Clinical Trial: Microbiomes in Patients of Recurrent Common Bile Duct Stones

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Gastrointestinal Microbiomes in Patients of Recurrent Common Bile Duct Stones After Endoscopic Sphincterotomy（EST）

Brief Summary: Bile duct stones is a common biliary tract disease, which is characterized by high morbidity and frequent recurrence. Endoscopic retrograde cholangiopancreatography (ERCP) is an effective therapy for common bile duct stones, and endoscopic sphincterotomy (EST) which associated with recurrent cholangiolithiasis often carried out on difficult intubation or extracting stones, probably due to enhanced reflux of intestinal contents that changes the microenvironment. Patients with cholangiolithiasis were consecutively recruited and their bile was collected intra-operatively for high-throughput experiments. Pyrosequencing of 16S ribosomal RNA gene was performed to characterize the microbiota in the bile and other body fluids. A liquid chromatography mass spectrometry-based method was used to profile bile composition. Clinical manifestation, microbiome, and bile composition were compared between patients with or without recurrent of bile duct stones. The aim of our study was to identify the impact of microbiomes on the recurrent of bile duct stones after ERCP+EST therapy.

Detailed Summary:
Sponsor: The Second Hospital of Nanjing Medical University

Current Primary Outcome: Changes of Bacteria in Body Fluid [ Time Frame: 3 years ]

measure the changes of Bacteria in Body Fluid


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Stone diameter [ Time Frame: 3 years ]
    measure the stone diameter
  • EST size [ Time Frame: 3 years ]
    measure the EST size
  • Stone type [ Time Frame: 3 years ]
    test the stone type
  • Bile acid composition(Mass spectrometry or Chromatography) [ Time Frame: 3 years ]
    measure the bile acid composition with Mass spectrometry or Chromatography


Original Secondary Outcome: Same as current

Information By: The Second Hospital of Nanjing Medical University

Dates:
Date Received: March 8, 2017
Date Started: May 1, 2017
Date Completion: March 31, 2020
Last Updated: March 30, 2017
Last Verified: March 2017