Microbiomes in Patients of Recurrent Common Bile Duct Stones

• Conditions: Cholelithiasis; Choledocholithiasis

• Registration Number: NCT03102281
• Lead Sponsor: The Second Hospital of Nanjing Medical University

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 Description

Not available

Study Timeline

• Status Verified: 2017-03
• Study First Submitted: 2017-03-08
• Study First Submitted QC: 2017-03-30
• Last Update Submitted: 2017-03-30
• Study First Posted: 2017-04-05
• Last Update Posted: 2017-04-05
• Study Start: 2017-05-01
• Primary Completion: 2020-03-31
• Study Completion: 2020-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Patients with recurrent common bile duct stones.
2. No antibiotics or probiotics are used for nearly three months.
3. In addition to common bile duct stones, possibly without other digestive diseases.

Exclusion Criteria

1. Significant neurological or psychiatric disorders (psychotic disorders, dementia or seizures) that would prohibit the understanding and giving of informed consent.
2. Pregnant or lactating females.
3. Active Hepatitis B or C or history of an HIV infection.
4. Active uncontrolled infection.
5. Billroth II or roux-en Y gastrointestinal alteration people.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes of Bacteria in Body Fluid	3 years	measure the changes of Bacteria in Body Fluid

Secondary Outcome Measures

Name	Time	Method
Stone diameter	3 years	measure the stone diameter
Bile acid composition(Mass spectrometry or Chromatography)	3 years	measure the bile acid composition with Mass spectrometry or Chromatography
EST size	3 years	measure the EST size
Stone type	3 years	test the stone type

Trial Locations

Locations (1)

Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China