Children Prior to ColonoscopyNCT02102373
Evaluation of Two Different Diet Regimen Prior to Colonoscopy in Children
A study testing polyethylene glycol 3350 in people with Children Prior to Colonoscopy, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
Colonoscopy is a routinely performed procedure in children and adolescents. Proper visualization of the intestinal mucosa is highly dependent on the quality of the bowel preparation. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Children Prior to Colonoscopy
- What is being tested?
- polyethylene glycol 3350
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 1 sitePoland
- Study dates
- Mar 2014to Apr 2016
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 6-18 years
- Elective colonoscopy
Who cannot join
- Chronic renal, liver, or heart failure
- Acute surgical abdominal conditions (e.g., acute obstruction or perforation)
- Acute surgical abdominal conditions (e.g., acute obstruction or perforation)
- Any prior gastrointestinal surgery
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Pediatric Gastroenterology and Nutrition
Warsaw, 01-184
About this study
Official title: Clear Liquid vs Low-fiber Diet in Bowel Cleansing for Colonoscopy in Children: a Randomized Trial
Colonoscopy is a routinely performed procedure in children and adolescents. Proper visualization of the intestinal mucosa is highly dependent on the quality of the bowel preparation. European Society of Gastrointestinal Endoscopy (ESGE) emphasizes that the timing of bowel preparation is the key factor and recommends that the delay between the last dose of bowel preparation and colonoscopy should be minimized. Timing of bowel preparation prior to colonoscopy has not been studied in children population, yet. The diet regimen before colonoscopy is likely less important than the timing of bowel preparation, however may influence the well-being of children.
- Conditions
- Children Prior to Colonoscopy
- Being tested
- polyethylene glycol 3350
- Keywords
- colonoscopy, pediatric, preparation, diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
polyethylene glycol 3350Device
Also called Forlax
Patients received a polyethylene glycol 3350 solution starting at afternoon the day before the colonoscopy at a dose of 1000 ml/15 kg (maximum 4 L). The patients were instructed to drink all solution in about 4-6 hours.
| Study group | Role | What they receive |
|---|---|---|
| low-fiber diet | Active comparator | Patients received low-fiber diet for 24 hours before colonoscopy Receives: Device: polyethylene glycol 3350 |
| clear liquid diet | Active comparator | Patients received clear liquid diet for 24 hours before colonoscopy Receives: Device: polyethylene glycol 3350 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bowel preparation of the whole colon
Boston bowel preparation score for the whole colon assessed by the endoscopist in 15 minutes after the procedure
Measured: in 15 minutes after colonoscopy
Secondary outcomes (5)
Bowel preparation for colon sections
Boston bowel preparation score for:
- the right side of the colon
- the transverse section of the colon
- the left side of the colon assessed by the endoscopist in 15 minutes after the colonoscopy
Measured: in 15 minutes after colonoscopy
Duration of PEG taking
Measured: in 15 minutes after colonoscopy
Time between the last dose of PEG and colonoscopy
Measured: in 15 minutes after colonoscopy
Acceptability
Patient's satisfaction of bowel preparation measured by 10-point visual-analogue scale (VAS)
Measured: in the first 6 hours after colonoscopy
Tolerability
Tolerability assessment was based on the recording of occurrence and severity of GI symptoms such as nausea, bloating, abdominal, pain/cramps and anal discomfort
Measured: in the first 6 hours after colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2014 (estimated)
- Study startMar 2014
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Children Prior to ColonoscopyStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aleksandra Banaszkiewicz, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02102373
- Sponsor's protocol ID
- Mytyk2014
- Status last verified
- Apr 2017
- First submitted
- 26 Mar 2014
- Last updated
- 25 Apr 2017
- Results posted
- No
- Individual data sharing
- No
Publications
Mytyk A, Lazowska-Przeorek I, Karolewska-Bochenek K, Kakol D, Banasiuk M, Walkowiak J, Albrecht P, Banaszkiewicz A. Clear Liquid Versus Low-fibre Diet in Bowel Cleansing for Colonoscopy in Children: A Randomized Trial. J Pediatr Gastroenterol Nutr. 2018 May;66(5):720-724. doi: 10.1097/MPG.0000000000001832.
PubMed 29112090
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clear Liquid vs Low-fiber Diet in Bowel Cleansing for Colonoscopy in Children: a Randomized Trial
- ClinicalTrials.gov ID
- NCT02102373
- Acronym / sponsor ID
- Mytyk2014
- Conditions
- Children Prior to Colonoscopy
- Keywords
- colonoscopy, pediatric, preparation, diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 2 Apr 2014 (estimated)
- 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.
Colonoscopy is a routinely performed procedure in children and adolescents. Proper visualization of the intestinal mucosa is highly dependent on the quality of the bowel preparation. European Society of Gastrointestinal Endoscopy (ESGE) emphasizes that the timing of bowel preparation is the key factor and recommends that the delay between the last dose of bowel preparation and colonoscopy should be minimized. Timing of bowel preparation prior to colonoscopy has not been studied in children population, yet. The diet regimen before colonoscopy is likely less important than the timing of bowel preparation, however may influence the well-being of children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low-fiber diet | Active comparator | Device: polyethylene glycol 3350Patients received low-fiber diet for 24 hours before colonoscopy |
| clear liquid diet | Active comparator | Device: polyethylene glycol 3350Patients received clear liquid diet for 24 hours before colonoscopy |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Age 6-18 years
- Elective colonoscopy
Key exclusion criteria (4 listed)
- Chronic renal, liver, or heart failure
- Acute surgical abdominal conditions (e.g., acute obstruction or perforation)
- Acute surgical abdominal conditions (e.g., acute obstruction or perforation)
- Any prior gastrointestinal surgery
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 |
|---|---|---|
| polyethylene glycol 3350Also: ForlaxPatients received a polyethylene glycol 3350 solution starting at afternoon the day before the colonoscopy at a dose of 1000 ml/15 kg (maximum 4 L). The patients were instructed to drink all solution in about 4-6 hours. | Device | clear liquid diet, low-fiber diet |
Primary outcome
Bowel preparation of the whole colon
Time frame: in 15 minutes after colonoscopy
Boston bowel preparation score for the whole colon assessed by the endoscopist in 15 minutes after the procedure
5 secondary outcomes
Bowel preparation for colon sections
Time frame: in 15 minutes after colonoscopy
Duration of PEG taking
Time frame: in 15 minutes after colonoscopy
Time between the last dose of PEG and colonoscopy
Time frame: in 15 minutes after colonoscopy
Acceptability
Time frame: in the first 6 hours after colonoscopy
Tolerability
Time frame: in the first 6 hours after colonoscopy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2017.
- Derived from this study: PubMed 29112090Mytyk A, Lazowska-Przeorek I, Karolewska-Bochenek K, Kakol D, Banasiuk M, Walkowiak J, Albrecht P, Banaszkiewicz A. Clear Liquid Versus Low-fibre Diet in Bowel Cleansing for Colonoscopy in Children: A Randomized Trial. J Pediatr Gastroenterol Nutr. 2018 May;66(5):720-724. doi: 10.1097/MPG.0000000000001832.
- Bowel preparation for colonoscopy: European Society of Gastrointestinal Endoscopy (ESGE) GuidelineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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 polyethylene glycol 3350 in people with Children Prior to Colonoscopy, run by Medical University of Warsaw at 1 site in Poland.
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 2 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: finished, as of the sponsor's last update on 25 Apr 2017. 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 Poland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Bowel preparation of the whole colon (time frame: in 15 minutes after colonoscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02102373, which also lists 1 linked publication.
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 25 Apr 2017.