Pronase in Improving Endoscopic Mucosal Clarity During Colonoscopy for Patients with Colitis

NCT06874673 · tracked via the Priya Life Science China tracker

Sponsor

Changhai Hospital

Phase

Not applicable

Started

2025-03-17

Last updated

2025-03-13

Condition(s) studied

PronaseMucosal Clarity

Investigational drug(s) / intervention(s)

PronaseSaline (NaCl 0,9 %) (placebo)

Pronase: During the colonoscopy procedure on participants in Group A, when colitis with mucosal mucus impeding visualization is encountered, the gastroenterologist uses a solution of pronase (200 U/mL) delivered through the endoscope's biopsy forceps to irrigate the affected area. Images are captured before and after the irrigation, and a score for improvement in mucosal clarity is assigned. The location of the lesion, irrigation time, and volume of fluid used are recorded. During endoscope withdrawal, the same area is reassessed for improvement in clarity, and the disease activity is evaluated. Biopsy specimens are taken from the most severe inflammation site for histopathological examination.

Saline (NaCl 0,9 %) (placebo): During the colonoscopy procedure on participants in Group B, when colitis with mucosal mucus impeding visualization is encountered, the gastroenterologist uses saline delivered through the endoscope's biopsy forceps to irrigate the affected area. Images are captured before and after the irrigation, and a score for improvement in mucosal clarity is assigned. The location of the lesion, irrigation time, and volume of fluid used are recorded. During endoscope withdrawal, the same area is reassessed for improvement in clarity, and the disease activity is evaluated. Biopsy specimens are taken from the most severe inflammation site for histopathological examination.

Study summary

Pronase is a proteolytic enzyme known for its ability to clear mucus by breaking down its main component, mucin, through enzymatic hydrolysis. This property makes it useful in gastroscopy, where it is employed to improve the visibility of the mucosal surface during endoscopic examinations. Given the same mechanism, pronase may also be beneficial in enhancing mucosal clarity during colonoscopy. This multicenter, prospective, double-blind randomized controlled trial is designed to assess the effectiveness and safety of pronase in improving mucosal visibility in patients with colitis during endoscopy.

Eligibility

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

Inclusion Criteria: * Patients presenting with intestinal inflammation during colonoscopy, accompanied by mucus obscuring visualization, were included, particularly those with inflammatory bowel disease (IBD), regardless of the presence or absence of clinical symptoms such as abdominal pain, diarrhea, hematochezia, or mucoid stools. * Researchers assessed the current health status of potential participants to ensure they could tolerate colonoscopy (based on physical examination and medical history). * Age range was 18-75 years (inclusive). * Participants provided written informed consent to participate voluntarily. Exclusion Criteria: * Participants with known hypersensitivity or allergy to the study medication. * Participants with peritonitis, intestinal obstruction, severe intestinal infection, or radiation colitis. * Participants who did not exhibit intestinal mucus obscuring endoscopic visualization during colonoscopy. * Participants with severe cardiovascular, pulmonary, neurological, or renal disease, or those deemed unfit for colonoscopy. * Participants who did not provide written informed consent or lacked the capacity to do so. * Pregnant or breastfeeding women. * Participants who had taken antiplatelet medications (e.g., aspirin, clopidogrel) or had abnormal coagulation function within 7 days prior to colonoscopy. * Participants currently participating in other clinical observation trials or who had participated in another clinical trial within 60 days.

Primary outcome measure(s)

Improvement rate of intestinal mucosal clarity after rinsing — From the start of the rinse to 30 seconds after the end of the rinse.
This is defined as a mucosal clarity improvement score of 3 or higher on colonoscopy after rinsing of the mucoid attachment site, signifying achievement of mucosal clarity improvement. The improvement rate is calculated as the percentage of participants within a group who achieve mucosal clarity improvement divided by the total number of participants in that group.

Trial sites (1)

Facility	City	Region	Status
Changhai Hospital, Naval Medical University	Shanghai	Shanghai Municipality

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06874673 on ClinicalTrials.gov ↗ ← All trials in China