Aquamin® for Ulcerative Colitis

Overseen By Muhammad Nadeem Aslam

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: James Varani

Must not be taking: Calcium, Vitamin D, NSAIDs, others

Disqualifiers: Crohn's, Kidney disease, Coagulopathy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 26 weeks

40 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications like Calcium, Vitamin D, fiber supplements, and NSAIDs (non-steroidal anti-inflammatory drugs) at least 30 days before starting. If you're on maintenance therapy for Ulcerative Colitis, you can continue that, but not steroids or antibiotics for the last 3 months.

Research Team

James Varani

Principal Investigator

University of Michigan

Muhammad N Aslam

Principal Investigator

University of Michigan

Eligibility Criteria

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.

Inclusion Criteria

My ulcerative colitis is in remission or mild, and I've been stable for 3+ months with or without maintenance therapy (no steroids/antibiotics).

A negative pregnancy test

Exclusion Criteria

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.

I have taken calcium, vitamin D, fiber supplements, or NSAIDs in the last 30 days.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Placebo or Aquamin® for 180 days, with a crossover from Placebo to Aquamin® after 90 days

26 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Aquamin®

Trial Overview 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.

Participant Groups

Group I: Aquamin® Experimental Treatment 1 Intervention

To be taken for 180 days

Group II: Placebo first then Aquamin® Placebo Group 2 Interventions

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

Who Is Running the Clinical Trial?

James Varani

Lead Sponsor

Trials

3

Recruited

110+