Microbiomes in Patients of Recurrent Common Bile Duct Stones

NCT03102281 | Unknown DMC

• 1 other identifier: BDS-CN-1702
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Cholelithiasis; Choledocholithiasis

Outcome Measures

Primary Outcomes (1)

• Changes of Bacteria in Body Fluid

  measure the changes of Bacteria in Body Fluid

  3 years

Secondary Outcomes (4)

• Stone diameter

  3 years

• EST size

  3 years

• Stone type

  3 years

• Bile acid composition(Mass spectrometry or Chromatography)

  3 years

Study Arms (2)

recurrent group

Patients who had recurrent common bile duct stones.

control group

Patients who had not recurrent common bile duct stones.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects will be adults with recurrent common bile duct stones.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Second Hospital of Nanjing Medical University: lead

Study Sites (1)

Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210011, China

RECRUITING

MeSH Terms

Conditions

Cholelithiasis; Choledocholithiasis

Condition Hierarchy (Ancestors)

Biliary Tract Diseases; Digestive System Diseases; Common Bile Duct Diseases; Bile Duct Diseases

Study Officials

• Miao Lin, Study Principal Investigator

  Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Miao Lin

CONTACT

086-25-58509932; miaolinxh@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2017
• First Posted: April 5, 2017
• Study Start: May 1, 2017
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2020
• Last Updated: April 5, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)