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Can a special diet help PSC patients? small study tests two options

NCT ID NCT04678219

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This pilot study looked at how two different diets affect people with primary sclerosing cholangitis (PSC), a rare liver disease. Twenty adults were randomly assigned to either a vegan/low-sulfur diet or the specific carbohydrate diet for 8 weeks, with support from dietitians. The main goal was to see if the diets changed the diversity of bacteria in the gut, and researchers also tracked liver enzyme levels.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
dietary intervention (vegan/low-sulfur diet or specific carbohydrate diet)
What this could lead to
If successful, this study could point toward a dietary approach that improves gut health and liver function in people with primary sclerosing cholangitis.
What could go wrong
This is a very small pilot study with only 20 participants, so results may not apply to everyone. It also relies on participants sticking to strict diets, which can be hard to maintain.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

20 people

The number who actually took part.

Started

Aug 2020

Finished

Dec 2021

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Males and females between 18 and 70 years of age, inclusive based on the date of the screening visit 2. Willing and able to give informed consent prior to any study specific procedures being performed 3. Diagnosis of PSC documented by typical cholangiogram findings with no evidence of a secondary cause of sclerosing cholangitis 4. Serum alkaline phosphatase greater than 1.5 times the upper limit of the normal (ULN) reference range 5. Simple clinical colitis activity index \< 5 6. 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. 7. Platelet count \> 150,000/mm3 8. Albumin \> 3.3 g/dL 9. Serum creatinine \< ULN 10. 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 11. Able to read English and complete PSC PRO independently Exclusion Criteria: 1. Pregnant or lactating females 2. ALT \> 10 x ULN 3. Total bilirubin \> 2 X ULN 4. INR \> 1.2 5. Decompensated cirrhosis defined by ascites, hepatic encephalopathy, or variceal bleeding 6. Small duct PSC 7. 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 8. Positive AMA 9. History of liver transplantation 10. History of hepatocellular carcinoma or cholangiocarcinoma 11. Ascending cholangitis within 90 days of enrollment 12. Any antibiotic use within 90 days of enrollment or planned antibiotic use during the study period 13. Current vegetarian or adherence to the SCD 14. 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). 15. Inability to complete dietary log. 16. History of malignancy within 5 years except for adequately treated carcinoma in situ of the cervix and basal or squamous cell carcinoma. 17. Concurrent participation in another therapeutic clinical trial 18. Celiac disease 19. 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

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Conditions

The condition(s) this trial relates to.

Cholangitis, Sclerosing primary sclerosing cholangitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.