Microbiomes in Patients of Recurrent Common Bile Duct Stones

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

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.

Study Overview

• Status: Unknown
• Conditions: Cholelithiasis; Choledocholithiasis

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Miao Lin; Phone Number: 086-25-58509932; Email: miaolinxh@163.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210011
      • Recruiting
      • Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects will be adults with recurrent common bile duct stones.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
recurrent group; Patients who had recurrent common bile duct stones.
control group; Patients who had not recurrent common bile duct stones.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The Second Hospital of Nanjing Medical University
• Investigators: Principal Investigator: Miao Lin, Study Principal Investigator, Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2017
• Primary Completion (Anticipated): March 31, 2020
• Study Completion (Anticipated): March 31, 2020

Study Registration Dates

• First Submitted: March 8, 2017
• First Submitted That Met QC Criteria: March 30, 2017
• First Posted (Actual): April 5, 2017

Study Record Updates

• Last Update Posted (Actual): April 5, 2017
• Last Update Submitted That Met QC Criteria: March 30, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathological Conditions, Anatomical; Gallbladder Diseases; Biliary Tract Diseases; Bile Duct Diseases; Common Bile Duct Diseases; Calculi; Gallstones; Cholelithiasis; Cholecystolithiasis; Choledocholithiasis
• Other Study ID Numbers: BDS-CN-1702

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No