Rationale and design of a multicenter, single-group, open-label trial aiming at investigating the effectiveness of elobixibat for loss of defecation desire in patients with chronic constipation
Background: Approximately 60% of patients with chronic constipation (CC) have a significantly higher rate of loss of defecation desire (LODD). Bile acids are expected to have a restorative effect on defecation desire (DD) because they lower the rectal sensory threshold, which is an objective index o...
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Elsevier
2022-08-01
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| Series: | Contemporary Clinical Trials Communications |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2451865422000758 |
| _version_ | 1811324287694405632 |
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| author | Atsushi Yamamoto Takaomi Kessoku Kosuke Tanaka Kota Takahashi Yuki Kasai Anna Ozaki Michihiro Iwaki Takashi Kobayashi Tsutomu Yoshihara Noboru Misawa Kanji Ohkuma Akiko Fuyuki Takuma Higurashi Kunihiro Hosono Masato Yoneda Tomoyuki Iwasaki Takeo Kurihashi Machiko Nakatogawa Ayao Suzuki Masataka Taguri Shunsuke Oyamada Keisuke Ariyoshi Noritoshi Kobayashi Yasushi Ichikawa Atsushi Nakajima |
| author_facet | Atsushi Yamamoto Takaomi Kessoku Kosuke Tanaka Kota Takahashi Yuki Kasai Anna Ozaki Michihiro Iwaki Takashi Kobayashi Tsutomu Yoshihara Noboru Misawa Kanji Ohkuma Akiko Fuyuki Takuma Higurashi Kunihiro Hosono Masato Yoneda Tomoyuki Iwasaki Takeo Kurihashi Machiko Nakatogawa Ayao Suzuki Masataka Taguri Shunsuke Oyamada Keisuke Ariyoshi Noritoshi Kobayashi Yasushi Ichikawa Atsushi Nakajima |
| author_sort | Atsushi Yamamoto |
| collection | DOAJ |
| description | Background: Approximately 60% of patients with chronic constipation (CC) have a significantly higher rate of loss of defecation desire (LODD). Bile acids are expected to have a restorative effect on defecation desire (DD) because they lower the rectal sensory threshold, which is an objective index of DD. Elobixibat (EXB) specifically inhibits the ileal bile acid transporter/apical sodium-dependent bile acid transporter, which is a transporter involved in the reabsorption of bile acids in the terminal ileum. This study aims to investigate the LODD improvement rate in patients with CC after 4 weeks of EXB treatment. Methods: A total of 40 adult patients with CC who meet the eligibility criteria will be enrolled. Patients will receive oral EXB (10 mg/day) for 4 weeks. A patient diary will be provided daily at 4 weeks after treatment. The primary endpoint will be the percentage LODD improvement at week 4 of the treatment period from week 2 of the observation period using questionnaires. Ethics and dissemination: Ethical approval was obtained from the Yokohama City University Certified Institutional Review Board prior to participant enrolment (approval number: CRB21-008). The results of this study will be submitted for publication in international peer-reviewed journals, and key findings will be presented at international scientific conferences. Participants desiring the results of this study will be directly contacted for data dissemination. Trial registration: This trial was registered at ClinicalTrials.gov (NCT05165199). Protocol version: 1.0, September 21, 2021. |
| first_indexed | 2024-04-13T14:11:40Z |
| format | Article |
| id | doaj.art-07d98197f50b47d384147d049544ecea |
| institution | Directory Open Access Journal |
| issn | 2451-8654 |
| language | English |
| last_indexed | 2024-04-13T14:11:40Z |
| publishDate | 2022-08-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Contemporary Clinical Trials Communications |
| spelling | doaj.art-07d98197f50b47d384147d049544ecea2022-12-22T02:43:45ZengElsevierContemporary Clinical Trials Communications2451-86542022-08-0128100958Rationale and design of a multicenter, single-group, open-label trial aiming at investigating the effectiveness of elobixibat for loss of defecation desire in patients with chronic constipationAtsushi Yamamoto0Takaomi Kessoku1Kosuke Tanaka2Kota Takahashi3Yuki Kasai4Anna Ozaki5Michihiro Iwaki6Takashi Kobayashi7Tsutomu Yoshihara8Noboru Misawa9Kanji Ohkuma10Akiko Fuyuki11Takuma Higurashi12Kunihiro Hosono13Masato Yoneda14Tomoyuki Iwasaki15Takeo Kurihashi16Machiko Nakatogawa17Ayao Suzuki18Masataka Taguri19Shunsuke Oyamada20Keisuke Ariyoshi21Noritoshi Kobayashi22Yasushi Ichikawa23Atsushi Nakajima24Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Japan; Department of Gastroenterology, Fujisawa Syounandai Hospital, JapanDepartment of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Japan; Department of Palliative Medicine, Yokohama City University Hospital, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan; Corresponding author. Department of Palliative Medicine, Yokohama City University Hospital, 3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004, Japan.Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Japan; Department of Palliative Medicine, Yokohama City University Hospital, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, JapanDepartment of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, JapanDepartment of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, JapanDepartment of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, JapanDepartment of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Japan; Department of Palliative Medicine, Yokohama City University Hospital, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, JapanDepartment of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, JapanDepartment of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, JapanDepartment of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, JapanDepartment of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Japan; Department of Gastroenterology, Fujisawa Syounandai Hospital, JapanDepartment of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Japan; Department of Palliative Medicine, Yokohama City University Hospital, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, JapanDepartment of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, JapanDepartment of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, JapanDepartment of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, JapanDepartment of Internal Medicine, Iwasaki Naika Clinic, JapanDepartment of Internal Medicine, Kanagawa Dental University Yokohama Clinic, JapanDepartment of Internal Medicine, NamikiKoiso Medical Clinic, JapanDepartment of Internal Medicine, NamikiKoiso Medical Clinic, JapanDepartment of Data Science, Yokohama City University Graduate School of Medicine, JapanDepartment of Biostatistics, JORTC Data Center, JapanDepartment of Biostatistics, JORTC Data Center, JapanDepartment of Oncology, Yokohama City University Hospital, Japan; Department of Oncology Yokohama City University Graduate School of Medicine, JapanDepartment of Oncology, Yokohama City University Hospital, Japan; Department of Oncology Yokohama City University Graduate School of Medicine, JapanDepartment of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, JapanBackground: Approximately 60% of patients with chronic constipation (CC) have a significantly higher rate of loss of defecation desire (LODD). Bile acids are expected to have a restorative effect on defecation desire (DD) because they lower the rectal sensory threshold, which is an objective index of DD. Elobixibat (EXB) specifically inhibits the ileal bile acid transporter/apical sodium-dependent bile acid transporter, which is a transporter involved in the reabsorption of bile acids in the terminal ileum. This study aims to investigate the LODD improvement rate in patients with CC after 4 weeks of EXB treatment. Methods: A total of 40 adult patients with CC who meet the eligibility criteria will be enrolled. Patients will receive oral EXB (10 mg/day) for 4 weeks. A patient diary will be provided daily at 4 weeks after treatment. The primary endpoint will be the percentage LODD improvement at week 4 of the treatment period from week 2 of the observation period using questionnaires. Ethics and dissemination: Ethical approval was obtained from the Yokohama City University Certified Institutional Review Board prior to participant enrolment (approval number: CRB21-008). The results of this study will be submitted for publication in international peer-reviewed journals, and key findings will be presented at international scientific conferences. Participants desiring the results of this study will be directly contacted for data dissemination. Trial registration: This trial was registered at ClinicalTrials.gov (NCT05165199). Protocol version: 1.0, September 21, 2021.http://www.sciencedirect.com/science/article/pii/S2451865422000758Chronic constipationDefecation desireElobixibatBile acidLoss of defecation desire |
| spellingShingle | Atsushi Yamamoto Takaomi Kessoku Kosuke Tanaka Kota Takahashi Yuki Kasai Anna Ozaki Michihiro Iwaki Takashi Kobayashi Tsutomu Yoshihara Noboru Misawa Kanji Ohkuma Akiko Fuyuki Takuma Higurashi Kunihiro Hosono Masato Yoneda Tomoyuki Iwasaki Takeo Kurihashi Machiko Nakatogawa Ayao Suzuki Masataka Taguri Shunsuke Oyamada Keisuke Ariyoshi Noritoshi Kobayashi Yasushi Ichikawa Atsushi Nakajima Rationale and design of a multicenter, single-group, open-label trial aiming at investigating the effectiveness of elobixibat for loss of defecation desire in patients with chronic constipation Contemporary Clinical Trials Communications Chronic constipation Defecation desire Elobixibat Bile acid Loss of defecation desire |
| title | Rationale and design of a multicenter, single-group, open-label trial aiming at investigating the effectiveness of elobixibat for loss of defecation desire in patients with chronic constipation |
| title_full | Rationale and design of a multicenter, single-group, open-label trial aiming at investigating the effectiveness of elobixibat for loss of defecation desire in patients with chronic constipation |
| title_fullStr | Rationale and design of a multicenter, single-group, open-label trial aiming at investigating the effectiveness of elobixibat for loss of defecation desire in patients with chronic constipation |
| title_full_unstemmed | Rationale and design of a multicenter, single-group, open-label trial aiming at investigating the effectiveness of elobixibat for loss of defecation desire in patients with chronic constipation |
| title_short | Rationale and design of a multicenter, single-group, open-label trial aiming at investigating the effectiveness of elobixibat for loss of defecation desire in patients with chronic constipation |
| title_sort | rationale and design of a multicenter single group open label trial aiming at investigating the effectiveness of elobixibat for loss of defecation desire in patients with chronic constipation |
| topic | Chronic constipation Defecation desire Elobixibat Bile acid Loss of defecation desire |
| url | http://www.sciencedirect.com/science/article/pii/S2451865422000758 |
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