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

Sponsor

National Cheng-Kung University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT06126432

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Precancerous Lesions	Dietary Supplement: Yugart	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Single intervention arm with trial treatmentSingle intervention arm with trial treatment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

National Cheng Kung University Hospital

Actual Study Start Date :

Mar 30, 2015

Actual Primary Completion Date :

Dec 31, 2018

Actual Study Completion Date :

Jul 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: To evaluate the effects of probiotics consumption Subjects consumed 2 bottles of probiotics-containing yogurt per day for 1 month	Dietary Supplement: Yugart Yugart 2 bottles per day for 1 month

Arm

Intervention/Treatment

Experimental: To evaluate the effects of probiotics consumption

Subjects consumed 2 bottles of probiotics-containing yogurt per day for 1 month

Dietary Supplement: Yugart

Yugart 2 bottles per day for 1 month

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 120 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Cheng Kung University Hospital	Tainan		Taiwan	704

Sponsors and Collaborators

National Cheng-Kung University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

National Cheng-Kung University Hospital

ClinicalTrials.gov Identifier:

NCT06126432

Other Study ID Numbers:

B-ER-103-318

First Posted:

Nov 13, 2023

Last Update Posted:

Nov 13, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by National Cheng-Kung University Hospital

Ampullary

Pancreas

Study Results

No Results Posted as of Nov 13, 2023