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Efficacy of a Low Fiber Diet for Pediatric Colonoscopy Prep

Sponsor
Rhode Island Hospital (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05918562
Collaborator
(none)
80
Enrollment
1
Location
2
Arms
28.4
Anticipated Duration (Months)
2.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Low fiber diet
  • Dietary Supplement: Standard clear liquid diet
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Efficacy of a Low Fiber Diet for Pediatric Colonoscopy Prep
Actual Study Start Date :
Apr 20, 2021
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Low fiber diet group

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

Dietary Supplement: Low fiber diet
Low fiber diet including cereal, white bread, eggs, meat, dairy
Other Names:
  • Experimental group

    		•
    Active Comparator: Clear liquid diet group

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

    Dietary Supplement: Standard clear liquid diet
    Standard clear liquid diet including broth, jello, water, juice
    Other Names:
  • Standard group

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Boston Bowel Prep Score [immediately after the colonoscopy]

      Scale from 0 - 3 (0 = Unprepared segment colon; 3 = well-visualized segment of colon)

    Secondary Outcome Measures

    1. Patient tolerance [immediately before the colonoscopy]

      Internally developed questionnaire inquiring patients about their experience with their prep including likert scale measures of hunger, fullness, nausea, stress, and ease of compliance to regimen)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    10 Years to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • All outpatients undergoing colonoscopy at our institution
    Exclusion Criteria:

    • Unstable medical condition

    • Metabolic disease

    • Inpatient status

    • Requiring an emergency colonoscopy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Rhode Island Hospital Providence Rhode Island United States 02903

    Sponsors and Collaborators

    • Rhode Island Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Michael Herzlinger, MD, Rhode Island Hospital
    ClinicalTrials.gov Identifier:
    NCT05918562
    Other Study ID Numbers:
    • 1640783-12
    First Posted:
    Jun 26, 2023
    Last Update Posted:
    Jun 26, 2023
    Last Verified:
    Jun 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Crohn Disease
    Gastrointestinal Diseases
    Digestive System Diseases

    Study Results

    No Results Posted as of Jun 26, 2023