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Specific Carbohydrate Diet for Primary Sclerosing Cholangitis (DINER Trial)

N/A
Waitlist Available
Led By Joshua Korzenik, MD
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up control period (weeks 0-2) to week 14
Awards & highlights

Summary

This trial tests if special diets can help people with a chronic liver disease called PSC by changing their gut bacteria and bile acids. Participants will follow either a specific carbohydrate diet or a vegan/low-sulfur diet for a few months.

Eligible Conditions
  • Primary Sclerosing Cholangitis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~control period (weeks 0-2) to week 14
This trial's timeline: 3 weeks for screening, Varies for treatment, and control period (weeks 0-2) to week 14 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Shannon index
Secondary study objectives
ALP level

Trial Design

2Treatment groups
Experimental Treatment
Group I: Specific Carbohydrate DietExperimental Treatment1 Intervention
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.
Group II: Low-Protein/Vegan/Low-Sulfur DietExperimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalOTHER
2,993 Previous Clinical Trials
13,230,701 Total Patients Enrolled
Brigham and Women's HospitalLead Sponsor
1,653 Previous Clinical Trials
11,491,015 Total Patients Enrolled
University of California, DavisOTHER
928 Previous Clinical Trials
4,720,998 Total Patients Enrolled
~4 spots leftby Sep 2025
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