Microbiomes in Patients of Recurrent Common Bile Duct Stones

Study Overview
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Brief Summary
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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.

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

Conditions
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Cholelithiasis, Choledocholithiasis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with recurrent common bile duct stones. No antibiotics or probiotics are used for nearly three months. In addition to common bile duct stones, possibly without other digestive diseases. Exclusion Criteria: Significant neurological or psychiatric disorders (psychotic disorders, dementia or seizures) that would prohibit the understanding and giving of informed consent. Pregnant or lactating females. Active Hepatitis B or C or history of an HIV infection. Active uncontrolled infection. Billroth II or roux-en Y gastrointestinal alteration people.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| recurrent group<br>Patients who had recurrent common bile duct stones. | |
| control group<br>Patients who had not recurrent common bile duct stones. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of Bacteria in Body Fluid | measure the changes of Bacteria in Body Fluid | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stone diameter | measure the stone diameter | 3 years | 
| EST size | measure the EST size | 3 years | 
| Stone type | test the stone type | 3 years | 
| Bile acid composition(Mass spectrometry or Chromatography) | measure the bile acid composition with Mass spectrometry or Chromatography | 3 years |