Status:

NOT_YET_RECRUITING

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

Lead Sponsor:

Changhai Hospital

Collaborating Sponsors:

Affiliated Hospital of Jiangnan University

The Affiliated People's Hospital of Ningbo University

Conditions:

Pronase

Mucosal Clarity

Eligibility:

All Genders

18-75 years

Phase:

NA

Brief 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...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

March 17 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

November 30 2025

Estimated Enrollment :

438 Patients enrolled

Trial Details

Trial ID

NCT06874673

Start Date

March 17 2025

End Date

November 30 2025

Last Update

March 13 2025

Active Locations (1)

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1

Changhai Hospital, Naval Medical University

Shanghai, Shanghai Municipality, China, 200433

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