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NCT05918562 Clinical Trial

Efficacy of a Low Fiber Diet for Pediatric Colonoscopy Prep

Gastrointestinal Diseases Clinical Trial

Official title:
Efficacy of a Low Fiber Diet for Pediatric Colonoscopy Prep

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT05918562
Other study ID # 1640783-12
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date April 20, 2021
Est. completion date September 1, 2023

Study information
Verified date June 2023
Source Rhode Island Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 80
Est. completion date September 1, 2023
Est. primary completion date September 1, 2023
Accepts healthy volunteers No
Gender All
Age group 10 Years to 17 Years
Eligibility Inclusion Criteria: - All outpatients undergoing colonoscopy at our institution Exclusion Criteria: - Unstable medical condition - Metabolic disease - Inpatient status - Requiring an emergency colonoscopy

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Low fiber diet
Low fiber diet including cereal, white bread, eggs, meat, dairy
• Standard clear liquid diet
Standard clear liquid diet including broth, jello, water, juice

Locations
Country Name City State
United States Rhode Island Hospital Providence Rhode Island

Sponsors (1)
Lead Sponsor Collaborator
Rhode Island Hospital

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Boston Bowel Prep Score Scale from 0 - 3 (0 = Unprepared segment colon; 3 = well-visualized segment of colon) immediately after the colonoscopy
Secondary Patient tolerance 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) immediately before the colonoscopy
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