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OpenTrials
Completed

NCT Number: NCT06126432

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

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

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Key information

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Cheng Kung University Hospital

Tainan, 704, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Yugart

Dietary Supplement

Yugart 2 bottles per day for 1 month

Primary outcomes

  1. The effects of probiotics on the postoperative ascending cholangitis

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

National Cheng-Kung University Hospital

Other

Registry information

Official study title

National Cheng Kung University Hospital

Important dates

Study start
2015
Primary completion
2018
Study completion
2019
First posted
Nov 13, 2023
Registry last updated
Nov 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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