Beneficial Effects of Probiotics on Improvement of Gut Dysbiosis and Ascending Cholangitis in Patients Received Pancreaticoduodenectomy

Not Applicable

Completed

• Conditions: Precancerous Lesions
• Interventions: Dietary Supplement: Yugart

• Registration Number: NCT06126432
• Lead Sponsor: National Cheng-Kung University Hospital

Brief Summary

To determine whether probiotics have beneficial effect on gut dysbiosis and postoperative ascending cholangitis in patients with pancreaticoduodenectomy.

Detailed Description

Gut dysbiosis and postoperative ascending cholangitis (POAC) occurred after pancreaticoduodenectomy (PD). To date, no clinical trial has evaluated the association between gut dysbiosis, POAC and probiotics. POAC is a common morbidity after pancreaticoduodenectomy or in obstructive jaundice patients with endoscopic retrograde biliary drainage (ERBD). It frequently induces longer hospital stay and makes the major obstacle for postoperative chemotherapy. This phenomenon reveals the important role of ampullary vater in control of retrograde bacterial inflow into bile duct. However, the exact difference of gut microbiota after pancreaticoduodenectomy is still unknown. Probiotics is reported efficacy in restore the normal flora of gut microbiota. So, this study is to evaluate the effects of probiotics consumption, Yugart 2 bottles per day for 1 month on gut microbiota in control of ascending cholangitis before and after pancreaticoduodenectomy through the analysis of microbial community by next generation sequencing.

Study Timeline

• Study Start: 2015-03-30
• Primary Completion: 2018-12-31
• Study Completion: 2019-07-31
• Status Verified: 2023-11
• Study First Submitted: 2023-11-06
• Study First Submitted QC: 2023-11-06
• Last Update Submitted: 2023-11-06
• Study First Posted: 2023-11-13
• Last Update Posted: 2023-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Subjects with peri-ampullary lesions and scheduled to receive pancreaticoduodenectomy (PD) were designed as experimental group; subjects with pancreatic lesions and scheduled to receive distal pancreatectomy (DP) were designed as control group.
• Subjects that already received PD for more than 6 months to join the study and aim to evaluate the effect of probiotics on gut microbiota and postoperative ascending cholangitis (POAC).
• Subjects with the amount of two bottles a day (one provided in the morning and the other in the afternoon) for a duration of 4 weeks.

Exclusion Criteria

• Subjects are currently participating in any other clinical trials or studies.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
To evaluate the effects of probiotics consumption	Yugart	Subjects consumed 2 bottles of probiotics-containing yogurt per day for 1 month

Primary Outcome Measures

Name	Time	Method
The effects of probiotics on the postoperative ascending cholangitis	12 weeks	To determine the gut microbiota in control of ascending cholangitis before and after pancreaticoduodenectomy through the analysis of microbial community by next generation sequencing.

Trial Locations

Locations (1)

National Cheng Kung University Hospital; 🇨🇳 Tainan, Taiwan