Primary Sclerosing CholangitisDINERNCT04678219
A Pilot Study Examining Diet in Primary Sclerosing Cholangitis
A study testing Dietary Intervention in people with Primary Sclerosing Cholangitis, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Primary Sclerosing Cholangitis
- What is being tested?
- Dietary Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Aug 2020to 1 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: A Pilot Study Examining a Vegan/Low-Sulfur Diet Versus the Specific Carbohydrate Diet in Patients With Primary Sclerosing Cholangitis
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.
Read the 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.
- Conditions
- Primary Sclerosing Cholangitis
- Being tested
- Dietary Intervention
- Keywords
- Primary Sclerosing Cholangitis, Diet, Specific Carbohydrate Diet, Low-Protein, Low-Sulfur, Vegan
- Medical subject headings
- Cholangitis, Sclerosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary InterventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Low-Protein/Vegan/Low-Sulfur Diet | Experimental | 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. Receives: Other: Dietary Intervention |
| Specific Carbohydrate Diet | Experimental | 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. Receives: Other: Dietary Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Control period (Weeks 0-2) to Week 14
Secondary outcomes (1)
ALP level
The investigators will be evaluating the trend of alkaline phosphatase reduction (U/L).
Measured: Control period (Weeks 0-2) to Week 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2020
- Study start28 Aug 2020
- Primary completion1 Aug 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Sclerosing CholangitisStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Davis, Massachusetts General Hospital
- Responsible party
- Principal investigator, Joshua Korzenik, Brigham and Women's Hospital
- Investigators
- Joshua Korzenik, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04678219
- Sponsor's protocol ID
- 2019P002075
- Acronym
- DINER
- Status last verified
- Mar 2026
- First submitted
- 18 Aug 2020
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Examining a Vegan/Low-Sulfur Diet Versus the Specific Carbohydrate Diet in Patients With Primary Sclerosing Cholangitis
- ClinicalTrials.gov ID
- NCT04678219
- Acronym / sponsor ID
- DINER / 2019P002075
- Conditions
- Primary Sclerosing Cholangitis
- Keywords
- Primary Sclerosing Cholangitis, Diet, Specific Carbohydrate Diet, Low-Protein, Low-Sulfur, Vegan
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- University of California, Davis, Massachusetts General Hospital
- Study start
- 28 Aug 2020 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 21 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Low-Protein/Vegan/Low-Sulfur Diet | Experimental | Other: Dietary InterventionThis 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. |
| Specific Carbohydrate Diet | Experimental | Other: Dietary InterventionThe 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary InterventionSubjects 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. | Other | Low-Protein/Vegan/Low-Sulfur Diet, Specific Carbohydrate Diet |
Primary outcome
Shannon index
Time frame: Control period (Weeks 0-2) to Week 14
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).
1 secondary outcome
ALP level
Time frame: Control period (Weeks 0-2) to Week 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joshua Korzenik, MD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Intervention in people with Primary Sclerosing Cholangitis, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shannon index (time frame: Control period (Weeks 0-2) to Week 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.