Protocol for Optimizing Colonoscopy Preparation in Patients With Inflammatory Bowel Disease

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04411017

Acronym

EII_Prep

Enrollment

100

Registered

2020-06-01

Start date

2019-02-01

Completion date

2021-07-20

Last updated

2021-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory Bowel Diseases

Keywords

Colonoscopy, Inflammatory Bowel Diseases

Brief summary

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.

Interventions

PROCEDUREEndoscopy

Colonoscopy

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE (Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

Yes

Inclusion criteria

* Patients between 18y and 90y * Patients with a diagnosis of IBD undergoing follow-up or screening colonoscopy

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame	Description
Bowel cleansing	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.

Secondary

Measure	Time frame	Description
Treatment related adverse events	1 year	Number of Participants with symptomatology related to intervention in each arm of the study
Preparation Tolerability: total volume of solution finally taken by the patient	1 year	Evaluation of total volume of solution finally taken by the patient

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026