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OpenTrials
Completed

NCT Number: NCT03590886

Gut Microbes and Metabolic Group in Different PBC Patients for UDCA Response

To compare intestinal flora diversity in different PBC patients with UDCA responses, and further study the differences of bile acid metabolism and short chain fatty acid metabolism in feces and serum of two groups of PBC patients.

Completed

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Key information

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510630, China

About this study

The PBC patients have been enrolled in the study for UDCA treatment more than 1 year, who is divided into the UDCA total response Group and the other poor response group according to Paris-I/II standard .The feces of two groups of patients were collected and the differences of microbial polymorphism of fecal microorganism in two groups were observed. The metabolic differences of bile acids and short chain fatty acids in serum and feces of two groups of PBC patients were studied by means of metabolic proteomics.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

1.Confirmed diagnostic criteria about PBC, and orally UDCA treatment for more than a year; 2.30-70 years old; 3.Currently only UDCA therapy, not glucocorticoids and immunosuppressor treatment.

Exclusion criteria

  • Viral liver disease;
  • alcoholic liver disease;
  • fatty liver;
  • drug-associated liver damage;
  • infectious disease;
  • obesity;
  • gastrointestinal diseases;
  • combined with other autoimmune diseases;
  • cardiac and pulmonary dysfunction;
  • renal dysfunction, malignant tumor,;
  • neurological and psychiatric abnormalities;
  • nearly 2 months to take antibiotics and probiotics;
  • nearly 3 months participate in other drug clinical trials .

Treatment and study plan

total response Group

Other

biochemical response for UDCA treatment more than 1 year according to Paris-I/II standard

Other names: poor response group

Primary outcomes

  1. fecal microbial diversity

    Time frame: 6 months

    Macrogenomic examination of fecal microbial DNA

Secondary outcomes

  1. bile acid metabolites

    Time frame: 6 months

    The examination of bile acid metabolites by ELISA methods

  2. short chain fatty acid metabolites

    Time frame: 6 months

    The examination of short chain fatty metabolites by ELISA methods

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

A Clinical Study About Gut Microbes and Metabolic Group in Different PBC Patients for UDCA Response

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Jul 18, 2018
Registry last updated
Dec 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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