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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0006172

Enrollment

Registered

2021-05-24

Start date

2021-06-01

Completion date

Unknown

Last updated

2021-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Subjects receive 1 tablet of Nozyme (40,000 IU, Pankreatan

Nordmark Arzneimittel GmbH & Co, Uetersen, Germany) 3 times a day, 30 minutes after meals, for a total of 28 days.

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Effect of Pancreatic Enzyme Supplementation in Patients with Digestive Symptoms After Pancreatic Resection	—

Secondary

Measure	Time frame
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	—

Countries

Korea, Republic of

Contacts

Public ContactIk Hyun Jo

The Catholic University of Korea, St. Vincent's Hospital

jera0131@naver.com+82-31-881-8913

Outcome results