Efficacy of a Low Fiber Diet for Pediatric Colonoscopy Prep

NCT ID: NCT05918562

Last Updated: 2023-06-26

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-20

Study Completion Date

2023-09-01

Brief Summary

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This study is designed to evaluate if pediatric patients who are undergoing a bowel preparation in anticipation of a colonoscopy may be able to take in a low fiber diet instead of a standard, clear liquid diet, while still accomplishing an adequate bowel prep.

Detailed Description

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Conditions

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Colitis Gastrointestinal Diseases Pediatric Disorder Pediatric Crohns Disease Procedural Sequelae

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Investigators

Study Groups

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Low fiber diet group

Subjects are allowed a low fiber diet the day of their colonoscopy prep

Group Type EXPERIMENTAL

Low fiber diet

Intervention Type DIETARY_SUPPLEMENT

Low fiber diet including cereal, white bread, eggs, meat, dairy

Clear liquid diet group

Subjects are allowed a clear liquid diet the day of their colonoscopy prep, as is standard of care

Group Type ACTIVE_COMPARATOR

Standard clear liquid diet

Intervention Type DIETARY_SUPPLEMENT

Standard clear liquid diet including broth, jello, water, juice

Interventions

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Low fiber diet

Low fiber diet including cereal, white bread, eggs, meat, dairy

Intervention Type DIETARY_SUPPLEMENT

Standard clear liquid diet

Standard clear liquid diet including broth, jello, water, juice

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Experimental group Standard group

Eligibility Criteria

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Inclusion Criteria

\- All outpatients undergoing colonoscopy at our institution

Exclusion Criteria

* Unstable medical condition
* Metabolic disease
* Inpatient status
* Requiring an emergency colonoscopy
Minimum Eligible Age

10 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rhode Island Hospital

OTHER

Sponsor Role lead

Responsible Party

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Michael Herzlinger

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Rhode Island Hospital

Providence, Rhode Island, United States

Site Status

Countries

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United States

Other Identifiers

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1640783-12

Identifier Type: -

Identifier Source: org_study_id

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