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) studied | Patients indicated for small bowel capsule endoscopy for diagnostic evaluation |
| Date of first enrollment | 07/01/2026 |
| Target sample size | 30 |
| Countries of recruitment | |
| Study type | Interventional |
| Intervention(s) | Patients receiving PicoPrep as a bowel preparation regimen before undergoing capsule endoscopy |
Outcome(s)
| Primary Outcome | Image Quality Score of the Small Bowel Mucosa |
|---|---|
| Secondary Outcome | Detection 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 maximum | Not applicable |
| Gender | Both |
| Include criteria | 1. 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 criteria | 1. 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
| Primary Sponsor | Watanabe Daisuke |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | |
| Secondary ID(s) |
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 |
| 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 |
| daisuke@med.kobe-u.ac.jp | |
| Affiliation | Kobe University Hospital |