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JAPANESE
JRCT ID: jRCTs051250181

Registered date:07/01/2026

Pilot Study on the Effect of PicoPrep as a Bowel Preparation on Visualization Quality in Small Bowel Capsule Endoscopy.

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedPatients indicated for small bowel capsule endoscopy for diagnostic evaluation
Date of first enrollment07/01/2026
Target sample size30
Countries of recruitment
Study typeInterventional
Intervention(s)Patients receiving PicoPrep as a bowel preparation regimen before undergoing capsule endoscopy

Outcome(s)

Primary OutcomeImage Quality Score of the Small Bowel Mucosa
Secondary OutcomeDetection of pathological findings (bleeding, ulcerations, or vascular abnormalities) Evaluation of adequacy of bowel cleansing(whether an image quality score of 2.25 or higher was achieved) Completion of small bowel capsule endoscopy to the cecum within the recording time Measurement of small bowel transit time

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximumNot applicable
GenderBoth
Include criteria1. Patients undergoing small bowel capsule endoscopy 2. Aged 18 years or older at the time of obtaining informed consent 3. Able to take oral laxatives 4. Patients who have provided written informed consent of their own free will to participate in this clinical study
Exclude criteria1. Patients with severe renal impairment (eGFR < 30 mL/min/1.73 m2). 2. Patients with severe heart failure (NYHA Class III or IV). 3. Patients with hyponatremia (serum sodium < 136 mEq/L) or hypokalemia (serum potassium < 3.5 mEq/L). 4. Patients with a history of surgical resection of the gastrointestinal tract (excluding appendectomy). 5. Patients who show evidence of impaired gastrointestinal passage on transit studies, or who are suspected of having intestinal obstruction or perforation. 6. Patients with toxic megacolon. 7. Patients suspected of having an acute abdomen. 8. Patients with a history of hypersensitivity to any component of PicoPrep. 9. Patients receiving iron supplementation who, for clinical reasons, are unable to comply with the discontinuation required in this study (cessation at least 7 days before examination). 10. Any other patients deemed inappropriate for inclusion in this clinical study by the investigator.

Related Information

Contact

Public contact
Name Norihiro Okamoto
Address 7-5-2,Kusunoki-cho,Chuo-ku,Kobe,Hyogo Hyogo Japan 650-0017
Telephone +81-78-382-6305
E-mail nokmt@med.kobe-u.ac.jp
Affiliation Kobe University Hospital
Scientific contact
Name Daisuke Watanabe
Address 7-5-2,Kusunoki-cho,Chuo-ku,Kobe,Hyogo Hyogo Japan 650-0017
Telephone +81-78-382-6305
E-mail daisuke@med.kobe-u.ac.jp
Affiliation Kobe University Hospital