The efficacy of the pancreatic enzyme replacement on small intestinal bacterial overgrowth in patients with pancreatectomy: A prospective, single-arm clinical trial

Not Applicable

• Conditions: Neoplasms

• Registration Number: KCT0006172
• Lead Sponsor: The Catholic University of Korea, St. Vincent's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 June 2021

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 69

Inclusion Criteria

Patients who underwent pancreatic resection for pancreatic lesions and were diagnosed with a cure for at least 6 months by pathology and were accompanied by one or more of the following symptoms of the digestive system: abdominal pain, abdominal discomfort, abdominal distension, diarrhea, fatty stool, nausea, and vomiting.

Exclusion Criteria

A. Those who received antibiotics within 3 months
B. Patients currently undergoing chemotherapy
C. Patients with tumor recurrence, stenosis, or organic obstruction by gastrointestinal endoscopy or gastrointestinal angiography
D. Patients who had gastrointestinal surgery (except appendectomy and gallbladder surgery)
E. Have a digestive disorder (e.g., gastric ulcer, duodenal ulcer, esophageal cancer, gastric cancer, small enteritis, colitis, etc.) that may affect the exercise evaluation of the digestive system within the last 15 days
F. Those with diseases that have a significant impact on this study (E.g., renal failure of 3.0 mg/dL or more of creatinine in the blood, liver disease corresponding to Child-Pugh classification C)
G. In the case of taking drugs, such as narcotic drugs, probiotics, laxatives, etc., that may affect the exercise evaluation of the digestive system (except for those who have a drug holiday of 7 days or more)
H. Pregnant/nursing women (when registering women of childbearing age, check pregnancy test)
I. When communication is difficult due to hearing impairment
J. Patients currently participating in other research trials
K. Others, the person in charge of the research test or the person in charge determines that it is inappropriate

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Effect of Pancreatic Enzyme Supplementation in Patients with Digestive Symptoms After Pancreatic Resection

Secondary Outcome Measures

Name	Time	Method
The Prevalence of Small Intestinal Bacterial Overgrowth in Patients with Digestive Symptoms After Pancreatic Resection;The Prevalence of Pancreas Insufficiency in Patients with Digestive Symptoms After Pancreatic Resection;The Association between Small Intestinal Bacterial Overgrowth and Pancreatic Insufficiency in Patients with Digestive Symptoms After Pancreatic Resection