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

Naval Military Medical University

Status: Not yet enrolling

Conditions: Pronase; Mucosal Clarity

Treatments: Drug: Saline (NaCl 0,9 %) (placebo); Drug: Pronase

Study type: Interventional

Funder types: Other

Identifiers

NCT06874673

CHEC2024-330

Details and patient eligibility

About

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.

Enrollment: 438 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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438 participants in 2 patient groups, including a placebo group

Pronase Group (Group A)

Experimental group

Description:

During colonoscopy, the mucosal surface of the intestine was rinsed with a pronase solution to remove mucus.

Treatment:

Drug: Pronase

Saline Group (Group B)

Placebo Comparator group

Description:

During colonoscopy, the mucosal surface of the intestine was rinsed with saline solution to remove mucus.

Treatment:

Drug: Saline (NaCl 0,9 %) (placebo)