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Microbiomes in Patients of Recurrent Common Bile Duct Stones

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ClinicalTrials.gov Identifier: NCT03102281
Recruitment Status : Recruiting
First Posted : April 5, 2017
Last Update Posted : April 5, 2017
Sponsor:
Information provided by (Responsible Party):
The Second Hospital of Nanjing Medical University

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.

Condition or disease
Cholelithiasis Choledocholithiasis

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Gastrointestinal Microbiomes in Patients of Recurrent Common Bile Duct Stones After Endoscopic Sphincterotomy(EST)
Estimated Study Start Date : May 1, 2017
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : March 31, 2020

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



Primary Outcome Measures :
  1. Changes of Bacteria in Body Fluid [ Time Frame: 3 years ]
    measure the changes of Bacteria in Body Fluid


Secondary Outcome Measures :
  1. Stone diameter [ Time Frame: 3 years ]
    measure the stone diameter

  2. EST size [ Time Frame: 3 years ]
    measure the EST size

  3. Stone type [ Time Frame: 3 years ]
    test the stone type

  4. Bile acid composition(Mass spectrometry or Chromatography) [ Time Frame: 3 years ]
    measure the bile acid composition with Mass spectrometry or Chromatography



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects will be adults with recurrent common bile duct stones.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03102281


Contacts
Contact: Miao Lin 086-25-58509932 miaolinxh@163.com

Locations
China, Jiangsu
Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University Recruiting
Nanjing, Jiangsu, China, 210011
Contact: Lin Miao, MD    086-25-58509932    miaolinxh@163.com   
Sponsors and Collaborators
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

Responsible Party: The Second Hospital of Nanjing Medical University
ClinicalTrials.gov Identifier: NCT03102281     History of Changes
Other Study ID Numbers: BDS-CN-1702
First Posted: April 5, 2017    Key Record Dates
Last Update Posted: April 5, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Cholelithiasis
Cholecystolithiasis
Gallstones
Choledocholithiasis
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Calculi
Pathological Conditions, Anatomical
Common Bile Duct Diseases
Bile Duct Diseases