PronaseNCT06874673
Pronase in Improving Endoscopic Mucosal Clarity During Colonoscopy for Patients with Colitis
A study testing Pronase in people with Pronase and Mucosal Clarity, run by Changhai Hospital at 1 site in China.
Trial 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 employed to improve the visibility of the mucosal surface during endoscopic examinations. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pronase, Mucosal Clarity
- What is being tested?
- Pronase
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 438 participants
- Where
- 1 siteChina
- Study dates
- 17 Mar 2025to 30 Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Changhai Hospital, Naval Medical University
Shanghai, Shanghai Municipality, 200433
Huan-Wei Zhang, +86-19921942094, zhanghuanwei@smmu.edu.cn
About this study
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
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.
- Conditions
- Pronase, Mucosal Clarity
- Being tested
- Pronase, Saline (NaCl 0,9 %) (placebo)
- Keywords
- Pronase, Colonoscopy, Mucosal Clarity, Colitis, Ulcerative Colitis, Crohn's Disease, inflammatory bowel disease
- Medical subject headings
- Colitis, Colitis, Ulcerative, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PronaseDrug
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 of the lesion, irrigation time, and volume of fluid used are recorded. During endoscope withdrawal, the same area is reassessed for improvement in clarity, and the disease activity is evaluated. Biopsy specimens are taken from the most severe inflammation site for histopathological examination.
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 time, and volume of fluid used are recorded. During endoscope withdrawal, the same area is reassessed for improvement in clarity, and the disease activity is evaluated. Biopsy specimens are taken from the most severe inflammation site for histopathological examination.
| Study group | Role | What they receive |
|---|---|---|
| Pronase Group (Group A) | Experimental | During colonoscopy, the mucosal surface of the intestine was rinsed with a pronase solution to remove mucus. Receives: Drug: Pronase |
| Saline Group (Group B) | Placebo comparator | During colonoscopy, the mucosal surface of the intestine was rinsed with saline solution to remove mucus. Receives: Drug: Saline (NaCl 0,9 %) (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement rate of intestinal mucosal clarity after rinsing
This is defined as a mucosal clarity improvement score of 3 or higher on colonoscopy after rinsing of the mucoid attachment site, signifying achievement of mucosal clarity improvement. The improvement rate is calculated as the percentage of participants within a group who achieve mucosal clarity improvement divided by the total number of participants in that group.
Measured: From the start of the rinse to 30 seconds after the end of the rinse.
Secondary outcomes (6)
Colonoscopist satisfaction score
This reflects the overall satisfaction of the colonoscopist with the effect of the rinsing solution on mucosal clarity, measured using a 5-point Likert scale.Scores range from 5 to 1, with higher scores meaning better results.
Measured: From start to finish of the colonoscopy.
Rinsing solution volume
This is defined as the volume of liquid consumed during rinsing of the area with the most severe mucosal mucus adhesion in each case.
Measured: From the start of the rinse to 30 seconds after the end of the rinse.
Ulcerative colitis endoscopic index of severity，UCEIS
The UCEIS score is a standardized tool for assessing the severity of inflammation in ulcerative colitis (UC) based on three core features: vascular Pattern, bleeding, and erosions/ulcers, as viewed through enteroscopy, with a total score of 0-8, with higher scores suggesting more severe lesions.
Measured: From the start of the rinse to 30 seconds after the end of the rinse.
Endoscopic severity index of Crohn's disease, CDEIS
The CDEIS is based on the assessment of 4 parameters (deep ulcers, shallow ulcers, extent of surface involvement, and extent of ulcer involvement) in 5 sites (terminal ileum, right hemicolon, transverse colon, left hemisphere and sigmoid colon, and rectum), and the total score for an individual segment divided by the number of segments assessed, plus the presence or absence of stenosis yields a total score that ranges from 0 ~ 44 points, with higher scores suggestive of more severe lesions.
Measured: From the start of the rinse to 30 seconds after the end of the rinse.
Simplified Geboes Score, SGS
The Simplified Geboes Score evaluates the degree of tissue inflammation by assessing neutrophils in the lamina propria, neutrophils in the epithelium and epithelial damage in the crypts and mucosal surfaces. The scale is as follows: grade 0 represents structural abnormalities or chronic infiltration without active inflammation; grade 1 represents basal plasmacytosis; grade 2 represents inflammatory cell infiltration in the lamina propria; grade 3 represents neutrophil infiltration in the epithelium; grade 4 represents crypt epithelial damage and grade 5 represents surface epithelial damage.
Measured: From the start of the rinse to 30 seconds after the end of the rinse.
Colonic and ileal global histologic disease activity scores, CGHAS
The CGHAS scoring system evaluates mucosal inflammation levels in Crohn's disease patients through histological assessment of mucosal tissue biopsies. Its assessment parameters include: lamina propria inflammatory cell infiltration (e.g., neutrophils, mononuclear cells); chronic structural damage (e.g., crypt distortion, glandular architectural disarray); epithelial injury (e.g., erosions, ulcerations); and the extent of lesion involvement (quantified by the number of affected biopsy specimens). The scoring scale ranges from 0 to 16 points, with higher scores indicating more severe inflammatory activity.
Measured: From the start of the rinse to 30 seconds after the end of the rinse.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start17 Mar 2025 (estimated)
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PronaseStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 438 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Zhaoshen Li, Changhai Hospital
- Investigators
- Zhao-Shen Li, MD, PhD, Study chair, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06874673
- Sponsor's protocol ID
- CHEC2024-330
- Status last verified
- Mar 2025
- First submitted
- 5 Mar 2025
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kuo CH, Sheu BS, Kao AW, Wu CH, Chuang CH. A defoaming agent should be used with pronase premedication to improve visibility in upper gastrointestinal endoscopy. Endoscopy. 2002 Jul;34(7):531-4. doi: 10.1055/s-2002-33220.
PubMed 12170403Han JP, Hong SJ, Moon JH, Lee GH, Byun JM, Kim HJ, Choi HJ, Ko BM, Lee MS. Benefit of pronase in image quality during EUS. Gastrointest Endosc. 2011 Dec;74(6):1230-7. doi: 10.1016/j.gie.2011.07.044. Epub 2011 Oct 1.
PubMed 21963063
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- Acronym / sponsor ID
- CHEC2024-330
- Conditions
- Pronase, Mucosal Clarity
- Keywords
- Pronase, Colonoscopy, Mucosal Clarity, Colitis, Ulcerative Colitis, Crohn's Disease, inflammatory bowel disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 438 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- 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
- Study start
- 17 Mar 2025 (estimated)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 13 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pronase Group (Group A) | Experimental | Drug: PronaseDuring colonoscopy, the mucosal surface of the intestine was rinsed with a pronase solution to remove mucus. |
| Saline Group (Group B) | Placebo comparator | Drug: Saline (NaCl 0,9 %) (placebo)During colonoscopy, the mucosal surface of the intestine was rinsed with saline solution to remove mucus. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PronaseDuring 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 of the lesion, irrigation time, and volume of fluid used are recorded. During endoscope withdrawal, the same area is reassessed for improvement in clarity, and the disease activity is evaluated. Biopsy specimens are taken from the most severe inflammation site for histopathological examination. | Drug | Pronase Group (Group A) |
| Saline (NaCl 0,9 %) (placebo)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 time, and volume of fluid used are recorded. During endoscope withdrawal, the same area is reassessed for improvement in clarity, and the disease activity is evaluated. Biopsy specimens are taken from the most severe inflammation site for histopathological examination. | Drug | Saline Group (Group B) |
Primary outcome
Improvement rate of intestinal mucosal clarity after rinsing
Time frame: From the start of the rinse to 30 seconds after the end of the rinse.
This is defined as a mucosal clarity improvement score of 3 or higher on colonoscopy after rinsing of the mucoid attachment site, signifying achievement of mucosal clarity improvement. The improvement rate is calculated as the percentage of participants within a group who achieve mucosal clarity improvement divided by the total number of participants in that group.
6 secondary outcomes
Colonoscopist satisfaction score
Time frame: From start to finish of the colonoscopy.
Rinsing solution volume
Time frame: From the start of the rinse to 30 seconds after the end of the rinse.
Ulcerative colitis endoscopic index of severity，UCEIS
Time frame: From the start of the rinse to 30 seconds after the end of the rinse.
Endoscopic severity index of Crohn's disease, CDEIS
Time frame: From the start of the rinse to 30 seconds after the end of the rinse.
Simplified Geboes Score, SGS
Time frame: From the start of the rinse to 30 seconds after the end of the rinse.
Colonic and ileal global histologic disease activity scores, CGHAS
Time frame: From the start of the rinse to 30 seconds after the end of the rinse.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Background: PubMed 12170403Kuo CH, Sheu BS, Kao AW, Wu CH, Chuang CH. A defoaming agent should be used with pronase premedication to improve visibility in upper gastrointestinal endoscopy. Endoscopy. 2002 Jul;34(7):531-4. doi: 10.1055/s-2002-33220.
- Background: PubMed 21963063Han JP, Hong SJ, Moon JH, Lee GH, Byun JM, Kim HJ, Choi HJ, Ko BM, Lee MS. Benefit of pronase in image quality during EUS. Gastrointest Endosc. 2011 Dec;74(6):1230-7. doi: 10.1016/j.gie.2011.07.044. Epub 2011 Oct 1.
Related trials for Pronase
Recruiting
Effect of Premedication With Pronase on Mucosal Cleanliness During EGD
Esophageal Cancer, Gastric Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhao-Shen Li, MD, PhD study chair
Changhai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pronase in people with Pronase and Mucosal Clarity, run by Changhai Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Huan-Wei Zhang (86-19921942094, zhanghuanwei@smmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement rate of intestinal mucosal clarity after rinsing (time frame: From the start of the rinse to 30 seconds after the end of the rinse.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06874673, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.