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Microbiomes in Patients of Recurrent Common Bile Duct Stones

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03102281
Enrollment
100
Registered
2017-04-05
Start date
2017-05-01
Completion date
2020-03-31
Last updated
2017-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Choledocholithiasis, Cholelithiasis

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.

Interventions

None listed

Sponsors

The Second Hospital of Nanjing Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Changes of Bacteria in Body Fluid3 yearsmeasure the changes of Bacteria in Body Fluid

Secondary

MeasureTime frameDescription
Stone diameter3 yearsmeasure the stone diameter
EST size3 yearsmeasure the EST size
Stone type3 yearstest the stone type
Bile acid composition(Mass spectrometry or Chromatography)3 yearsmeasure the bile acid composition with Mass spectrometry or Chromatography

Countries

China

Contacts

Primary ContactMiao Lin
miaolinxh@163.com086-25-58509932

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026