COMPLETED

Broccoli Sprouts for Mild Ulcerative Colitis

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Conditions

Ulcerative ColitisUlcerative Colitis Chronic Mildsulforaphaneinflammatory markersInflammatory bowel diseasediet

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this study is to determine the number of servings of broccoli sprouts sufficient to (1) increase sulforaphane levels in the stool and blood and (2) reduce inflammatory markers in patients with mild ulcerative colitis. This is a pilot feasibility study to prepare for a larger randomized controlled trial.

Official Title

A Pilot Feasibility Study to Develop a Broccoli Sprouts-enriched Diet in the Management of Ulcerative Colitis

Quick Facts

Study Start:2023-05-23
Study Completion:2026-01-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT05507931

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Documented endoscopic diagnosis of ulcerative colitis
  2. * Currently being treated with a stable dose of 5-ASAs, steroids, or any other medication approved for ulcerative colitis
  3. * If on 5-ASA, no dose changes within 2 weeks before the Day 0 visit
  4. * If on steroids, prednisone dose not more than 20 mg daily and entocort not more than 9 mg daily, with no dose changes within 2 weeks before the Day 0 visit
  5. * All other medications require a stable dose for at least 8 weeks prior to enrollment.
  6. * No dose changes to any IBD medication anticipated for the duration of the study
  7. * Body Mass Index (BMI) values 18.5-40 kg/m2
  8. * Not on total parenteral nutrition (TPN) or receiving tube feeds.
  9. * Ability to understand the study procedures, benefits and risks, and sign a written informed consent document.
  10. * Able to fill out questionnaires regarding dietary intakes, bowel symptoms, and study experience
  1. * Taking Non-steroidal anti-inflammatory drugs (NSAIDs)
  2. * Following a medically-prescribed diet, on Total parenteral nutrition (TPN), or tube feeds
  3. * Newly diagnosed (within past month), or uncontrolled diabetes or cardiovascular disease
  4. * Antibiotics in the previous 2 weeks
  5. * Consumption of more than 5 ½ cups of servings/day of fruits and vegetables as assessed by the National Cancer Institute (NCI) Diet History Questionaire III online Food Questionnaire.
  6. * A known allergy or sensitivity to cruciferous vegetables like arugula, bok choy, broccoli, cabbage, cauliflower, or collard greens

Contacts and Locations

Principal Investigator

Grace Chen
PRINCIPAL_INVESTIGATOR
University of Michigan

Study Locations (Sites)

University of Michigan
Ann Arbor, Michigan, 48109
United States

Collaborators and Investigators

Sponsor: University of Michigan

  • Grace Chen, PRINCIPAL_INVESTIGATOR, University of Michigan

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-23
Study Completion Date2026-01-09

Study Record Updates

Study Start Date2023-05-23
Study Completion Date2026-01-09

Terms related to this study

Keywords Provided by Researchers

  • sulforaphane
  • inflammatory markers
  • Inflammatory bowel disease
  • diet
  • ulcerative colitis

Additional Relevant MeSH Terms

  • Ulcerative Colitis
  • Ulcerative Colitis Chronic Mild