Inflammatory Bowel DiseasesEII_PrepNCT04411017
Protocol for Optimizing Colonoscopy Preparation in Patients With Inflammatory Bowel Disease
A study testing Endoscopy in people with Inflammatory Bowel Diseases, run by Hospital Universitario La Paz at 1 site in Spain.
Trial summary
Clinical trial evaluating efficacy of bowel cleansing solutions in patients with Inflammatory Bowel Disease. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- Endoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2019to 20 Jul 2021
- 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 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients between 18y and 90y
- Patients with a diagnosis of IBD undergoing follow-up or screening colonoscopy
Who cannot join
- Patients <18y or >90y
- Pregnant Women
- Patients with a past history of inadequate bowel cleansing in a colonoscopy performed in the previous 12 months prior to initiation of study
- Patients with a history of bowel resection
- Patients undergoing therapeutic colonoscopy
- Patients unable to understand study protocol
Trial locations and contacts
1 site in 1 country.
About this study
Clinical trial evaluating efficacy of bowel cleansing solutions in patients with Inflammatory Bowel Disease.
Read the detailed description
Simple blind, randomized study evaluating efficacy of 1LPEG vs 2L PEG vs 2L sodium picosulfate in bowel cleansing of patients diagnosed of Inflammatory Bowel Disease undergoing diagnostic or follow-up routine colonoscopy.
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- Endoscopy
- Keywords
- Colonoscopy, Inflammatory Bowel Diseases
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndoscopyProcedure or surgery
Colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| 1L PEG | Active comparator | Not described Receives: Procedure: Endoscopy |
| 2L PEG | Active comparator | Not described Receives: Procedure: Endoscopy |
| 2L sodium picosulfate | Active comparator | Not described Receives: Procedure: Endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bowel cleansing
Boston Bowel Preparation Score (BBPS), a 10-point scale assessing bowel preparation after all cleansing maneuvers are completed by the endoscopist. Each region of the colon receives a "segment score" from 0 to 3 and these segment scores are summed for a total BBPS score ranging from 0 to 9. Therefore, the maximum BBPS score for a perfectly clean colon without any residual liquid is 9 and the minimum BBPS score for an unprepared colon is 0.
Measured: 1 year
Secondary outcomes (2)
Treatment related adverse events
Number of Participants with symptomatology related to intervention in each arm of the study
Measured: 1 year
Preparation Tolerability: total volume of solution finally taken by the patient
Evaluation of total volume of solution finally taken by the patient
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2020
- Study start1 Feb 2019
- Primary completion30 Jun 2021
- Study completion20 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies 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
- Single group
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, María Dolores Martín Arranz, PhD, Hospital Universitario La Paz
- Investigators
- Maria Dolores Martin Arranz, PhD, Principal investigator, Hospital Universitario La Paz. IdiPaz. Universidad Autónoma de Madrid.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04411017
- Sponsor's protocol ID
- EII_Prep
- Acronym
- EII_Prep
- Status last verified
- May 2020
- First submitted
- 24 Jul 2019
- Last updated
- 23 Jul 2021
- 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 23 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol for Optimizing Colonoscopy Preparation in Patients With Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT04411017
- Acronym / sponsor ID
- EII_Prep / EII_Prep
- Conditions
- Inflammatory Bowel Diseases
- Keywords
- Colonoscopy, Inflammatory Bowel Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hospital Universitario La PazUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 20 Jul 2021 (actual)
- First posted
- 1 Jun 2020 (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.
Clinical trial evaluating efficacy of bowel cleansing solutions in patients with Inflammatory Bowel Disease.
Detailed description
Simple blind, randomized study evaluating efficacy of 1LPEG vs 2L PEG vs 2L sodium picosulfate in bowel cleansing of patients diagnosed of Inflammatory Bowel Disease undergoing diagnostic or follow-up routine colonoscopy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1L PEG | Active comparator | Procedure: Endoscopy |
| 2L PEG | Active comparator | Procedure: Endoscopy |
| 2L sodium picosulfate | Active comparator | Procedure: Endoscopy |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients between 18y and 90y
- Patients with a diagnosis of IBD undergoing follow-up or screening colonoscopy
Key exclusion criteria (6 listed)
- Patients <18y or >90y
- Pregnant Women
- Patients with a past history of inadequate bowel cleansing in a colonoscopy performed in the previous 12 months prior to initiation of study
- Patients with a history of bowel resection
- Patients undergoing therapeutic 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 |
|---|---|---|
| EndoscopyColonoscopy | Procedure or surgery | 1L PEG, 2L PEG, 2L sodium picosulfate |
Primary outcome
Bowel cleansing
Time frame: 1 year
Boston Bowel Preparation Score (BBPS), a 10-point scale assessing bowel preparation after all cleansing maneuvers are completed by the endoscopist. Each region of the colon receives a "segment score" from 0 to 3 and these segment scores are summed for a total BBPS score ranging from 0 to 9. Therefore, the maximum BBPS score for a perfectly clean colon without any residual liquid is 9 and the minimum BBPS score for an unprepared colon is 0.
2 secondary outcomes
Treatment related adverse events
Time frame: 1 year
Preparation Tolerability: total volume of solution finally taken by the patient
Time frame: 1 year
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 23 Jul 2021.
- 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.
Maria Dolores Martin Arranz, PhD principal investigator
Hospital Universitario La Paz. IdiPaz. Universidad Autónoma de Madrid.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopy in people with Inflammatory Bowel Diseases, run by Hospital Universitario La Paz at 1 site in Spain.
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 6 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 23 Jul 2021. 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 Spain. 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 cleansing (time frame: 1 year). 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 23 Jul 2021.