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A Pilot Study Examining Diet in 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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ control period (weeks 0-2) to week 14

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

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