The Impact of Dietary Constituents on Fecal Microbial and Bile Acid Composition in Patients with Primary Sclerosing Cholangitis

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"To investigate whether there is any association or correlation between PSC patient’s diets, microbiome and bile acids"
Age: 18 years or older
Gender:
Any
Healthy Volunteers: No
Keywords: PSC, Primary Sclerosing Cholangitis, Diet, Nutrition, Microbiome, Bile Acid, Metabolomics
Type: Investigator Initiated Research Study
Target:
60 Participants
Investigator:
Description
This study seeks to determine the correlations between specific dietary constituents and fecal and bile acid composition in patients with primary sclerosing cholangitis. Participants are to complete a three day food log and food frequency questionnaire. After completion of the food log, both a blood and stool sample will be collected.
This study requires

This study requires one medical visit and some medical tests. This includes a blood draw, stool sample collection, and completion of a questionnaire.

If you take part in this research, you will be responsible to:

-Record your diet for three days

-Complete a Food Frequency Questionnaire

-Collect and turn in a stool sample

Who can participate

Inclusion Criteria

• Diagnosis of large duct PSC in accordance with AASLD and EASL guidelines

• Ability to provide informed consent

• 18 years of age or older

Exclusion Criteria

• Other concomitant liver disease including Hepatitis B or C, alcoholic liver disease, or non-alcoholic fatty liver disease

• Decompensated liver disease including the history of ascites, hepatic encephalopathy, or variceal bleeding.

• Current smoking status

• History of liver transplant or current listing for liver transplantation

• History of Colectomy

• Use of antibiotics within 6 months of stool collection

• Current use of immunomodulators including corticosteroids, azathioprine, 6-mercaptopurine, mycophenolate mofetil, tacrolimus, or biologics including anti-TNF and anti-integrin therapies

• Prisoners

• Pregnant women or women who are breastfeeding

• Cognitively impaired individuals or inability to provide informed consent

• Other vulnerable patient populations who are unable to consent

Benefits and risks of participating
Benefits:
Participating in this study will not have any direct benefits beyond your normal care. However, your participation will contribute to research that may help others with PSC in the future.

Risks:
The risks for this study are minimal, foreseeable risks will vary depending upon the types of samples collected. Blood collection may cause bruising or stinging at the site of venipuncture. We do not foresee any risks in submitting stool samples.
There may also be risks to your privacy. The researchers will store study records and other information about you in a secure location and will grant access only to the investigator and his research staff.
Compensation
There is no compensation for participating in this research study.
Resources
Schedule
Study duration and period
One week
Recruitment period
From May 7, 2018 to May 7, 2019
Location
UC Davis Liver Research
2000 Stockton Boulevard
Suite# 100B
Sacramento, CA 95817

Have any questions or want to learn more? Leave your contact details below and the research team will reach out to you.


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