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A Pilot Study Examining Diet in Primary Sclerosing Cholangitis (DINER)

Primary Purpose

Primary Sclerosing Cholangitis

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Dietary Intervention

About this trial

This is an interventional treatment trial for Primary Sclerosing Cholangitis focused on measuring Primary Sclerosing Cholangitis, Diet, Specific Carbohydrate Diet, Low-Protein, Low-Sulfur, Vegan

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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.
History of malignancy within 5 years except for adequately treated carcinoma in situ of the cervix and basal or squamous cell carcinoma.
Concurrent participation in another therapeutic clinical trial
Celiac disease
Any laboratory abnormality or condition which in the opinion of the investigator could adversely affect the safety of the participant or impair the assessment of the study results

Sites / Locations

Brigham and Women's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Low-Protein/Vegan/Low-Sulfur Diet

Specific Carbohydrate Diet

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

ALP level

The investigators will be evaluating the trend of alkaline phosphatase reduction (U/L).

Full Information

NCT ID

NCT04678219

First Posted

August 18, 2020

Last Updated

December 16, 2020

Sponsor

Brigham and Women's Hospital

Collaborators

University of California, Davis, Massachusetts General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04678219

Brief Title

A Pilot Study Examining Diet in Primary Sclerosing Cholangitis

Acronym

DINER

Official Title

A Pilot Study Examining a Vegan/Low-Sulfur Diet Versus the Specific Carbohydrate Diet in Patients With Primary Sclerosing Cholangitis

Study Type

Interventional

2. Study Status

Record Verification Date

December 2020

Overall Recruitment Status

Unknown status

Study Start Date

August 28, 2020 (Actual)

Primary Completion Date

August 2021 (Anticipated)

Study Completion Date

December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Brigham and Women's Hospital

Collaborators

University of California, Davis, Massachusetts General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

Detailed Description

The chronic, autoimmune liver disease Primary Sclerosing Cholangitis (PSC) is a progressive cholestatic, hepatobiliary disease characterized by inflammation and fibrosis of the bile duct. As the disease progresses, it may result in debilitating bile duct cirrhosis, malignancy, and liver failure. Although the list of drugs studied for the treatment of PSC is extensive, the main, and commonly only, treatment option remains liver transplantation. Dietary manipulation is an approach of high interest to patients. Presumably, diet may have some influence on the intestinal microbiome and have a modifying impact on the diseases but this has not been well established. The investigators propose a study period of approximately 14 weeks to evaluate the effects of the SCD and vegan/low-sulfur diet on the intestinal microbiome and bile acid composition in stool and serum. Patients will visit their study site or participate in a video visit 7 times over the course of the study. At the screening visit (Week 0), eligibility will be assessed, lab tests will be performed, and subjects will be randomized to dietary instruction on one of the two diets with educational materials, recipes, and food procurement stipend provided. Consent will be signed at or before the screening visit either in-person or remotely. Patients will be asked to collect a stool sample and complete a Food Frequency Questionnaire (FFQ). The treatment phase of 8 weeks will begin at the baseline visit (Week 2). At each of the four time points during the treatment phase (Week 4, 6, 8, 10), participants will record in real-time what they eat by a smartphone app for 3-days, one of which includes a weekend. To enhance compliance to the intervention protocol, the dedicated study coordinator along with the Registered Dietitian will review the food diary data in real-time and discuss any challenges to comply with the meal intervention. After the 8-week treatment period is complete, patients will be encouraged to continue with their diet, self-directed, for 4 weeks following the end of the treatment phase (Week 10). Subjects will be asked to return for one final visit at Week 14 to complete a 3-day food diary and have labs drawn.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Primary Sclerosing Cholangitis

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

None (Open Label)

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Low-Protein/Vegan/Low-Sulfur Diet

Arm Type

Experimental

Arm Description

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.

Arm Title

Specific Carbohydrate Diet

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Dietary Intervention

Intervention Description

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.

Primary Outcome Measure Information:

Title

Shannon index

Description

Time Frame

Control period (Weeks 0-2) to Week 14

Secondary Outcome Measure Information:

Title

ALP level

Description

The investigators will be evaluating the trend of alkaline phosphatase reduction (U/L).

Time Frame

Control period (Weeks 0-2) to Week 14

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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. History of malignancy within 5 years except for adequately treated carcinoma in situ of the cervix and basal or squamous cell carcinoma. Concurrent participation in another therapeutic clinical trial Celiac disease Any laboratory abnormality or condition which in the opinion of the investigator could adversely affect the safety of the participant or impair the assessment of the study results

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Nadine Javier

Phone

617-732-9481

njavier@bwh.harvard.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Gila Sasson, MD

Phone

617-732-9481

gsasson@bwh.harvard.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joshua Korzenik, MD

Organizational Affiliation

Brigham and Women's Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Brigham and Women's Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nadine Javier

Phone

617-732-9481

njavier@bwh.harvard.edu

First Name & Middle Initial & Last Name & Degree

Fernanda Quevedo

Phone

617-732-9173

sfernandaquevedo@bwh.harvard.edu

First Name & Middle Initial & Last Name & Degree

Joshua Korzenik, MD

12. IPD Sharing Statement

Learn more about this trial

A Pilot Study Examining Diet in Primary Sclerosing Cholangitis

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