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

Launched by CHANGHAI HOSPITAL · Mar 9, 2025

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ClinConnect Summary

This clinical trial is studying a medication called pronase, which may help improve visibility during colonoscopy exams for patients with colitis, a condition that causes inflammation in the intestines. Pronase works by breaking down mucus, which can sometimes block the view of the intestinal lining during these procedures. The goal of the trial is to see if pronase can safely enhance the clarity of the mucosal surface, making it easier for doctors to conduct the examination and assess the condition of the intestines.

To participate in the trial, you would need to be between 18 and 75 years old and have intestinal inflammation that causes mucus buildup during a colonoscopy. The trial is looking for individuals with inflammatory bowel disease (IBD), regardless of whether they have symptoms like abdominal pain or diarrhea. However, certain individuals, such as those with severe health issues or allergies to pronase, would not be eligible. If you join the study, you'll be randomly assigned to receive either pronase or a placebo (a treatment with no active medication) during your colonoscopy. It's important to know that the trial is currently not recruiting patients but aims to ensure a better understanding and management of conditions related to colitis in the future.

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Eligibility criteria

• 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.