What is the mechanism of action of this treatment?

Common treatments for Ulcerative Colitis (UC) include anti-inflammatory agents such as 5-aminosalicylic acid (5-ASA) and corticosteroids, which reduce inflammation in the colon by inhibiting the production of inflammatory cytokines. Immunosuppressants like azathioprine and biologics such as TNF inhibitors work by dampening the immune response that drives inflammation. Dietary interventions, including the use of natural compounds like sulforaphane found in broccoli sprouts, aim to reduce inflammation by enhancing the body's antioxidant defenses and modulating inflammatory pathways. These treatments are crucial for UC patients as they help manage symptoms, maintain remission, and improve quality of life by targeting the underlying inflammatory processes.

What side effects are associated with this type of intervention?

Common treatments for Ulcerative Colitis include aminosalicylates, corticosteroids, and probiotics. Aminosalicylates, like mesalamine, can cause side effects such as nausea, headache, fever, rash, pancreatitis, and pneumonitis. Corticosteroids, used for their anti-inflammatory properties, may lead to systemic side effects like adrenal suppression, osteoporosis, weight gain, and increased infection risk. Probiotics are generally well-tolerated but can occasionally cause bloating and gas. Sulforaphane, found in broccoli sprouts, is being studied for its anti-inflammatory effects, and while generally considered safe, it may cause gastrointestinal discomfort in some individuals.

What prior FDA approvals exist?

FDA-approved treatments for Ulcerative Colitis include mesalamine, a 5-aminosalicylate used for maintaining remission, vedolizumab, a gut-selective integrin antibody for moderate to severe UC, and golimumab, an anti-TNF agent for induction and maintenance. These treatments focus on immune modulation and inflammation control, differing from the broccoli sprouts trial, which aims to reduce inflammation by increasing sulforaphane levels.

What other types of research exist?

Promising alternatives to broccoli sprouts for reducing inflammation in ulcerative colitis patients include curcumin supplementation, which has been reported to reduce symptoms and inflammatory indices, and vitamin D supplementation, which may help reduce disease activity. Additionally, therapies that modify intestinal microbiota, such as probiotics and fecal microbiota transplantation, are being explored for their potential benefits in UC.

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Cruciferous Vegetables

Broccoli Sprouts for Ulcerative Colitis

N/A

Recruiting

Led By Grace Chen

Research Sponsored by University of Michigan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 28

Awards & highlights

Summary

This trial is testing if eating broccoli sprouts can help patients with mild ulcerative colitis by increasing a compound called sulforaphane in their bodies, which may reduce inflammation. Sulforaphane (SFN), an isothiocyanate present in cruciferous vegetables such as broccoli and brussels sprouts, has a variety of biological functions.

Who is the study for?

This trial is for adults with mild ulcerative colitis, who are on a stable dose of certain medications like Aminosalicylic acids or Imuran. Participants should have a BMI between 18.5-40 and not be consuming more than 5 ½ cups of fruits and vegetables daily. They must understand the study and consent to it.

What is being tested?

The study tests if eating either one or three servings of broccoli sprouts can increase sulforaphane levels in the body and decrease inflammation markers in patients with mild ulcerative colitis, as preparation for a larger future trial.

What are the potential side effects?

While specific side effects aren't listed, participants may experience changes related to their digestive system due to increased intake of broccoli sprouts.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 28

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 28

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 28 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Feasibility of adopting a steamed broccoli diet in patients with inflammatory bowel disease ulcerative colitis as measured by participant compliance.

Ulcerative Colitis

Levels of sulforaphane in the blood

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: 3 Servings of broccoli sproutsExperimental Treatment1 Intervention

339 grams

Group II: 1 Serving of broccoli sproutsExperimental Treatment1 Intervention

113 grams

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Ulcerative Colitis (UC) include anti-inflammatory agents such as 5-aminosalicylic acid (5-ASA) and corticosteroids, which reduce inflammation in the colon by inhibiting the production of inflammatory cytokines. Immunosuppressants like azathioprine and biologics such as TNF inhibitors work by dampening the immune response that drives inflammation. Dietary interventions, including the use of natural compounds like sulforaphane found in broccoli sprouts, aim to reduce inflammation by enhancing the body's antioxidant defenses and modulating inflammatory pathways. These treatments are crucial for UC patients as they help manage symptoms, maintain remission, and improve quality of life by targeting the underlying inflammatory processes.

Probiotics for induction of remission in ulcerative colitis.

Find a Location

Who is running the clinical trial?

University of MaineOTHER

3 Previous Clinical Trials

6,665 Total Patients Enrolled

University of MichiganLead Sponsor

1,833 Previous Clinical Trials

6,423,088 Total Patients Enrolled

1 Trials studying Ulcerative Colitis

68 Patients Enrolled for Ulcerative Colitis

Grace ChenPrincipal InvestigatorUniversity of Michigan

Media Library

Broccoli Sprouts (Cruciferous Vegetables) Clinical Trial Eligibility Overview. Trial Name: NCT05507931 — N/A

Ulcerative Colitis Research Study Groups: 1 Serving of broccoli sprouts, 3 Servings of broccoli sprouts

Ulcerative Colitis Clinical Trial 2023: Broccoli Sprouts Highlights & Side Effects. Trial Name: NCT05507931 — N/A

Broccoli Sprouts (Cruciferous Vegetables) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05507931 — N/A

~19 spots leftby Dec 2025

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