Short Peptide Formula for Bowel Preparation

February 13, 2020 updated by: Ying HUANG, Children's Hospital of Fudan University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

210

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 201102
        • Children's Hospital of Fudan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Formula group
short peptide formula prior to capsule endoscopy
Other: Short peptide
Short peptide formula during bowel preparation
Other: Control group
regular liquid diet
Other: Liquid diet
Liquid diet during bowel preparation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cleansing score
Time Frame: assessed through study completion, an average of 1 year
Cleansing scores were recorded according to a predetermined criterion
assessed through study completion, an average of 1 year

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: assessed through study completion, an average of 1 year
Adverse events
assessed through study completion, an average of 1 year
Bristol scores
Time Frame: assessed through study completion, an average of 1 year
average Bristol scores during bowel preparation
assessed through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital of Fudan University

Investigators

  • Study Director: Ying Huang, PhD, Children's Hospital of Fudan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Actual)

December 31, 2019

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

November 13, 2018

First Submitted That Met QC Criteria

November 14, 2018

First Posted (Actual)

November 15, 2018

Study Record Updates

Last Update Posted (Actual)

February 17, 2020

Last Update Submitted That Met QC Criteria

February 13, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PreparationVCE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pediatric Disorder

Clinical Trials on Short peptide

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Indonesia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe