Pediatric Disorder Clinical Trial
Official title:
Evaluation of Short Peptide Formula for Bowel Preparation in Video Capsule Endoscopy
Verified date | February 2020 |
Source | Children's Hospital of Fudan University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Video capsule endoscopy (VCE) is a noninvasive diagnostic tool used to assess the small bowel pathology. The diagnostic value of VCE is mostly dependent on the cleanliness of the colon. Investigators are aimed to prospectively assess the quality of bowel preparation in pediatric patients receiving short peptide diet versus those receiving liquid diet.
Status | Completed |
Enrollment | 210 |
Est. completion date | December 31, 2019 |
Est. primary completion date | December 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Years to 18 Years |
Eligibility |
Inclusion Criteria: - Indications of capsule endoscopy; - Informed consent form obtained. Exclusion Criteria: - Contraindication of capsule endoscopy; - Unwilling to participate; - Formula allergy; - Unable to swallow the capsule. |
Country | Name | City | State |
---|---|---|---|
China | Children's hospital of Fudan university | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital of Fudan University |
China,
Goyal J, Goel A, McGwin G, Weber F. Analysis of a grading system to assess the quality of small-bowel preparation for capsule endoscopy: in search of the Holy Grail. Endosc Int Open. 2014 Sep;2(3):E183-6. doi: 10.1055/s-0034-1377521. Epub 2014 Jul 16. — View Citation
van Tuyl SA, den Ouden H, Stolk MF, Kuipers EJ. Optimal preparation for video capsule endoscopy: a prospective, randomized, single-blind study. Endoscopy. 2007 Dec;39(12):1037-40. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Adverse events | Adverse events | assessed through study completion, an average of 1 year | |
Other | Bristol scores | average Bristol scores during bowel preparation | assessed through study completion, an average of 1 year | |
Primary | Cleansing score | Cleansing scores were recorded according to a predetermined criterion | assessed through study completion, an average of 1 year | |
Secondary | Diagnostic yield | Percentage of positive cases | assessed through study completion, an average of 1 year | |
Secondary | Completion rate | CE was considered complete when the cecum was reached within recording time | assessed through study completion, an average of 1 year |
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