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Broccoli Sprouts for Mild Ulcerative Colitis
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.
Conditions:
🦠 Ulcerative Colitis 🦠 Ulcerative Colitis Chronic Mild
🗓️ Study Start (Actual) 23 May 2023
🗓️ Primary Completion (Estimated) 31 December 2025
✅ Study Completion (Estimated) 31 December 2025
👥 Enrollment (Estimated) 40
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Ann Arbor, Michigan, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Documented endoscopic diagnosis of ulcerative colitis
    • * Currently being treated with a stable dose of 5-ASAs, steroids, or any other medication approved for ulcerative colitis
    • * If on 5-ASA, no dose changes within 2 weeks before the Day 0 visit
    • * 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
    • * All other medications require a stable dose for at least 8 weeks prior to enrollment.
    • * No dose changes to any IBD medication anticipated for the duration of the study
    • * Body Mass Index (BMI) values 18.5-40 kg/m2
    • * Not on total parenteral nutrition (TPN) or receiving tube feeds.
    • * Ability to understand the study procedures, benefits and risks, and sign a written informed consent document.
    • * Able to fill out questionnaires regarding dietary intakes, bowel symptoms, and study experience

    Exclusion Criteria:

    • * Taking Non-steroidal anti-inflammatory drugs (NSAIDs)
    • * Following a medically-prescribed diet, on Total parenteral nutrition (TPN), or tube feeds
    • * Newly diagnosed (within past month), or uncontrolled diabetes or cardiovascular disease
    • * Antibiotics in the previous 2 weeks
    • * 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.
    • * A known allergy or sensitivity to cruciferous vegetables like arugula, bok choy, broccoli, cabbage, cauliflower, or collard greens
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ 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

  • First Submitted 17 August 2022
  • First Submitted that Met QC Criteria 17 August 2022
  • First Posted 19 August 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 15 July 2024
  • Last Update Posted 16 July 2024
  • Last Verified July 2024
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