Pancreatic Exocrine Insufficiency, AdulNCT07751367
A Study on the Efficacy of Different Doses of Oryz-Aspergillus Enzyme And Pancreatin Tablet in Treating Pancreatic Exocrine Insufficiency After Gastrointestinal Surgery
A study testing High-dose group: Oryz-Aspergillus Enzyme and Pancreatin Tablet and Low-dose group: Oryz-Aspergillus Enzyme And Pancreatin Tablet in people with Pancreatic Exocrine Insufficiency, Adul, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
This study aims to investigate the efficacy and safety of high-dose Oryz-Aspergillus Enzyme And Pancreatin Tablet in treating postoperative pancreatic exocrine insufficiency (PEI), aiming to fill the gap in evidence-based medicine and promote standardized treatment. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Exocrine Insufficiency, Adul
- What is being tested?
- High-dose group: Oryz-Aspergillus Enzyme and Pancreatin Tablet and Low-dose group: Oryz-Aspergillus Enzyme And Pancreatin Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 18 Sep 2026to 31 Dec 2028
- 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
- Age between 18 and 75 years (inclusive of boundary values), regardless of gender;
- History of prior gastrointestinal surgical treatment, including but not limited to:
- Post-pancreatectomy patients within 3-6 months (e.g., distal pancreatectomy, mid-pancreatectomy, total pancreatectomy, pancreatoduodenectomy); II. Post-gastrectomy patients within 2-6 months (e.g., partial gastrectomy excluding total gastrectomy);
- For tumor patients, the primary tumor stage before or during surgery must be Stage I or II (AJCC 8th edition). Patients in the interval between anti-tumor treatments must have undergone a washout period exceeding 28 days to avoid interference from anti-tumor therapy on this study;
- Diagnosis of pancreatic exocrine insufficiency (PEI) based on comprehensive assessment by the investigator considering medical history, symptoms, nutritional status, and pancreatic function;
- Gastrointestinal Quality of Life Index (GIQLI) score ≤ 105 points;
- Stable postoperative condition without systemic infection, anastomotic leak, or other severe postoperative complications;
- Participants fully understand the study and voluntarily sign a written informed consent form approved by the ethics committee.
Who cannot join
- Known allergy to any component of micafungin pancreatic enzyme tablets;
- Patients with acute pancreatitis or acute exacerbation during active phase of chronic pancreatitis, or those with known contraindications listed in the product label;
- Patients with rare inherited fructose intolerance, glucose-galactose malabsorption, or sucrose-isomaltase deficiency
- Gastrointestinal obstruction;
- Use of other digestive enzyme replacement therapies during the study period;
- Coexisting decompensated cirrhosis, active hepatitis with significant hepatic dysfunction, or other definite severe chronic diseases clearly affecting gastrointestinal motility and absorption (e.g., active inflammatory bowel disease); diabetes is not an exclusion criterion but must be documented in detail regarding type and treatment regimen;
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- Tumor patients who had distant metastasis (M1) preoperatively (AJCC 8th edition) or locally advanced unresectable tumors requiring non-curative surgery. Patients who received neoadjuvant chemotherapy/radiotherapy/targeted therapy or other systemic anti-tumor treatments prior to or during surgery, even if the primary tumor was staged as Stage I or II;
- Post-gastrointestinal surgery patients diagnosed clinically with gastroparesis, or meeting any of the following criteria for diagnosing delayed gastric emptying (DGE):
- I.Chronic refractory gastroparesis: duration > 6 months post-surgery, with persistent symptoms at moderate or greater severity despite standardized prokinetic therapy (e.g., metoclopramide, domperidone, erythromycin); II.Severe gastroparesis symptoms present at screening, which are the primary reason for patient visit; the researcher assesses symptom severity as equivalent to or worse than symptoms potentially caused by PEI (e.g., steatorrhea); III.Invasive interventions due to gastroparesis: such as placement of jejunal feeding tube, pyloric dilation, or surgical reconstruction, and still dependent on these measures for nutritional support;
- Currently participating in another clinical trial, or recently completed another clinical trial without having reached the required washout period (within 28 days);
- Other patients judged by the investigator as unsuitable for participation in this clinical trial.
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
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300000
Jihui Hao M.D., 022-23524155, ec_tjcih@126.com
About this study
Official title: A Multicenter, Open-Label, Randomized Controlled Trial on the Efficacy and Safety of Different Doses of Oryz-Aspergillus Enzyme And Pancreatin Tablet in Treating Pancreatic Exocrine Insufficiency After Gastrointestinal Surgery
This study aims to investigate the efficacy and safety of high-dose Oryz-Aspergillus Enzyme And Pancreatin Tablet in treating postoperative pancreatic exocrine insufficiency (PEI), aiming to fill the gap in evidence-based medicine and promote standardized treatment.
- Conditions
- Pancreatic Exocrine Insufficiency, Adul
- Being tested
- High-dose group: Oryz-Aspergillus Enzyme and Pancreatin Tablet, Low-dose group: Oryz-Aspergillus Enzyme And Pancreatin Tablet
- Medical subject headings
- Exocrine Pancreatic Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-dose group: Oryz-Aspergillus Enzyme and Pancreatin TabletDrug
High-dose group: Oryz-Aspergillus Enzyme And Pancreatin Tablet, 5 tablets each time, three times daily, taken with each main meal or after meals, continuous administration for 4 weeks (28 days);
Low-dose group: Oryz-Aspergillus Enzyme And Pancreatin TabletDrug
Low-dose group: Oral study drug:Oryz-Aspergillus Enzyme And Pancreatin Tablet, 1 tablet each time, three times daily, taken with each main meal or after meals, continuous administration for 4 weeks (28 days).
| Study group | Role | What they receive |
|---|---|---|
| High-dose group | Active comparator | Oryz-Aspergillus Enzyme And Pancreatin Tablet Receives: Drug: High-dose group: Oryz-Aspergillus Enzyme and Pancreatin Tablet |
| Low-dose group | Experimental | Oryz-Aspergillus Enzyme And Pancreatin Tablet Receives: Drug: Low-dose group: Oryz-Aspergillus Enzyme And Pancreatin Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Gastrointestinal Symptom Rating Scale (GSRS) from baseline in the two groups of patients before treatment, after 5 days of treatment, and after 4 weeks of treatment
Scale Full Name: Gastrointestinal Symptom Rating Scale (GSRS) The total score ranges from 15 (lowest, no symptoms) to 105 (highest, all symptoms extremely severe).
Higher scores mean a worse outcome.
Measured: 5 days,4 weeks
Secondary outcomes (8)
Change in nutritional status scores (NRS 2002 scale) of the two groups of patients after 4 weeks of treatment compared to baseline
Full name of the scale: Nutritional Risk Screening 2002 (NRS-2002) The NRS-2002 uses a weighted scoring system with a total score ranging from from 0 points (lowest) to 7 points (highest), consisting of four independent modules: disease severity score, nutritional status impairment score, age adjustment, and final integrated assessment criteria. A patient is considered to have a nutritional risk only if the total score is ≥3, warranting further nutritional assessment and medical nutrition intervention.
higher scores mean a worse outcome
Measured: 4 weeks
Laboratory values after 4 weeks of treatment in the two groups: changes in total protein levels
Measured: 4 weeks
Laboratory values after 4 weeks of treatment in the two groups: changes in albumin levels
Measured: 4 weeks
Laboratory values after 4 weeks of treatment in the two groups: changes in globulin levels
Measured: 4 weeks
Laboratory values after 4 weeks of treatment in the two groups: changes in prealbumin levels
Measured: 4 weeks
Laboratory values after 4 weeks of treatment in the two groups: changes in transferrin levels
Measured: 4 weeks
Weight changes from baseline after 4 weeks of treatment in two groups of patients
weight in kilograms
Measured: 4 weeks
BMI changes from baseline after 4 weeks of treatment in two groups of patients
weight and height will be combined to report BMI in kg/m^2
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start18 Sep 2026 (estimated)
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Exocrine Insufficiency, AdulStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07751367
- Sponsor's protocol ID
- KBS20251217
- Status last verified
- Jul 2026
- First submitted
- 20 Jul 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label, Randomized Controlled Trial on the Efficacy and Safety of Different Doses of Oryz-Aspergillus Enzyme And Pancreatin Tablet in Treating Pancreatic Exocrine Insufficiency After Gastrointestinal Surgery
- ClinicalTrials.gov ID
- NCT07751367
- Acronym / sponsor ID
- KBS20251217
- Conditions
- Pancreatic Exocrine Insufficiency, Adul
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 18 Sep 2026 (estimated)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 7 Aug 2026 (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.
This study aims to investigate the efficacy and safety of high-dose Oryz-Aspergillus Enzyme And Pancreatin Tablet in treating postoperative pancreatic exocrine insufficiency (PEI), aiming to fill the gap in evidence-based medicine and promote standardized treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-dose group | Active comparator | Drug: High-dose group: Oryz-Aspergillus Enzyme and Pancreatin TabletOryz-Aspergillus Enzyme And Pancreatin Tablet |
| Low-dose group | Experimental | Drug: Low-dose group: Oryz-Aspergillus Enzyme And Pancreatin TabletOryz-Aspergillus Enzyme And Pancreatin Tablet |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age between 18 and 75 years (inclusive of boundary values), regardless of gender;
- History of prior gastrointestinal surgical treatment, including but not limited to:
- Post-pancreatectomy patients within 3-6 months (e.g., distal pancreatectomy, mid-pancreatectomy, total pancreatectomy, pancreatoduodenectomy); II. Post-gastrectomy patients within 2-6 months (e.g., partial gastrectomy excluding total gastrectomy);
- For tumor patients, the primary tumor stage before or during surgery must be Stage I or II (AJCC 8th edition). Patients in the interval between anti-tumor treatments must have undergone a washout period exceeding 28 days to avoid interference from anti-tumor therapy on this study;
- Diagnosis of pancreatic exocrine insufficiency (PEI) based on comprehensive assessment by the investigator considering medical history, symptoms, nutritional status, and pancreatic function;
Key exclusion criteria (11 listed)
- Known allergy to any component of micafungin pancreatic enzyme tablets;
- Patients with acute pancreatitis or acute exacerbation during active phase of chronic pancreatitis, or those with known contraindications listed in the product label;
- Patients with rare inherited fructose intolerance, glucose-galactose malabsorption, or sucrose-isomaltase deficiency
- Gastrointestinal obstruction;
- Use of other digestive enzyme replacement therapies during the study period;
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 |
|---|---|---|
| High-dose group: Oryz-Aspergillus Enzyme and Pancreatin TabletHigh-dose group: Oryz-Aspergillus Enzyme And Pancreatin Tablet, 5 tablets each time, three times daily, taken with each main meal or after meals, continuous administration for 4 weeks (28 days); | Drug | High-dose group |
| Low-dose group: Oryz-Aspergillus Enzyme And Pancreatin TabletLow-dose group: Oral study drug:Oryz-Aspergillus Enzyme And Pancreatin Tablet, 1 tablet each time, three times daily, taken with each main meal or after meals, continuous administration for 4 weeks (28 days). | Drug | Low-dose group |
Primary outcome
Change in Gastrointestinal Symptom Rating Scale (GSRS) from baseline in the two groups of patients before treatment, after 5 days of treatment, and after 4 weeks of treatment
Time frame: 5 days,4 weeks
Scale Full Name: Gastrointestinal Symptom Rating Scale (GSRS) The total score ranges from 15 (lowest, no symptoms) to 105 (highest, all symptoms extremely severe). Higher scores mean a worse outcome.
8 secondary outcomes
Change in nutritional status scores (NRS 2002 scale) of the two groups of patients after 4 weeks of treatment compared to baseline
Time frame: 4 weeks
Laboratory values after 4 weeks of treatment in the two groups: changes in total protein levels
Time frame: 4 weeks
Laboratory values after 4 weeks of treatment in the two groups: changes in albumin levels
Time frame: 4 weeks
Laboratory values after 4 weeks of treatment in the two groups: changes in globulin levels
Time frame: 4 weeks
Laboratory values after 4 weeks of treatment in the two groups: changes in prealbumin levels
Time frame: 4 weeks
Laboratory values after 4 weeks of treatment in the two groups: changes in transferrin levels
Time frame: 4 weeks
Weight changes from baseline after 4 weeks of treatment in two groups of patients
Time frame: 4 weeks
BMI changes from baseline after 4 weeks of treatment in two groups of patients
Time frame: 4 weeks
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 7 Aug 2026.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-dose group: Oryz-Aspergillus Enzyme and Pancreatin Tablet and Low-dose group: Oryz-Aspergillus Enzyme And Pancreatin Tablet in people with Pancreatic Exocrine Insufficiency, Adul, run by Tianjin Medical University Cancer Institute and 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 8 inclusion and 11 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 7 Aug 2026. 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. 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 Jihui Hao M.D. (022-23524155, ec_tjcih@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Gastrointestinal Symptom Rating Scale (GSRS) from baseline in the two groups of patients before treatment, after 5 days of treatment, and after 4 weeks of treatment (time frame: 5 days,4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Aug 2026.