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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 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.

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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.

Interventions

  • OTHER Dietary Intervention

Study Locations (1)

Massachusetts

  • Brigham and Women's Hospital - Boston

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2020-08-28
Est. Completion 2021-12-01
Phase NA

Sponsor

Brigham and Women's Hospital

937 total trials

What the Registry Record Tells You About NCT04678219

The ClinicalTrials.gov registry entry for NCT04678219 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 552-participant average among 23 other Primary Sclerosing Cholangitis trials with a reported enrollment target (96% lower). The listed sponsor is Brigham and Women's Hospital, which has 937 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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