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A Pilot Study Examining Diet in Primary Sclerosing Cholangitis

NCT04678219 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-03-12

No results posted yet for this study

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

Interventions

OTHER

Dietary Intervention

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.

Sponsors & Collaborators

  • University of California, Davis

    collaborator OTHER

  • Massachusetts General Hospital

    collaborator OTHER

  • Brigham and Women's Hospital

    lead OTHER

Principal Investigators

  • Joshua Korzenik, MD · Brigham and Women's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-28
Primary Completion
2021-08-01
Completion
2021-12-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04678219 on ClinicalTrials.gov