Back to resultsEfficacy of a Low Fiber Diet for Pediatric Colonoscopy Prep
Primary Purpose
Colitis, Gastrointestinal Diseases, Pediatric Disorder
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low fiber diet
Standard clear liquid diet
Sponsored by
About this trial
This is an interventional treatment trial for Colitis
Eligibility Criteria
Inclusion Criteria: - All outpatients undergoing colonoscopy at our institution Exclusion Criteria: Unstable medical condition Metabolic disease Inpatient status Requiring an emergency colonoscopy
Sites / Locations
- Rhode Island Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Low fiber diet group
Clear liquid diet group
Arm Description
Subjects are allowed a low fiber diet the day of their colonoscopy prep
Subjects are allowed a clear liquid diet the day of their colonoscopy prep, as is standard of care
Outcomes
Primary Outcome Measures
Boston Bowel Prep Score
Scale from 0 - 3 (0 = Unprepared segment colon; 3 = well-visualized segment of colon)
Secondary Outcome Measures
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05918562
Brief Title
Efficacy of a Low Fiber Diet for Pediatric Colonoscopy Prep
Official Title
Efficacy of a Low Fiber Diet for Pediatric Colonoscopy Prep
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
April 20, 2021 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
September 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rhode Island Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colitis, Gastrointestinal Diseases, Pediatric Disorder, Pediatric Crohns Disease, Procedural Sequelae
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Low fiber diet group
Arm Type
Experimental
Arm Description
Subjects are allowed a low fiber diet the day of their colonoscopy prep
Arm Title
Clear liquid diet group
Arm Type
Active Comparator
Arm Description
Subjects are allowed a clear liquid diet the day of their colonoscopy prep, as is standard of care
Intervention Type
Dietary Supplement
Intervention Name(s)
Low fiber diet
Other Intervention Name(s)
Experimental group
Intervention Description
Low fiber diet including cereal, white bread, eggs, meat, dairy
Intervention Type
Dietary Supplement
Intervention Name(s)
Standard clear liquid diet
Other Intervention Name(s)
Standard group
Intervention Description
Standard clear liquid diet including broth, jello, water, juice
Primary Outcome Measure Information:
Title
Boston Bowel Prep Score
Description
Scale from 0 - 3 (0 = Unprepared segment colon; 3 = well-visualized segment of colon)
Time Frame
immediately after the colonoscopy
Secondary Outcome Measure Information:
Title
Patient tolerance
Description
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)
Time Frame
immediately before the colonoscopy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- All outpatients undergoing colonoscopy at our institution
Exclusion Criteria:
Unstable medical condition
Metabolic disease
Inpatient status
Requiring an emergency colonoscopy
Facility Information:
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy of a Low Fiber Diet for Pediatric Colonoscopy Prep
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