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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03102281
Other study ID # BDS-CN-1702
Secondary ID
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
Health authority
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.

Study Design


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
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