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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

DINER Trial Summary

This study is evaluating whether a specific diet may help reduce symptoms of PSC.

Eligible Conditions
  • Primary Sclerosing Cholangitis

DINER Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Shannon index
Secondary outcome measures
ALP level

DINER 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
2,952 Previous Clinical Trials
13,211,590 Total Patients Enrolled
Brigham and Women's HospitalLead Sponsor
1,626 Previous Clinical Trials
11,473,602 Total Patients Enrolled
University of California, DavisOTHER
916 Previous Clinical Trials
4,720,780 Total Patients Enrolled
~4 spots leftby Jun 2025
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