Short Peptide Formula for Bowel Preparation

Not Applicable

Completed

• Conditions: Capsule Endoscopy; Pediatric Disorder
• Interventions: Other: Short peptide; Other: Liquid diet

• Registration Number: NCT03742934
• Lead Sponsor: Children's Hospital of Fudan University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-11-13
• Study First Submitted QC: 2018-11-14
• Study First Posted: 2018-11-15
• Study Start: 2019-01-01
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-13
• Last Update Posted: 2020-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 210

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Formula group	Short peptide	short peptide formula prior to capsule endoscopy
Control group	Liquid diet	regular liquid diet

Primary Outcome Measures

Name	Time	Method
Cleansing score	assessed through study completion, an average of 1 year	Cleansing scores were recorded according to a predetermined criterion

Secondary Outcome Measures

Name	Time	Method
Completion rate	assessed through study completion, an average of 1 year	CE was considered complete when the cecum was reached within recording time
Diagnostic yield	assessed through study completion, an average of 1 year	Percentage of positive cases

Trial Locations

Locations (1)

Children's hospital of Fudan university; 🇨🇳 Shanghai, Shanghai, China