180 Participants NeededMy employer runs this trial

Selenium Supplementation for Ulcerative Colitis

(Selenium-UC Trial)

LR
DJ
Overseen ByDiego Jimenez Lara
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Northwestern University
Must be taking: Biologics, Small molecules
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether selenium supplements can help people with moderate to severe ulcerative colitis (UC) respond better to advanced treatments like biologics. Selenium, a mineral, might reduce inflammation in the colon and potentially ease UC symptoms. Participants will take either a selenium supplement or a placebo (a pill with no active ingredient) daily for 12 weeks. Those diagnosed with moderate to severe UC who are starting or switching to new advanced therapies might be a good fit for this trial. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to potentially benefit from new therapeutic strategies.

Do I need to stop my current medications for the trial?

Yes, you may need to stop certain medications. The trial excludes participants taking blood thinners, cholesterol-lowering drugs, antioxidants, warfarin, or other medications that might interact with selenium. Check the specific list of medications to see if yours is included.

Is there any evidence suggesting that selenium supplementation is likely to be safe for humans?

Research has shown that selenium supplements might be safe for people with ulcerative colitis. For example, one study found that selenium reduced symptoms in adults with mild to moderate ulcerative colitis. Another study demonstrated that selenium improved the body's ability to combat damage and eased symptoms by reducing gut inflammation. These findings suggest that selenium might help manage ulcerative colitis without causing major side effects. However, as with any treatment, monitoring for negative effects and discussing them with a doctor is important.12345

Why do researchers think this study treatment might be promising for ulcerative colitis?

Unlike standard treatments for ulcerative colitis, which often include anti-inflammatory drugs, immunosuppressants, or biologics, selenium supplementation offers a unique approach by utilizing the antioxidant properties of selenium. Researchers are excited about selenium because it targets oxidative stress, a factor believed to contribute to inflammation in ulcerative colitis. By potentially reducing oxidative damage in the colon, selenium might offer a gentler alternative with fewer side effects compared to traditional medications. This novel method of addressing inflammation could lead to a new avenue for managing ulcerative colitis symptoms.

What evidence suggests that selenium supplementation might be an effective treatment for ulcerative colitis?

Studies have shown that selenium supplements can help reduce inflammation and symptoms in people with ulcerative colitis (UC). One clinical trial found that selenium eased UC symptoms, improving patients' health. Another study demonstrated that selenium-enriched supplements increased the body's antioxidant levels, which also relieved symptoms. Research indicates that people with UC often have lower selenium levels, potentially worsening their condition. In this trial, participants in the active intervention group will receive selenium supplementation, while others will receive a placebo. Overall, these findings suggest that selenium supplements could be a promising way to manage UC symptoms.14567

Are You a Good Fit for This Trial?

This trial is for adults aged 18-85 with moderate to severe ulcerative colitis who are starting or switching to advanced therapies. Participants must not be pregnant, breastfeeding, have certain medical conditions or allergies, and should be able to follow the study requirements.

Inclusion Criteria

I am starting or switching to a new FDA-approved advanced therapy for my condition.
Mayo endoscopic sub-score ≥2 (moderate to severe)
Mayo rectal bleeding sub-score ≥1 (moderate to severe)
See 3 more

Exclusion Criteria

I am younger than 18 years old.
Patients currently pregnant, expecting to participate in getting pregnant during the study period, or currently lactating
Patients with childbearing potential must use highly effective birth control if not surgically sterile or postmenopausal for ≥ 2 years
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either 200 mcg selenomethionine or a placebo daily for 12 weeks

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Selenium

Trial Overview

The study tests whether taking selenium supplements helps people with moderate to severe ulcerative colitis respond better to advanced treatments compared to a placebo. Participants are randomly assigned either selenium or a placebo.

How Is the Trial Designed?

2

Treatment groups

Active Control

Placebo Group

Group I: Selenium supplementationActive Control1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials
1,674
Recruited
989,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials
2,513
Recruited
4,366,000+

Citations

Selenium, Immunity, and Inflammatory Bowel Disease - PMC

Selenium deficiency is common in IBD, and published data indicate that Se deficiency can increase the severity of murine colitis, and ...

Study on the treatment of ulcerative colitis with selenium- ...

Results showed that selenium-enriched Bifidobacteria significantly improved antioxidant capacity and alleviated UC symptoms by reducing ...

Selenium Compound Shields Against Ulcerative Colitis

SLL-1-43, a selenium compound, reduced colitis symptoms in mice by targeting NOX2 and easing inflammation, oxidative stress.

Selenium deficiency in inflammatory bowel disease

The meta-analysis demonstrated that inflammatory bowel disease patients have significantly lower selenium levels compared to the control group.

Selenium: A Key Element in Inflammatory Bowel Disease

This comprehensive review examines current evidence on the relationship between Se status and IBD, integrating epidemiological and experimental findings, ...

The rationale for selenium supplementation in ...

Selenium contributes to effective function of antioxidant system and alleviates colitis. Selenium contributes to mucosal healing by modification of immune ...

Can selenium reduce the symptoms of ulcerative colitis?

In this randomized controlled trial, supplementation with selenium in adults with mild–moderate active ulcerative colitis (UC) decreased UC symptoms.