Crohn'sUCNot yet recruiting
Pronase in Improving Endoscopic Mucosal Clarity During Colonoscopy for Patients with Colitis
Not applicable · Testing Pronase · 1 site · Changhai Hospital
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Pronase (a drug) as a way to diagnose or measure disease. Condition(s) listed: Pronase and Mucosal Clarity.
Participants are assigned to groups by chance (randomized).
Some participants receive a placebo or sham for comparison.
It is blinded: participants and the study team do not know who receives what.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 to 75
- Any sex
Some of the main requirements, copied from the record:
- 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…
- 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).
Plus 1 more requirement(s). There are also 8 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 438 participants are expected to take part.
- Start date: 2025-03-17 (planned).
- Main results expected around 2025-09-30 (estimate from the record).
- 1 study site listed in China.
Main thing being measured
- Improvement rate of intestinal mucosal clarity after rinsing (From the start of the rinse to 30 seconds after the end of the rinse.)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Pronase; Mucosal Clarity |
| Lead sponsor | Changhai Hospital |
| Collaborators | Affiliated Hospital of Jiangnan University; The Affiliated People's Hospital of Ningbo University; Shanghai 8th People's Hospital; Huashan Hospital; Shanghai Baoshan District Wusong Central Hospital; Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine; Shanghai Pudong Hospital; The People's Hospital of Leshan; Shanghai Pudong New Area Gongli Hospital; Huadong Hospital; Shanghai Songjiang District Central Hospital; Jinshan Hospital Fudan University; Dongfang Hospital Affiliated to Tongji University; Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University |
| Enrollment | 438 (estimated) |
| Start date | 2025-03-17 |
| Primary completion (est.) | 2025-09-30 |
| First posted | 2025-03-13 |
| Last updated | 2025-03-13 |
| Official title | 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 |
| ClinicalTrials.gov ID | NCT06874673 |
Interventions
- Pronase (Drug)
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 o… - Saline (NaCl 0,9 %) (placebo) (Drug)
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 t…
Full eligibility criteria (from the record)
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.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Changhai Hospital, Naval Medical University | Shanghai, Shanghai Municipality | China |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.