A Pilot Study Examining Diet in Primary Sclerosing Cholangitis

NCT04678219 | Completed

• 1 other identifier: 2019P002075
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Primary Sclerosing Cholangitis

Keywords

Primary Sclerosing Cholangitis; Diet; Specific Carbohydrate Diet; Low-Protein; Low-Sulfur; Vegan

Outcome Measures

Primary Outcomes (1)

• Shannon index

  The primary endpoint will be the within group change in the Shannon diversity index. The Shannon diversity index is used to characterize species diversity in a community (the diversity in the fecal microbiome).

  Control period (Weeks 0-2) to Week 14

Secondary Outcomes (1)

• ALP level

  Control period (Weeks 0-2) to Week 14

Study Arms (2)

Low-Protein/Vegan/Low-Sulfur Diet

EXPERIMENTAL

This is a specific diet that is both vegan and low in protein. The vegan diet eliminates all animal products, (including meats, eggs, dairy products) and animal by-products such as honey.

Other: Dietary Intervention

Specific Carbohydrate Diet

EXPERIMENTAL

The Specific Carbohydrate Diet emphasizes consumption of specific carbohydrates that require minimal digestion. Therefore, it eliminates most carbohydrates, including grains, starches, dairy and sugars. The idea behind this diet is that it reshapes the microbiome of the intestines. The diet restricts the intake of certain carbohydrates that may increase the growth of "bad" bacteria possibly contributing to inflammation. By restricting the amount of these carbohydrates in the microbiome, the diet aims to reduce their activity in the gut and reduce inflammation.

Other: Dietary Intervention

Interventions

Dietary Intervention OTHER

Subjects will be placed on 1 of 2 diets for a treatment period of 8 weeks with the support of dietitians; it will then be evaluated whether they can continue this diet on their own for 4 weeks.

Low-Protein/Vegan/Low-Sulfur Diet; Specific Carbohydrate Diet

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• University of California, Davis: collaborator
• Massachusetts General Hospital: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Cholangitis, Sclerosing

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Cholangitis; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• Joshua Korzenik, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Crohn's and Colitis Center

Model Details: 20 subjects will be randomized onto either the Specific Carbohydrate Diet or the low-protein (vegan/low-sulfur) diet, with 10 subjects per diet.

Study Record Dates

• First Submitted: August 18, 2020
• First Posted: December 21, 2020
• Study Start: August 28, 2020
• Primary Completion: August 1, 2021
• Study Completion: December 1, 2021
• Last Updated: March 12, 2026

Record last verified: 2026-03

Locations

US (1)