App-Based Education and Low-Residue Diet for Colonoscopy Preparation (NCT07395492) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
App-Based Education and Low-Residue Diet for Colonoscopy Preparation
420 participantsStarted 2026-03-01
Plain-language summary
This prospective, randomized, evaluator-blind, parallel-group trial is designed to objectively compare the effectiveness of Advanced Bowel Preparation versus Traditional Bowel Preparation in patients undergoing colonoscopy. In this study, "naive patients" are defined as individuals who have never used Bowklean® as a bowel cleansing agent, or those who may have previously used other bowel preparation regimens but have not undergone any bowel cleansing procedure within the past three years. The Traditional Bowel Preparation approach consists of standard paper-based educational handouts and self-managed low residue dietary restrictions. In contrast, the Advanced Bowel Preparation integrates a smartphone based educational app with a Prepackaged Low-Residue Diet. All participants will use Bowklean®, a bowel preparation agent combining sodium picosulfate, magnesium oxide, and anhydrous citric acid.
The primary endpoint is the percentage of subjects that achieve adequate cleansing (score ≧ 6) in the Boston Bowel Preparation Scale (BBPS).
The secondary endpoints include the percentage of subjects that achieve excellent cleansing (score ≧ 8) in the BBPS, mean score in different colon segments (right, transverse, left), which are assessed with the BBPS, adenoma detection rate, sessile serrated polyp detection rate, and patient satisfaction.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or female 18 to 75 years of age.
. Bowklean naive patient with no bowel preparation in 3 years.
. The subject is scheduled for a colonoscopy.
. Ability to complete the entire procedure and to comply with study instructions.
. Willingness and ability to provide signed informed consent.
Exclusion criteria
. Allergies or hypersensitivity to Bowklean or its ingredients.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of subjects that achieve adequate cleansing
. Severe gastrointestinal conditions (e.g., obstruction, perforation).
. Renal impairment or electrolyte imbalances (e.g., severe hyponatremia).
. Gastrointestinal surgery affects bowel preparation. 2. Patients deemed medically unsuitable for colonoscopy by the physician. 3. Cognitive, language, or other barriers that prevent completion of the questionnaire.