NCT05918562

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 20, 2021

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

May 31, 2023

Completed
26 days until next milestone

First Posted

Study publicly available on registry

June 26, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

June 26, 2023

Status Verified

June 1, 2023

Enrollment Period

2.4 years

First QC Date

May 31, 2023

Last Update Submit

June 15, 2023

Conditions

ColitisGastrointestinal DiseasesPediatric DisorderPediatric Crohns DiseaseProcedural Sequelae

Outcome Measures

Primary Outcomes (1)

  • Boston Bowel Prep Score

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

    immediately after the colonoscopy

Secondary Outcomes (1)

  • Patient tolerance

    immediately before the colonoscopy

Study Arms (2)

Low fiber diet group

EXPERIMENTAL

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

Dietary Supplement: Low fiber diet

Clear liquid diet group

ACTIVE COMPARATOR

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

Dietary Supplement: Standard clear liquid diet

Interventions

Low fiber dietDIETARY_SUPPLEMENT

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

Also known as: Experimental group
Low fiber diet group
Standard clear liquid dietDIETARY_SUPPLEMENT

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

Also known as: Standard group
Clear liquid diet group

Eligibility Criteria

Age10 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • \- All outpatients undergoing colonoscopy at our institution

You may not qualify if:

  • Unstable medical condition
  • Metabolic disease
  • Inpatient status
  • Requiring an emergency colonoscopy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

ColitisGastrointestinal Diseases

Condition Hierarchy (Ancestors)

GastroenteritisDigestive System DiseasesColonic DiseasesIntestinal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 31, 2023

First Posted

June 26, 2023

Study Start

April 20, 2021

Primary Completion

September 1, 2023

Study Completion

September 1, 2023

Last Updated

June 26, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)