What side effects are associated with this type of intervention?

Common treatments for Ulcerative Colitis with anti-inflammatory properties and gut health support, such as mesalamine (5-ASA), can cause side effects including nausea, headache, fever, rash, pancreatitis, and pneumonitis. Probiotics, while generally safe, have unclear benefits and their side effects are not well-defined. Dietary supplements like Aquamin® are still under study, but potential side effects could include gastrointestinal upset. It is important to consult with a healthcare provider to tailor treatment plans and monitor for adverse effects.

What prior FDA approvals exist?

The FDA has approved several treatments for Ulcerative Colitis that focus on anti-inflammatory properties and gut health. Mesalamine, a 5-aminosalicylic acid (5-ASA) compound, is commonly used for its anti-inflammatory effects. Other approved treatments include corticosteroids like prednisone for reducing inflammation and immunomodulators such as azathioprine and 6-mercaptopurine. Biologic therapies, including TNF inhibitors like infliximab and adalimumab, and integrin receptor antagonists like vedolizumab, have also been approved. These treatments aim to reduce inflammation and maintain remission, similar to the goals of Aquamin® in supporting gut health through essential minerals.

What other types of research exist?

Promising novel alternatives to Aquamin® for Ulcerative Colitis patients include: 1) Low-FODMAP diet, which has been shown to improve gastrointestinal symptoms in IBD patients. 2) Ustekinumab and Vedolizumab, which are biologic agents used for patients who do not respond to initial biologic therapy. 3) Enteral nutritional therapy, particularly exclusive enteral nutrition (EEN) and partial enteral nutrition (PEN) with a Crohn's disease exclusion diet (CDED), which have shown efficacy in inducing and maintaining remission. These alternatives focus on reducing inflammation and supporting gut health.

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Aquamin® for Ulcerative Colitis

Phase 2

Waitlist Available

Research Sponsored by James Varani

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Must not have

No history or diagnosis of any of the following conditions: Crohn's disease, bleeding disorders, gastrointestinal or colonic malignancy, Kidney disease, including kidney "stones" or hypercalcemia, Coagulopathy/hereditary hemorrhagic disorders/ or receiving therapeutic doses of Coumadin or heparin.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to day 180

Summary

This trial is testing Aquamin®, a seaweed-based supplement rich in minerals, to see if it can help people with mild Ulcerative Colitis feel better and stay symptom-free. The study focuses on patients who have mild symptoms or are already in remission. The idea is that the minerals in Aquamin® might reduce gut inflammation.

Who is the study for?

This trial is for individuals with mild Ulcerative Colitis or those in stable remission, confirmed by tests. Participants must not have used steroids, antibiotics, or certain supplements recently and should not be pregnant. Those with Crohn's disease, bleeding disorders, kidney issues including stones, high calcium levels, or on blood thinners like Coumadin are excluded.

What is being tested?

The study is testing Aquamin®, a marine-sourced supplement to see if it can improve symptoms of Ulcerative Colitis and help maintain remission. Participants will either receive Aquamin® or a placebo initially followed by Aquamin® to compare the effects.

What are the potential side effects?

While specific side effects of Aquamin® are not detailed here, potential risks may include digestive discomfort given its use as an adjuvant treatment for gastrointestinal conditions.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not have Crohn's, bleeding disorders, certain cancers, kidney disease, high calcium levels, or blood clotting disorders, and I'm not on high doses of blood thinners.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to day 180

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to day 180

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 180 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in Cytokine levels of the colon tissue as measured by Interleukin 8 (IL-8) levels assessed by enzyme-linked immunosorbent assay (ELISA)

Change in clinical assessment /gastroenterologist's endoscopic findings based on Ulcerative Colitis Disease Activity Index (UCDAI)/Mayo Scoring

Change in fecal calprotectin levels measured in a stool sample

+2 more

Secondary study objectives

Changes in serum liver function tests

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Aquamin®Experimental Treatment1 Intervention

To be taken for 180 days

Group II: Placebo first then Aquamin®Placebo Group2 Interventions

Placebo: To be taken for the first 90 days. Aquamin®: To be taken for the last 90 days (after crossover)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Aquamin®

2016

Completed Phase 1

~40

0 / 1Eligibility criteria met

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) primarily aim to reduce inflammation and support gut health. Mesalamine, a 5-aminosalicylic acid (5-ASA) compound, works by inhibiting the production of inflammatory mediators in the colon, thereby reducing inflammation and promoting mucosal healing. Glucocorticoids, such as prednisone, act by suppressing the overall immune response, which decreases inflammation but are not suitable for long-term use due to side effects. Aquamin®, a dietary supplement rich in essential minerals like calcium and magnesium, is being studied for its potential to improve gut health and reduce inflammation through its anti-inflammatory properties. These treatments are crucial for UC patients as they help manage symptoms, induce remission, and maintain long-term gut health.