Status:
UNKNOWN
A Pilot Study Examining Diet in Primary Sclerosing Cholangitis
Lead Sponsor:
Brigham and Women's Hospital
Collaborating Sponsors:
University of California, Davis
Massachusetts General Hospital
Conditions:
Primary Sclerosing Cholangitis
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
This research study is exploring the effects of dietary intervention in PSC. Study participants will be randomly assigned to either the Specific Carbohydrate Diet (SCD) or a vegan/low-sulfur diet for ...
Detailed Description
The chronic, autoimmune liver disease Primary Sclerosing Cholangitis (PSC) is a progressive cholestatic, hepatobiliary disease characterized by inflammation and fibrosis of the bile duct. As the disea...
Eligibility Criteria
Inclusion
- Males and females between 18 and 70 years of age, inclusive based on the date of the screening visit
- Willing and able to give informed consent prior to any study specific procedures being performed
- Diagnosis of PSC documented by typical cholangiogram findings with no evidence of a secondary cause of sclerosing cholangitis
- Serum alkaline phosphatase greater than 1.5 times the upper limit of the normal (ULN) reference range
- Simple clinical colitis activity index \< 5
- For subjects on UDCA, the dose of UDCA must have been stable for at least 3 months before screening. For subjects not on UDCA, no UDCA use for at least 3 months before screening.
- Platelet count \> 150,000/mm3
- Albumin \> 3.3 g/dL
- Serum creatinine \< ULN
- Willing and able to comply with scheduled visits, laboratory tests, stool collection, and other study procedures including to follow a vegan/low-sulfur diet or SCD for the duration of the trial regardless of treatment arm randomization
- Able to read English and complete PSC PRO independently
Exclusion
- Pregnant or lactating females
- ALT \> 10 x ULN
- Total bilirubin \> 2 X ULN
- INR \> 1.2
- Decompensated cirrhosis defined by ascites, hepatic encephalopathy, or variceal bleeding
- Small duct PSC
- Other causes of liver disease including secondary sclerosing cholangitis, viral, metabolic, alcoholic, and other autoimmune liver diseases. Subjects with non-alcoholic fatty liver disease may be included if there is no evidence of NASH in the opinion of the investigator
- Positive AMA
- History of liver transplantation
- History of hepatocellular carcinoma or cholangiocarcinoma
- Ascending cholangitis within 90 days of enrollment
- Any antibiotic use within 90 days of enrollment or planned antibiotic use during the study period
- Current vegetarian or adherence to the SCD
- Nut allergy (Many of the recipes included in the specific carbohydrate diet substitute nut flour for wheat flour. Subjects randomized to either the specific carbohydrate diet arm will have difficulty with dietary adherence as they will be intolerant of this dietary staple).
- Inability to complete dietary log.
- History of malignancy within 5 years except for adequately treated carcinoma in situ of the cervix and basal or squamous cell carcinoma.
- Concurrent participation in another therapeutic clinical trial
- Celiac disease
- Any laboratory abnormality or condition which in the opinion of the investigator could adversely affect the safety of the participant or impair the assessment of the study results
Key Trial Info
Start Date :
August 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04678219
Start Date
August 28 2020
End Date
December 1 2021
Last Update
December 21 2020
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115