NCT06874673Not yet recruiting
Pronase in Improving Endoscopic Mucosal Clarity During Colonoscopy for Patients with Colitis
A Multicenter, Prospective, Double-Blind Randomized Controlled Trial Evaluating the Efficacy and Safety of Pronase in Improving Endoscopic Mucosal Clarity During Colonoscopy for Patients with Colitis
Source: ClinicalTrials.gov · Last updated 13 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 438 (estimated)
- First submitted
- 5 Mar 2025
- Start date
- 17 Mar 2025
- Primary completion date
- 30 Sept 2025
- Lead sponsor
- Changhai Hospital
- Diseases
- Crohn's disease, Ulcerative colitis
- NCT number
- NCT06874673
What you commit to
- Study type: Interventional
- Planned participants: 438
- From 17 Mar 2025 to the primary completion date, 30 Sept 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participants who had taken antiplatelet medications (e.g., aspirin, clopidogrel) or had abnormal coagulation function within 7 days prior to colonoscopy.
Other illness
- Participants with known hypersensitivity or allergy to the study medication.
- Participants with peritonitis, intestinal obstruction, severe intestinal infection, or radiation colitis.
- Participants with severe cardiovascular, pulmonary, neurological, or renal disease, or those deemed unfit for colonoscopy.
Other
- Participants who did not exhibit intestinal mucus obscuring endoscopic visualization during colonoscopy.
- Participants who did not provide written informed consent or lacked the capacity to do so.
- Pregnant or breastfeeding women.
- Participants currently participating in other clinical observation trials or who had participated in another clinical trial within 60 days.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Changhai Hospital, Naval Medical University Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.