Precancerous Lesions
Conditions
Keywords
Ampullary, Pancreas
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.
Interventions
DIETARY_SUPPLEMENTYugart
Yugart 2 bottles per day for 1 month
Sponsors
National Cheng-Kung University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single intervention arm with trial treatment
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Taiwan
Outcome results
None listed