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NCT04678219 · ClinicalTrials.gov registry record · NA
A Pilot Study Examining Diet in Primary Sclerosing Cholangitis
A NA study of Primary Sclerosing Cholangitis, sponsored by Brigham and Women's Hospital.
- Completed
- Registry status
- NA
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT04678219: Completed NA study of Primary Sclerosing Cholangitis, sponsored by Brigham and Women's Hospital.
NCT04678219 is a NA study of Primary Sclerosing Cholangitis that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 20 participants, below the 552-participant average among 23 other Primary Sclerosing Cholangitis trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04678219, a NA study of Primary Sclerosing Cholangitis, has completed, sponsored by Brigham and Women's Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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).
Conditions Studied
Interventions
- OTHER Dietary Intervention
Study Locations (1)
Massachusetts
- Brigham and Women's Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2020-08-28 |
| Est. Completion | 2021-12-01 |
| Phase | NA |
What the finished NCT04678219 record still lists
NCT04678219 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 552-participant average among 23 other Primary Sclerosing Cholangitis trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Primary Sclerosing Cholangitis appearing as the primary indexed condition, and to 1 intervention - of which Dietary Intervention is the first listed.
NCT04678219 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT04678219 about?
NCT04678219 is a clinical study titled "A Pilot Study Examining Diet in 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 Register...
What is the current status of trial NCT04678219?
This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2020-08-28. Estimated completion is 2021-12-01.
What conditions does trial NCT04678219 study?
This clinical trial studies the following conditions: Primary Sclerosing Cholangitis.
What interventions are being tested in trial NCT04678219?
The interventions under investigation include: Dietary Intervention (OTHER).
Who is sponsoring clinical trial NCT04678219?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04678219 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04678219's enrollment target sits among peer trials
20 21st of 23 higher than 3 of 23 other Primary Sclerosing Cholangitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Primary Sclerosing Cholangitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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