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A Multicenter Randomized Controlled Trial Evaluating the Efficacy of Elobixibat Hydrate in Preparing Patients with Chronic Constipation for Colonoscopy

Evaluating the Efficacy of Elobixibat Hydrate in Preparing Patients with Chronic Constipation for Colonoscopy

Oka Shiro

Hiroshima University Hospital

Kasumi 1-2-3 Minami-ku, Hiroshima

oka4683@hiroshima-u.ac.jp

Takasago Takeshi

Hiroshima University Hospital

Kasumi 1-2-3 Minami-ku, Hiroshima

+81-82-257-5190

takasago@hiroshima-u.ac.jp

Recruiting

April. 06, 2026

Interventional

randomized controlled trial

open(masking not used)

no treatment control/standard of care control

parallel assignment

treatment purpose

1) Patients scheduled to undergo colonoscopy
2) Patients aged 18 years or older at the time of consent acquisition
3) Individuals for whom written informed consent for participation in this study can be obtained
4) Patients diagnosed by a physician with chronic constipation who meet two or more items of the ROMA-IV criteria for constipation and are in a chronic state

1) Patients already taking Goofice
2) Patients with suspected gastrointestinal obstruction or intestinal obstruction
3) Patients with suspected intestinal perforation, gastric stasis, or toxic megacolon
4) Patients with inflammatory bowel disease
5) Patients who have undergone ileocecal resection or total colectomy
6) Women who are pregnant or may be pregnant, women who are breastfeeding, or women who wish to become pregnant
7) Patients with a history of hypersensitivity to Goofice, picosulfate sodium, or any component of Moviprep
8) Other patients deemed ineligible for enrollment in this study by the principal investigator or sub-investigator

Both

chronic constipation

The study group will take Goofice 10 mg/day starting 3 days prior to colonoscopy. The control group will not take Goofice.
Both groups will take picosulfate sodium the night before. Subsequently, on the day of colonoscopy, both groups will take Moviprep. The examination and various assessments will be performed on that day, concluding the study evaluation period.

Total volume of Moviprep and water consumed until completion of bowel preparation

Quality of bowel preparation
Evaluation of bowel movements during the 3 days prior to the procedure and on the morning of the procedure
Time required for bowel preparation and assessment of acceptability of Moviprep
Evaluation of adverse events during the study period

+81-82-257-1551

Feb. 20, 2026

Yes

The principal investigator or co-investigator at each participating institution shall promptly prepare a case report form after collecting the specified test items and evaluation items. The case report form shall be created using EDC, aggregating information without including any personally identifiable information. This aggregated information shall be submitted to Hiroshima University Hospital and handled with due regard for data reliability and personal information protection. The principal investigator or co-investigator at each participating institution shall appropriately store necessary records and other materials to ensure the reliability of the data, including source documents. Furthermore, information collected via questionnaires and other detailed information shall be managed appropriately using paper reports, in the same manner as EDC information.

none