NCT07751367尚未招募不适用
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
Tianjin Medical University Cancer Institute and Hospital1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2026年9月18日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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;
- •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.
研究组 & 干预措施
High-dose group
Active Comparator
Oryz-Aspergillus Enzyme And Pancreatin Tablet
干预措施: High-dose group: Oryz-Aspergillus Enzyme and Pancreatin Tablet (Drug)
Low-dose group
Experimental
Oryz-Aspergillus Enzyme And Pancreatin Tablet
干预措施: Low-dose group: Oryz-Aspergillus Enzyme And Pancreatin Tablet (Drug)
结局指标
主要结局
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
时间窗: 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.
次要结局
- Laboratory values after 4 weeks of treatment in the two groups: changes in albumin levels(4 weeks)
- 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 globulin levels(4 weeks)
- Laboratory values after 4 weeks of treatment in the two groups: changes in prealbumin levels(4 weeks)
- Laboratory values after 4 weeks of treatment in the two groups: changes in transferrin levels(4 weeks)
- Weight changes from baseline after 4 weeks of treatment in two groups of patients(4 weeks)
- BMI changes from baseline after 4 weeks of treatment in two groups of patients(4 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
尚未招募
不适用
A Prospective, Single-centre, Observational Cohort Study on the Efficacy and Safety of Bacterial Lysate (OM-85) in Combination With Antihistamines for the Treatment of Chronic Spontaneous Urticaria (CSU)NCT07557888The Fourth Affiliated Hospital of Zhejiang University School of Medicine132
尚未招募
不适用
Testing the Effect of a Skincare Product on Melasma in Healthy IndividualsCTRI/2024/12/078257Glenmark Pharmaceuticals Ltd.36
招募中
4 期
Comparison of inhalational new drug vilanterol fluticasone furoate combination with salmeterol fluticasone furoate combination for reversible respiratory obstructive disease.CTRI/2024/04/066334Central Research And Publication Unit70
招募中
不适用
Cease Chronic Kidney DiseaseCTRI/2025/07/092042210
尚未招募
不适用
Study to Check Safety and Effectiveness of Skin Care ProductsCTRI/2025/09/095326ClayCo. Cosmetics Pvt. Ltd.33