Microbiomes in Patients of Recurrent Common Bile Duct Stones

NCT ID: NCT03102281

Last Updated: 2017-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-01

Study Completion Date

2020-03-31

Brief Summary

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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

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Conditions

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Cholelithiasis Choledocholithiasis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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recurrent group

Patients who had recurrent common bile duct stones.

No interventions assigned to this group

control group

Patients who had not recurrent common bile duct stones.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Second Hospital of Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Miao Lin, Study Principal Investigator

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Miao Lin

Role: CONTACT

086-25-58509932

Facility Contacts

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Lin Miao, MD

Role: primary

086-25-58509932

Other Identifiers

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BDS-CN-1702

Identifier Type: -

Identifier Source: org_study_id

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