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Short Peptide Formula for Bowel Preparation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03742934
Recruitment Status : Completed
First Posted : November 15, 2018
Last Update Posted : February 17, 2020
Sponsor:
Information provided by (Responsible Party):
Ying HUANG, 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.

Condition or disease Intervention/treatment Phase
Capsule Endoscopy Pediatric Disorder Other: Short peptide Other: Liquid diet Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Evaluation of Short Peptide Formula for Bowel Preparation in Video Capsule Endoscopy
Actual Study Start Date : January 1, 2019
Actual Primary Completion Date : December 31, 2019
Actual Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arm Intervention/treatment
Experimental: Formula group
short peptide formula prior to capsule endoscopy
Other: Short peptide
Short peptide formula during bowel preparation

Control group
regular liquid diet
Other: Liquid diet
Liquid diet during bowel preparation




Primary Outcome Measures :
  1. Cleansing score [ Time Frame: assessed through study completion, an average of 1 year ]
    Cleansing scores were recorded according to a predetermined criterion


Secondary Outcome Measures :
  1. Diagnostic yield [ Time Frame: assessed through study completion, an average of 1 year ]
    Percentage of positive cases

  2. 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


Other Outcome Measures:
  1. Adverse events [ Time Frame: assessed through study completion, an average of 1 year ]
    Adverse events

  2. Bristol scores [ Time Frame: assessed through study completion, an average of 1 year ]
    average Bristol scores during bowel preparation



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03742934


Locations
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China, Shanghai
Children's hospital of Fudan university
Shanghai, Shanghai, China, 201102
Sponsors and Collaborators
Children's Hospital of Fudan University
Investigators
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Study Director: Ying Huang, PhD Children's Hospital of Fudan University
Publications:
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Responsible Party: Ying HUANG, The director of gastroenterology of Children's Hospital of Fudan University, Children's Hospital of Fudan University
ClinicalTrials.gov Identifier: NCT03742934    
Other Study ID Numbers: PreparationVCE
First Posted: November 15, 2018    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ying HUANG, Children's Hospital of Fudan University:
Bowel preparation