Capsule EndoscopyPhase 4PREP-CENCT01783782
Small Bowel Cleansing for Capsule Endoscopy in Pediatric Patients
A Phase 4 study testing DIET, polyethylene glycol 4000 solution with simethicon and simethicon in people with Capsule Endoscopy, run by Azienda Policlinico Umberto I at 1 site in Italy.
Trial summary
The primary aim of this prospective, randomized and controlled study was to evaluate the effect of five bowel preparation regimens on small-bowel cleansing in a pediatric population. The secondary endpoints were to evaluate the safety and the effects of preparation on diagnostic yield of CE. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Capsule Endoscopy
- What is being tested?
- DIET, polyethylene glycol 4000 solution with simethicon and simethicon
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2005to Sep 2013
- Phase
- Phase 4
- 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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients undergoing elective Small Bowel capsule endoscopy in our Institution between 2 and 18 years of age were recruited for this study.
Who cannot join
- intestinal obstruction,
- suspicious impaired intestinal motility,
- history of gastrointestinal surgery
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Departments of Pediatrics, Sapienza - University of Rome
Rome, Rome, 00161
Giovanni Di Nardo, MD, +390649979326, giovanni.dinardo@uniroma1.it
Giovanni Di Nardo, MD
About this study
Official title: SMALL BOWEL CLEANSING FOR CAPSULE ENDOSCOPY IN PEDIATRIC PATIENTS: A PROSPECTIVE RANDOMIZED SINGLE-BLINDED STUDY
The primary aim of this prospective, randomized and controlled study was to evaluate the effect of five bowel preparation regimens on small-bowel cleansing in a pediatric population. The secondary endpoints were to evaluate the safety and the effects of preparation on diagnostic yield of CE.
Read the detailed description
Capsule endoscopy (CE) is a well-known, non-invasive, diagnostic tool to evaluate small bowel diseases in adults and children. Unfortunately, because CE does not have functions which allow suctioning of fluid or washing the small bowel mucosa during the examination, its diagnostic yield can be limited by presence of debris, biliary secretion, bubbles and blood in the gut lumen that may hide relevant findings especially in the distal small bowel. In addition, CE sometimes fails to reach the cecum within the battery life of the capsule, resulting in a failure to visualize the distal small intestine. However, in children this problem is less frequent for the increased intestinal motility, which reduces the transit time of the capsule.
It was believed that cleaning the small intestine prior to examination would improve mucosal visibility during the endoscopy and, as a result, the diagnostic yield of the technique. Therefore, proposals were put forward based on preparations for other types of explorations, such as colonoscopies (2).
Some authors have already studied in adults the effect of bowel preparation on small-bowel visualization using different agents; the results of the published series are contradictory. To date, while there is evidence for a benefit from bowel preparation for CE, there is so far no consensus on an optimal preparation regimen. In addition, in children there are not studies on this topic. Therefore, overnight fasting before the examination still remains the proposed preparation for capsule endoscopy.
- Conditions
- Capsule Endoscopy
- Being tested
- DIET, polyethylene glycol 4000 solution with simethicon, simethicon
- Keywords
- Capsule Endoscopy, colon cleansing, children, age 2 -18 years
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DIETBehavioural
clear liquid diet for 12 hours on the day before CE, followed by an overnight fast
polyethylene glycol 4000 solution with simethiconDrug
Also called selg-esse
patients received a high volume regime consisting of a 50 mL/Kg (up to 2 Lt/die) of PEG solution the evening before the examination, followed always by an overnight fast
simethiconDrug
Also called Panamir V
Patients received 20 mL oral simethicone (Panamir, DMG, Italy, containing 40 mg simethicone in 1mL emulsion) and 200mL water 30 minutes before capsule ingestion
| Study group | Role | What they receive |
|---|---|---|
| DIET | Experimental | Group A followed the standard regime consisting of a clear liquid diet for 12 hours on the day before CE, followed by an overnight fast. Receives: Behavioral: DIET |
| HIGH PEG | Experimental | Group B received a high volume regime consisting of a 50 mL/Kg (up to 2 Lt/die) of polyethylene glycol 4000 solution with simethicon solution the evening before the examination, followed always by an overnight fast. Receives: Drug: polyethylene glycol 4000 solution with simethicon |
| LOW PEG | Experimental | Group C, defined as a low volume regime, received 25 mL/Kg (up to 1Lt/die) of polyethylene glycol 4000 solution with simethicon solution the evening before the examination, followed by an overnight fast. Receives: Drug: polyethylene glycol 4000 solution with simethicon |
| SIMETHICONE | Experimental | Group D received 20 mL oral simethicone (Panamir, DMG, Italy, containing 40 mg simethicone in 1mL emulsion) and 200mL water 30 minutes before capsule ingestion. Receives: Drug: simethicon |
| SIMETH+PEG | Experimental | Group E received 25 mL/Kg (up to 1 Lt/die) of polyethylene glycol 4000 solution with simethicon solution followed by an overnight fast plus 20mL oral simethicone and 200mL water 30 minutes before capsule ingestion. Receives: Drug: polyethylene glycol 4000 solution with simethicon; Drug: simethicon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy
Preparation efficacy was evaluated by the blinded endoscopist according to a visibility score.
There is no standardized or validated scoring system for the quality of small-bowel cleanliness. The visibility of the mucosal surface was assessed as the percentage of visualized bowel surface area as follows: 1: < 25%; 2: 25%-49%; 3: 50%-74%; 4: 75%-89%; 5: > 90%.
Measured: During the performance of capsule endoscopy
Secondary outcomes (3)
Efficacy
the number of positive findings and the overall diagnostic yield.
A positive finding was defined as the presence of a visible finding, whether incidental or clinically relevant. A positive yield at CE was assumed if the visible finding was considered relevant to the indication for CE. Where appropriate, this was confirmed by further evaluation (repeated upper-GI or lower-GI endoscopy, single-balloon enteroscopy (SBE), laparotomy, or cross-sectional imaging).
Measured: during the reading capsule endoscopy
Safety
Adverse events were assessed on the day of capsule endoscopy by direct questioning and by telephone interview 48-96 hours after capsule endoscopy.
Measured: 4 days
clinical tolerabiity
Tolerability assessment was based on the recording of occurrence and severity of GI symptoms such as nausea, bloating, abdominal, pain/cramps and anal discomfort.
All patients were tested with a questionnaire, based on a numerical scale between 0 and 10 (with 10 being no burden at all and 0 indicating an intolerable procedure), about the impact of the bowel preparation (Van Tuyl Endoscopy 2007) and their level of satisfaction.
Measured: On the morning of colonoscopy, immediately before the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2013 (estimated)
- Study startNov 2005
- Primary completionAug 2013 (estimated)
- Study completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Capsule EndoscopyStudies 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 4
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Policlinico Umberto I
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giovanni Di Nardo, Azienda Policlinico Umberto I
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01783782
- Sponsor's protocol ID
- CLEANSING FOR PED-CE
- Acronym
- PREP-CE
- Status last verified
- Nov 2005
- First submitted
- 1 Feb 2013
- Last updated
- 5 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SMALL BOWEL CLEANSING FOR CAPSULE ENDOSCOPY IN PEDIATRIC PATIENTS: A PROSPECTIVE RANDOMIZED SINGLE-BLINDED STUDY
- ClinicalTrials.gov ID
- NCT01783782
- Acronym / sponsor ID
- PREP-CE / CLEANSING FOR PED-CE
- Conditions
- Capsule Endoscopy
- Keywords
- Capsule Endoscopy, colon cleansing, children, age 2 -18 years
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Azienda Policlinico Umberto IUniversity, hospital or other
- Study start
- Nov 2005
- Primary completion
- Aug 2013 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 5 Feb 2013 (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.
The primary aim of this prospective, randomized and controlled study was to evaluate the effect of five bowel preparation regimens on small-bowel cleansing in a pediatric population. The secondary endpoints were to evaluate the safety and the effects of preparation on diagnostic yield of CE.
Detailed description
Capsule endoscopy (CE) is a well-known, non-invasive, diagnostic tool to evaluate small bowel diseases in adults and children. Unfortunately, because CE does not have functions which allow suctioning of fluid or washing the small bowel mucosa during the examination, its diagnostic yield can be limited by presence of debris, biliary secretion, bubbles and blood in the gut lumen that may hide relevant findings especially in the distal small bowel. In addition, CE sometimes fails to reach the cecum within the battery life of the capsule, resulting in a failure to visualize the distal small intestine. However, in children this problem is less frequent for the increased intestinal motility, which reduces the transit time of the capsule.
It was believed that cleaning the small intestine prior to examination would improve mucosal visibility during the endoscopy and, as a result, the diagnostic yield of the technique. Therefore, proposals were put forward based on preparations for other types of explorations, such as colonoscopies (2).
Some authors have already studied in adults the effect of bowel preparation on small-bowel visualization using different agents; the results of the published series are contradictory. To date, while there is evidence for a benefit from bowel preparation for CE, there is so far no consensus on an optimal preparation regimen. In addition, in children there are not studies on this topic. Therefore, overnight fasting before the examination still remains the proposed preparation for capsule endoscopy.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| DIET | Experimental | Behavioral: DIETGroup A followed the standard regime consisting of a clear liquid diet for 12 hours on the day before CE, followed by an overnight fast. |
| HIGH PEG | Experimental | Drug: polyethylene glycol 4000 solution with simethiconGroup B received a high volume regime consisting of a 50 mL/Kg (up to 2 Lt/die) of polyethylene glycol 4000 solution with simethicon solution the evening before the examination, followed always by an overnight fast. |
| LOW PEG | Experimental | Drug: polyethylene glycol 4000 solution with simethiconGroup C, defined as a low volume regime, received 25 mL/Kg (up to 1Lt/die) of polyethylene glycol 4000 solution with simethicon solution the evening before the examination, followed by an overnight fast. |
| SIMETHICONE | Experimental | Drug: simethiconGroup D received 20 mL oral simethicone (Panamir, DMG, Italy, containing 40 mg simethicone in 1mL emulsion) and 200mL water 30 minutes before capsule ingestion. |
| SIMETH+PEG | Experimental | Drug: polyethylene glycol 4000 solution with simethicon, Drug: simethiconGroup E received 25 mL/Kg (up to 1 Lt/die) of polyethylene glycol 4000 solution with simethicon solution followed by an overnight fast plus 20mL oral simethicone and 200mL water 30 minutes before capsule ingestion. |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patients undergoing elective Small Bowel capsule endoscopy in our Institution between 2 and 18 years of age were recruited for this study.
Key exclusion criteria (3 listed)
- intestinal obstruction,
- suspicious impaired intestinal motility,
- history of 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 |
|---|---|---|
| DIETclear liquid diet for 12 hours on the day before CE, followed by an overnight fast | Behavioural | DIET |
| polyethylene glycol 4000 solution with simethiconAlso: selg-essepatients received a high volume regime consisting of a 50 mL/Kg (up to 2 Lt/die) of PEG solution the evening before the examination, followed always by an overnight fast | Drug | HIGH PEG, LOW PEG, SIMETH+PEG |
| simethiconAlso: Panamir VPatients received 20 mL oral simethicone (Panamir, DMG, Italy, containing 40 mg simethicone in 1mL emulsion) and 200mL water 30 minutes before capsule ingestion | Drug | SIMETH+PEG, SIMETHICONE |
Primary outcome
Efficacy
Time frame: During the performance of capsule endoscopy
Preparation efficacy was evaluated by the blinded endoscopist according to a visibility score. There is no standardized or validated scoring system for the quality of small-bowel cleanliness. The visibility of the mucosal surface was assessed as the percentage of visualized bowel surface area as follows: 1: < 25%; 2: 25%-49%; 3: 50%-74%; 4: 75%-89%; 5: > 90%.
3 secondary outcomes
Efficacy
Time frame: during the reading capsule endoscopy
Safety
Time frame: 4 days
clinical tolerabiity
Time frame: On the morning of colonoscopy, immediately before the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2013.
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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.
Departments of Pediatrics, Sapienza - University of Rome
Rome, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing DIET, polyethylene glycol 4000 solution with simethicon and simethicon in people with Capsule Endoscopy, run by Azienda Policlinico Umberto I at 1 site in Italy.
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 3 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 5 Feb 2013. 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 Italy. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy (time frame: During the performance of capsule endoscopy). 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 5 Feb 2013.