A Pilot Study Examining Diet in Primary Sclerosing Cholangitis (NCT04678219) | Clinical Trial Compass
CompletedNot Applicable
A Pilot Study Examining Diet in Primary Sclerosing Cholangitis
United States20 participantsStarted 2020-08-28
Plain-language 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 8 weeks; the entire study will last approximately 14 weeks. Participants will work with BWH Registered Dieticians and receive dietary educational materials, recipes, and a food procurement stipend to support the new diet. Subjects will attend 7 video visits and have regular lab tests performed, requiring blood and stool samples.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. 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
✕. 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