Comparison of the efficacy and tolerability of elobixibat plus sodium picosulfate with magnesium citrate and split-dose 2-L polyethylene glycol with ascorbic acid for bowel preparation before outpatient colonoscopy: a study protocol for the multicentre, randomised, controlled E-PLUS trial
Abstract Background Sodium picosulfate (SP)/magnesium citrate (MC) and polyethylene glycol (PEG) plus ascorbic acid are recommended by Western guidelines as laxative solutions for bowel preparation. Clinically, SP/MC has a slower post-dose defaecation response than PEG and is perceived as less clean...
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| Format: | Article |
| Language: | English |
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BMC
2024-02-01
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| Series: | BMC Gastroenterology |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s12876-024-03146-6 |
| _version_ | 1797274464416694272 |
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| author | Kinichi Hotta Yosuke Otake Daisuke Yamaguchi Yuichi Shimodate Norihiro Hanabata Hiroaki Ikematsu Yohei Yabuuchi Yasushi Sano Ryo Shimoda Shinya Sugimoto Mari Oba Hiroyuki Takamaru Kouichiro Kimura Yoshihiro Kishida Kazunori Takada Sayo Ito Kenichiro Imai Kazuya Hosotani Tatsuro Murano Masayoshi Yamada Kensuke Shinmura Rio Takezawa Michito Tomonaga Yutaka Saito |
| author_facet | Kinichi Hotta Yosuke Otake Daisuke Yamaguchi Yuichi Shimodate Norihiro Hanabata Hiroaki Ikematsu Yohei Yabuuchi Yasushi Sano Ryo Shimoda Shinya Sugimoto Mari Oba Hiroyuki Takamaru Kouichiro Kimura Yoshihiro Kishida Kazunori Takada Sayo Ito Kenichiro Imai Kazuya Hosotani Tatsuro Murano Masayoshi Yamada Kensuke Shinmura Rio Takezawa Michito Tomonaga Yutaka Saito |
| author_sort | Kinichi Hotta |
| collection | DOAJ |
| description | Abstract Background Sodium picosulfate (SP)/magnesium citrate (MC) and polyethylene glycol (PEG) plus ascorbic acid are recommended by Western guidelines as laxative solutions for bowel preparation. Clinically, SP/MC has a slower post-dose defaecation response than PEG and is perceived as less cleansing; therefore, it is not currently used for major bowel cancer screening preparation. The standard formulation for bowel preparation is PEG; however, a large dose is required, and it has a distinctive flavour that is considered unpleasant. SP/MC requires a small dose and ensures fluid intake because it is administered in another beverage. Therefore, clinical trials have shown that SP/MC is superior to PEG in terms of acceptability. We aim to compare the novel bowel cleansing method (test group) comprising SP/MC with elobixibat hydrate and the standard bowel cleansing method comprising PEG plus ascorbic acid (standard group) for patients preparing for outpatient colonoscopy. Methods This phase III, multicentre, single-blind, noninferiority, randomised, controlled, trial has not yet been completed. Patients aged 40–69 years will be included as participants. Patients with a history of abdominal or pelvic surgery, constipation, inflammatory bowel disease, or severe organ dysfunction will be excluded. The target number of research participants is 540 (standard group, 270 cases; test group, 270 cases). The primary endpoint is the degree of bowel cleansing (Boston Bowel Preparation Scale [BBPS] score ≥ 6). The secondary endpoints are patient acceptability, adverse events, polyp/adenoma detection rate, number of polyps/adenomas detected, degree of bowel cleansing according to the BBPS (BBPS score ≥ 8), degree of bowel cleansing according to the Aronchik scale, and bowel cleansing time. Discussion This trial aims to develop a “patient-first” colon cleansing regimen without the risk of inadequate bowel preparation by using both elobixibat hydrate and SP/MC. Trial registration Japan Registry of Clinical Trials (jRCT; no. s041210067; 9 September 2021; https://jrct.niph.go.jp/ ), protocol version 1.5 (May 1, 2023). |
| first_indexed | 2024-03-07T14:58:45Z |
| format | Article |
| id | doaj.art-b6aa99c81a754e39a343a9e2a107fdfc |
| institution | Directory Open Access Journal |
| issn | 1471-230X |
| language | English |
| last_indexed | 2024-03-07T14:58:45Z |
| publishDate | 2024-02-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Gastroenterology |
| spelling | doaj.art-b6aa99c81a754e39a343a9e2a107fdfc2024-03-05T19:17:53ZengBMCBMC Gastroenterology1471-230X2024-02-0124111010.1186/s12876-024-03146-6Comparison of the efficacy and tolerability of elobixibat plus sodium picosulfate with magnesium citrate and split-dose 2-L polyethylene glycol with ascorbic acid for bowel preparation before outpatient colonoscopy: a study protocol for the multicentre, randomised, controlled E-PLUS trialKinichi Hotta0Yosuke Otake1Daisuke Yamaguchi2Yuichi Shimodate3Norihiro Hanabata4Hiroaki Ikematsu5Yohei Yabuuchi6Yasushi Sano7Ryo Shimoda8Shinya Sugimoto9Mari Oba10Hiroyuki Takamaru11Kouichiro Kimura12Yoshihiro Kishida13Kazunori Takada14Sayo Ito15Kenichiro Imai16Kazuya Hosotani17Tatsuro Murano18Masayoshi Yamada19Kensuke Shinmura20Rio Takezawa21Michito Tomonaga22Yutaka Saito23Division of Endoscopy, Shizuoka Cancer CenterDepartment of Gastroenterology, Subaru Health Insurance Society Ota Memorial HospitalDepartment of Gastroenterology, National Hospital Organization Ureshino Medical CenterDepartment of Gastroenterology and Hepatology, Kurashiki Central HospitalDepartment of Gastroenterology, Aomori Prefectural Central HospitalEndoscopy Division, National Cancer Center Hospital EastDepartment of Gastroenterology, Kobe City Medical Center General HospitalGastrointestinal Center, Sano HospitalDepartment of Internal Medicine, Division of Gastroenterology, Faculty of Medicine, Saga UniversityDepartment of Gastroenterology, Japanese Red Cross Ise HospitalNational Center of Neurology and PsychiatryEndoscopy Division, National Cancer Center HospitalDepartment of Gastroenterology, Subaru Health Insurance Society Ota Memorial HospitalDivision of Endoscopy, Shizuoka Cancer CenterDivision of Endoscopy, Shizuoka Cancer CenterDivision of Endoscopy, Shizuoka Cancer CenterDivision of Endoscopy, Shizuoka Cancer CenterDepartment of Gastroenterology, Kobe City Medical Center General HospitalEndoscopy Division, National Cancer Center Hospital EastEndoscopy Division, National Cancer Center HospitalEndoscopy Division, National Cancer Center Hospital EastDepartment of Gastroenterology and Hepatology, Kurashiki Central HospitalDepartment of Internal Medicine, Division of Gastroenterology, Faculty of Medicine, Saga UniversityEndoscopy Division, National Cancer Center HospitalAbstract Background Sodium picosulfate (SP)/magnesium citrate (MC) and polyethylene glycol (PEG) plus ascorbic acid are recommended by Western guidelines as laxative solutions for bowel preparation. Clinically, SP/MC has a slower post-dose defaecation response than PEG and is perceived as less cleansing; therefore, it is not currently used for major bowel cancer screening preparation. The standard formulation for bowel preparation is PEG; however, a large dose is required, and it has a distinctive flavour that is considered unpleasant. SP/MC requires a small dose and ensures fluid intake because it is administered in another beverage. Therefore, clinical trials have shown that SP/MC is superior to PEG in terms of acceptability. We aim to compare the novel bowel cleansing method (test group) comprising SP/MC with elobixibat hydrate and the standard bowel cleansing method comprising PEG plus ascorbic acid (standard group) for patients preparing for outpatient colonoscopy. Methods This phase III, multicentre, single-blind, noninferiority, randomised, controlled, trial has not yet been completed. Patients aged 40–69 years will be included as participants. Patients with a history of abdominal or pelvic surgery, constipation, inflammatory bowel disease, or severe organ dysfunction will be excluded. The target number of research participants is 540 (standard group, 270 cases; test group, 270 cases). The primary endpoint is the degree of bowel cleansing (Boston Bowel Preparation Scale [BBPS] score ≥ 6). The secondary endpoints are patient acceptability, adverse events, polyp/adenoma detection rate, number of polyps/adenomas detected, degree of bowel cleansing according to the BBPS (BBPS score ≥ 8), degree of bowel cleansing according to the Aronchik scale, and bowel cleansing time. Discussion This trial aims to develop a “patient-first” colon cleansing regimen without the risk of inadequate bowel preparation by using both elobixibat hydrate and SP/MC. Trial registration Japan Registry of Clinical Trials (jRCT; no. s041210067; 9 September 2021; https://jrct.niph.go.jp/ ), protocol version 1.5 (May 1, 2023).https://doi.org/10.1186/s12876-024-03146-6Boston bowel preparation scaleBowel preparationColonoscopyElobixibatPolyethylene glycolSodium picosulfate magnesium citrate |
| spellingShingle | Kinichi Hotta Yosuke Otake Daisuke Yamaguchi Yuichi Shimodate Norihiro Hanabata Hiroaki Ikematsu Yohei Yabuuchi Yasushi Sano Ryo Shimoda Shinya Sugimoto Mari Oba Hiroyuki Takamaru Kouichiro Kimura Yoshihiro Kishida Kazunori Takada Sayo Ito Kenichiro Imai Kazuya Hosotani Tatsuro Murano Masayoshi Yamada Kensuke Shinmura Rio Takezawa Michito Tomonaga Yutaka Saito Comparison of the efficacy and tolerability of elobixibat plus sodium picosulfate with magnesium citrate and split-dose 2-L polyethylene glycol with ascorbic acid for bowel preparation before outpatient colonoscopy: a study protocol for the multicentre, randomised, controlled E-PLUS trial BMC Gastroenterology Boston bowel preparation scale Bowel preparation Colonoscopy Elobixibat Polyethylene glycol Sodium picosulfate magnesium citrate |
| title | Comparison of the efficacy and tolerability of elobixibat plus sodium picosulfate with magnesium citrate and split-dose 2-L polyethylene glycol with ascorbic acid for bowel preparation before outpatient colonoscopy: a study protocol for the multicentre, randomised, controlled E-PLUS trial |
| title_full | Comparison of the efficacy and tolerability of elobixibat plus sodium picosulfate with magnesium citrate and split-dose 2-L polyethylene glycol with ascorbic acid for bowel preparation before outpatient colonoscopy: a study protocol for the multicentre, randomised, controlled E-PLUS trial |
| title_fullStr | Comparison of the efficacy and tolerability of elobixibat plus sodium picosulfate with magnesium citrate and split-dose 2-L polyethylene glycol with ascorbic acid for bowel preparation before outpatient colonoscopy: a study protocol for the multicentre, randomised, controlled E-PLUS trial |
| title_full_unstemmed | Comparison of the efficacy and tolerability of elobixibat plus sodium picosulfate with magnesium citrate and split-dose 2-L polyethylene glycol with ascorbic acid for bowel preparation before outpatient colonoscopy: a study protocol for the multicentre, randomised, controlled E-PLUS trial |
| title_short | Comparison of the efficacy and tolerability of elobixibat plus sodium picosulfate with magnesium citrate and split-dose 2-L polyethylene glycol with ascorbic acid for bowel preparation before outpatient colonoscopy: a study protocol for the multicentre, randomised, controlled E-PLUS trial |
| title_sort | comparison of the efficacy and tolerability of elobixibat plus sodium picosulfate with magnesium citrate and split dose 2 l polyethylene glycol with ascorbic acid for bowel preparation before outpatient colonoscopy a study protocol for the multicentre randomised controlled e plus trial |
| topic | Boston bowel preparation scale Bowel preparation Colonoscopy Elobixibat Polyethylene glycol Sodium picosulfate magnesium citrate |
| url | https://doi.org/10.1186/s12876-024-03146-6 |
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