Short Peptide Formula for Bowel Preparation

Pediatric Disorder Clinical Trial

Official title:

Evaluation of Short Peptide Formula for Bowel Preparation in Video Capsule Endoscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03742934
• Other study ID #: PreparationVCE
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: February 2020
• Source: Children's Hospital of Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Capsule Endoscopy
• Pediatric Disorder

Intervention

Other:
• Short peptide
Short peptide formula during bowel preparation
• Liquid diet
Liquid diet during bowel preparation

Locations

Country	Name	City	State
China	Children's hospital of Fudan university	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Fudan University

Country where clinical trial is conducted

China, 

References & Publications (2)

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

Outcome

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