMT) is of increasing interest as a therapeutic option in the management of Ulcerative colitis (UC). The aims of this thesis are to conduct a review of endpoints in UC clinical trials, to conduct a Phase II feasibility study to estimate the magnitude of treatment response to FMT in treatment-naïve patients with UC, to evaluate recruitment rates and to determine optimal study conditions and choice of endpoints for the phase III FMTUC study. Methods Narrative Review: The current consensus on endpoints in UC clinical trials were systematically reviewed using two indices: the Ulcerative Colitis Endoscopic Index of Severity (UCEIS) and the Ulcerative Colitis Disease Activity Index (UCDAI). FMTUC: Treatment-naive UC subjects were randomised to i) single enema, ii) five daily enemas or iii) control group. All groups received bowel decontamination prior to the FMT interventions. Subjects were assessed using qualitative assessment tools, blood tests, 16S RNA sequencing on faecal samples for 12 weeks. Endoscopic and histological assessments were also performed at baseline and week 12. The paired primary endpoints were remission of UC and successful engraftment of donor faecal microbiota at 12 weeks. Clinical remission was defined as Mayo score ≤ 2 with an endoscopic Mayo score of 0.Conclusions Eighteen patients were recruited between July 2016 and February 2020 and five achieved clinical remission. Clinical remission was more frequently observed among subjects with mild-moderate disease (P = 0.173). No correlations between FMT dose, frequency and clinical response were observed. The 16S evaluation demonstrated the altering the faecal microbiota after the interventions. This study also showed an inverse correlation between IL-10 and the severity of UC. The narrative review highlighted the importance of urgent universal consensus on both clinical remission and validated outcome tools, such as the UCEIS. This feasibility study of FMT successfully demonstrated potential for employing this method in the management of UC. E-Thesis Swansea Faecal Microbiota Transplant, FMT, Ulcerative Colitis, FMTUC 18 10 2022 2022-10-18 10.23889/SUthesis.61587 COLLEGE NANME COLLEGE CODE Swansea University Davies, Angharad ; Row, Paula Doctoral M.D Swansea Bay University Health Board 2022-10-19T16:47:57.8293036 2022-10-19T10:11:03.7370789 Faculty of Medicine, Health and Life Sciences Swansea University Medical School - Medicine MAKI JITSUMURA 1 Under embargo Under embargo 2022-10-19T10:22:45.3438814 Output 9297331 application/pdf E-Thesis – open access true 2025-10-18T00:00:00.0000000 Copyright: The author, Dr. Maki Jitsumura, 2022. true eng
title Faecal Microbiota Transplant in Ulcerative Colitis (FMTUC) A Randomised Clinical Trial Feasibility Study
spellingShingle Faecal Microbiota Transplant in Ulcerative Colitis (FMTUC) A Randomised Clinical Trial Feasibility Study
MAKI JITSUMURA
title_short Faecal Microbiota Transplant in Ulcerative Colitis (FMTUC) A Randomised Clinical Trial Feasibility Study
title_full Faecal Microbiota Transplant in Ulcerative Colitis (FMTUC) A Randomised Clinical Trial Feasibility Study
title_fullStr Faecal Microbiota Transplant in Ulcerative Colitis (FMTUC) A Randomised Clinical Trial Feasibility Study
title_full_unstemmed Faecal Microbiota Transplant in Ulcerative Colitis (FMTUC) A Randomised Clinical Trial Feasibility Study
title_sort Faecal Microbiota Transplant in Ulcerative Colitis (FMTUC) A Randomised Clinical Trial Feasibility Study
author_id_str_mv e593989d2824903a0be32c3d7b7012aa
author_id_fullname_str_mv e593989d2824903a0be32c3d7b7012aa_***_MAKI JITSUMURA
author MAKI JITSUMURA
author2 MAKI JITSUMURA
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publishDate 2022
institution Swansea University
doi_str_mv 10.23889/SUthesis.61587
college_str Faculty of Medicine, Health and Life Sciences
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hierarchy_top_id facultyofmedicinehealthandlifesciences
hierarchy_top_title Faculty of Medicine, Health and Life Sciences
hierarchy_parent_id facultyofmedicinehealthandlifesciences
hierarchy_parent_title Faculty of Medicine, Health and Life Sciences
department_str Swansea University Medical School - Medicine{{{_:::_}}}Faculty of Medicine, Health and Life Sciences{{{_:::_}}}Swansea University Medical School - Medicine
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description Aims Restoring gut dysbiosis with faecal microbiota transplant (FMT) is of increasing interest as a therapeutic option in the management of Ulcerative colitis (UC). The aims of this thesis are to conduct a review of endpoints in UC clinical trials, to conduct a Phase II feasibility study to estimate the magnitude of treatment response to FMT in treatment-naïve patients with UC, to evaluate recruitment rates and to determine optimal study conditions and choice of endpoints for the phase III FMTUC study. Methods Narrative Review: The current consensus on endpoints in UC clinical trials were systematically reviewed using two indices: the Ulcerative Colitis Endoscopic Index of Severity (UCEIS) and the Ulcerative Colitis Disease Activity Index (UCDAI). FMTUC: Treatment-naive UC subjects were randomised to i) single enema, ii) five daily enemas or iii) control group. All groups received bowel decontamination prior to the FMT interventions. Subjects were assessed using qualitative assessment tools, blood tests, 16S RNA sequencing on faecal samples for 12 weeks. Endoscopic and histological assessments were also performed at baseline and week 12. The paired primary endpoints were remission of UC and successful engraftment of donor faecal microbiota at 12 weeks. Clinical remission was defined as Mayo score ≤ 2 with an endoscopic Mayo score of 0.Conclusions Eighteen patients were recruited between July 2016 and February 2020 and five achieved clinical remission. Clinical remission was more frequently observed among subjects with mild-moderate disease (P = 0.173). No correlations between FMT dose, frequency and clinical response were observed. The 16S evaluation demonstrated the altering the faecal microbiota after the interventions. This study also showed an inverse correlation between IL-10 and the severity of UC. The narrative review highlighted the importance of urgent universal consensus on both clinical remission and validated outcome tools, such as the UCEIS. This feasibility study of FMT successfully demonstrated potential for employing this method in the management of UC.
published_date 2022-10-18T04:20:31Z
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