App-Based Education and Low-Residue Diet for Colonoscopy Preparation

NCT07395492 | Not Yet Recruiting DMC

• 1 other identifier: 202501149B0
• Study Type: interventional
• Target: 420
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Bowel Preparation Solution

Keywords

Bowklean; Bowel preparation; Low-residue diet; boston bowel preparation scale

Outcome Measures

Primary Outcomes (1)

• Percentage of subjects that achieve adequate cleansing

  The percentage of subjects that achieve adequate cleansing (score ≧ 6) in the Boston Bowel Preparation Scale (BBPS)

  Day1

Secondary Outcomes (5)

• The percentage of subjects that achieve excellent cleansing

  Day1

• Mean score in different colon segments

  Day1

• Adenoma Detection Rate (ADR)

  Day14

• Sessile Serrated Polyp (SSP) Detection Rate

  Day14

• Patient Satisfaction

  Day1

Study Arms (2)

Traditional Bowel Preparation

NO INTERVENTION

The Traditional Bowel Preparation approach consists of standard paper-based educational handouts and self-managed low-residue dietary restrictions.

Advanced Bowel Preparation

EXPERIMENTAL

Advanced Bowel Preparation integrates a smartphone-based educational app (Tian Tian Yi Chi go, developed by UIC Corp.) with a Prepackaged Low-Residue Diet (PLD).

Device: Tian Tian Yi Chi go APP (developed by UIC Corp); Dietary Supplement: Prepackaged Low-Residue Diet

Interventions

Tian Tian Yi Chi go APP (developed by UIC Corp) DEVICE

Bowl preparation educational app

Advanced Bowel Preparation

Prepackaged Low-Residue Diet DIETARY_SUPPLEMENT

Prepackaged Low-Residue Diet

Advanced Bowel Preparation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \. Patients who are unsuitable for Bowklean use due to known contraindications, including but not limited to:
• Allergies or hypersensitivity to Bowklean or its ingredients.
• 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.
• \. Non-compliance with the bowel preparation protocol or inability to follow dietary restrictions (e.g., Prepackaged low residue diet, PLD).
• \. Inability to use or access the mobile APP (e.g., no smartphone, unfamiliarity with APP operations, or technical limitations).
• \. Participation in other clinical trials.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead
• Universal Integrated Corp.: collaborator

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Gastroenterology and Hepatology, Chang Gung Memorial Hospital

Model Details: 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 (Tian Tian Yi Chi go, developed by UIC Corp.) with a Prepackaged Low-Residue Diet (PLD). The app provides timely reminders and interactive guidance, while PLD ensures dietary consistency and reduces errors arising from patient interpretation of dietary instructions.

Study Record Dates

• First Submitted: December 17, 2025
• First Posted: February 9, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): October 21, 2026
• Study Completion (Estimated): October 21, 2026
• Last Updated: February 9, 2026

Record last verified: 2026-02