Short Peptide Formula for Bowel Preparation

NCT ID: NCT03742934

Last Updated: 2020-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2019-12-31

Brief Summary

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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

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Conditions

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Capsule Endoscopy Pediatric Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Formula group

short peptide formula prior to capsule endoscopy

Group Type EXPERIMENTAL

Short peptide

Intervention Type OTHER

Short peptide formula during bowel preparation

Control group

regular liquid diet

Group Type OTHER

Liquid diet

Intervention Type OTHER

Liquid diet during bowel preparation

Interventions

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Short peptide

Short peptide formula during bowel preparation

Intervention Type OTHER

Liquid diet

Liquid diet during bowel preparation

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

3 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Hospital of Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Ying HUANG

The director of gastroenterology of Children's Hospital of Fudan University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ying Huang, PhD

Role: STUDY_DIRECTOR

Children's Hospital of Fudan University

Locations

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Children's hospital of Fudan university

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 26134966 (View on PubMed)

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. doi: 10.1055/s-2007-966988.

Reference Type BACKGROUND
PMID: 18072052 (View on PubMed)

Other Identifiers

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PreparationVCE

Identifier Type: -

Identifier Source: org_study_id

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