A Study on the Efficacy of Different Doses of Oryz-Aspergillus Enzyme And Pancreatin Tablet in Treating Pancreatic Exocrine Insufficiency After Gastrointestinal Surgery

NCT07751367 | Not Yet Recruiting

• 1 other identifier: KBS20251217
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pancreatic Exocrine Insufficiency, Adul

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  4 weeks

• Laboratory values after 4 weeks of treatment in the two groups: changes in total protein levels

  4 weeks

• Laboratory values after 4 weeks of treatment in the two groups: changes in albumin levels

  4 weeks

• Laboratory values after 4 weeks of treatment in the two groups: changes in globulin levels

  4 weeks

• Laboratory values after 4 weeks of treatment in the two groups: changes in prealbumin levels

  4 weeks

Study Arms (2)

High-dose group

ACTIVE COMPARATOR

Oryz-Aspergillus Enzyme And Pancreatin Tablet

Drug: High-dose group: Oryz-Aspergillus Enzyme and Pancreatin Tablet

Low-dose group

EXPERIMENTAL

Oryz-Aspergillus Enzyme And Pancreatin Tablet

Drug: Low-dose group: Oryz-Aspergillus Enzyme And Pancreatin Tablet

Interventions

High-dose group: Oryz-Aspergillus Enzyme and Pancreatin Tablet DRUG

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);

High-dose group

Low-dose group: Oryz-Aspergillus Enzyme And Pancreatin Tablet DRUG

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).

Low-dose group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 75 years (inclusive of boundary values), regardless of gender;
• History of prior gastrointestinal surgical treatment, including but not limited to:
• I. 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300000, China

Location

MeSH Terms

Conditions

Exocrine Pancreatic Insufficiency

Interventions

Pancreatin

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Hydrolases; Enzymes; Enzymes and Coenzymes; Pancreatic Extracts; Tissue Extracts; Complex Mixtures

Central Study Contacts

Jihui Hao M.D.

CONTACT

022-23524155; ec_tjcih@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2026
• First Posted: August 7, 2026
• Study Start (Estimated): September 18, 2026
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: August 7, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)