ColitisNCT05918562
Efficacy of a Low Fiber Diet for Pediatric Colonoscopy Prep
A study testing Low fiber diet and Standard clear liquid diet in people with Colitis and Gastrointestinal Diseases, run by Rhode Island Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Colitis, Gastrointestinal Diseases, Pediatric Disorder
- What is being tested?
- Low fiber diet and Standard clear liquid diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Apr 2021to 1 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All outpatients undergoing colonoscopy at our institution
Who cannot join
- Unstable medical condition
- Metabolic disease
- Inpatient status
- Requiring an emergency colonoscopy
Trial locations and contacts
1 site in 1 country.
United States1 site
Rhode Island Hospital
Providence, Rhode Island, 02903
About this study
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.
- Conditions
- Colitis, Gastrointestinal Diseases, Pediatric Disorder, Pediatric Crohns Disease, Procedural Sequelae
- Being tested
- Low fiber diet, Standard clear liquid diet
- Medical subject headings
- Colitis, Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low fiber dietDietary supplement
Also called Experimental group
Low fiber diet including cereal, white bread, eggs, meat, dairy
Standard clear liquid dietDietary supplement
Also called Standard group
Standard clear liquid diet including broth, jello, water, juice
| Study group | Role | What they receive |
|---|---|---|
| Low fiber diet group | Experimental | Subjects are allowed a low fiber diet the day of their colonoscopy prep Receives: 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 Receives: Dietary Supplement: Standard clear liquid diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Boston Bowel Prep Score
Scale from 0 - 3 (0 = Unprepared segment colon; 3 = well-visualized segment of colon)
Measured: immediately after the colonoscopy
Secondary outcomes (1)
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)
Measured: immediately before the colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2023
- Study start20 Apr 2021
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Herzlinger, Rhode Island Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05918562
- Sponsor's protocol ID
- 1640783-12
- Status last verified
- Jun 2023
- First submitted
- 31 May 2023
- Last updated
- 26 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Low Fiber Diet for Pediatric Colonoscopy Prep
- ClinicalTrials.gov ID
- NCT05918562
- Acronym / sponsor ID
- 1640783-12
- Conditions
- Colitis, Gastrointestinal Diseases, Pediatric Disorder, Pediatric Crohns Disease, Procedural Sequelae
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Study start
- 20 Apr 2021 (actual)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 26 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low fiber diet group | Experimental | Dietary Supplement: Low fiber dietSubjects are allowed a low fiber diet the day of their colonoscopy prep |
| Clear liquid diet group | Active comparator | Dietary Supplement: Standard clear liquid dietSubjects are allowed a clear liquid diet the day of their colonoscopy prep, as is standard of care |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All outpatients undergoing colonoscopy at our institution
Key exclusion criteria (4 listed)
- Unstable medical condition
- Metabolic disease
- Inpatient status
- Requiring an emergency colonoscopy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low fiber dietAlso: Experimental groupLow fiber diet including cereal, white bread, eggs, meat, dairy | Dietary supplement | Low fiber diet group |
| Standard clear liquid dietAlso: Standard groupStandard clear liquid diet including broth, jello, water, juice | Dietary supplement | Clear liquid diet group |
Primary outcome
Boston Bowel Prep Score
Time frame: immediately after the colonoscopy
Scale from 0 - 3 (0 = Unprepared segment colon; 3 = well-visualized segment of colon)
1 secondary outcome
Patient tolerance
Time frame: immediately before the colonoscopy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low fiber diet and Standard clear liquid diet in people with Colitis and Gastrointestinal Diseases, run by Rhode Island Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Boston Bowel Prep Score (time frame: immediately after the colonoscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2023.