Microbiomes in Patients of Recurrent Common Bile Duct Stones

Cholelithiasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03102281
• Other study ID #: BDS-CN-1702
• Status: Recruiting
• Phase: N/A
• First received: March 8, 2017
• Last updated: March 30, 2017
• Start date: May 1, 2017
• Est. completion date: March 31, 2020

Study information

• Verified date: March 2017
• Source: The Second Hospital of Nanjing Medical University
• Contact: Miao Lin
• Phone: 086-25-58509932
• Email: miaolinxh[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 31, 2020
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cholecystolithiasis
• Choledocholithiasis
• Cholelithiasis
• Gallstones

Locations

Country	Name	City	State
China	Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The Second Hospital of Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of Bacteria in Body Fluid	measure the changes of Bacteria in Body Fluid	3 years
Secondary	Stone diameter	measure the stone diameter	3 years
Secondary	EST size	measure the EST size	3 years
Secondary	Stone type	test the stone type	3 years
Secondary	Bile acid composition(Mass spectrometry or Chromatography)	measure the bile acid composition with Mass spectrometry or Chromatography	3 years