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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether Aquamin® (a natural mineral supplement) can improve symptoms and induce remission in individuals with mild ulcerative colitis, a condition causing inflammation in the colon. The study will compare Aquamin® to a placebo to assess its effectiveness over time. Participants must have a confirmed diagnosis of ulcerative colitis, be in stable remission without steroids or antibiotics, or have mild disease. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

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.

Is there any evidence suggesting that Aquamin® is likely to be safe for humans?

Research has shown that Aquamin®, a supplement from the sea, is generally safe and well-tolerated. In a study with healthy individuals, Aquamin® caused no major side effects, suggesting it might also be safe for those with ulcerative colitis. Additionally, the FDA has approved Aquamin® as an Investigational New Drug, indicating it has passed certain safety checks for testing. While more research is needed to confirm its safety specifically for ulcerative colitis, the initial results are encouraging. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Ulcerative Colitis?

Aquamin® is unique because it's derived from a natural source—calcified red marine algae—which is different from the typical medications for ulcerative colitis like corticosteroids, immunosuppressants, or biologics. Unlike these standard treatments, Aquamin® is packed with a variety of minerals like calcium and magnesium that could potentially help reduce inflammation without the side effects often associated with conventional drugs. Researchers are excited because it offers a more natural approach to managing ulcerative colitis, potentially providing relief with fewer risks and complications.

What evidence suggests that Aquamin® might be an effective treatment for Ulcerative Colitis?

Research has shown that Aquamin®, a natural product with multiple minerals, may help reduce inflammation in the colon for people with ulcerative colitis. In this trial, some participants will take Aquamin® for 180 days, while others will start with a placebo for the first 90 days and then switch to Aquamin® for the last 90 days. Studies have found that people using Aquamin® for 180 days experienced improvements in all markers indicating disease activity. It outperforms calcium alone in slowing harmful cell growth and promoting healthy cell development in the colon. Additionally, Aquamin® has strengthened the gut lining, potentially protecting it from further damage. These findings suggest that Aquamin® could be a promising treatment to improve symptoms and extend symptom-free periods in ulcerative colitis. ^{1 2 3 5 6}

Who Is on the Research Team?

James Varani

Principal Investigator

University of Michigan

Muhammad N Aslam

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10354648/

A multi-mineral intervention to counter pro-inflammatory ... These findings suggest that multi-mineral intervention (Aquamin ® ) may provide a novel approach to combating inflammation in the colon by improving barrier ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03869905

Aquamin® as an Adjuvant Intervention for Ulcerative Colitis The purpose of this study is to determine if Aquamin® works as a potential treatment to improve symptoms and if it will induce remission in patients with ...

3. medrxiv.org medrxiv.org/content/10.1101/2025.02.17.25322298v1.full-text

A MULTI-MINERAL INTERVENTION TO IMPROVE ... Results Subjects receiving Aquamin for the complete 180-day period (a total of 12) demonstrated improvement in all biomarkers; this was not seen ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7719760/

Ulcerative Colitis-Derived Colonoid Culture: A Multi-Mineral ... Recent studies demonstrated that Aquamin®, a calcium-, magnesium-rich, multi-mineral natural product, improves barrier structure and function in colonoids ...

5. aquamin.com aquamin.com/wp-content/uploads/2023/08/29.-Aslam-et-al.-2019-90-day-study.pdf

A Calcium-Rich Multimineral Intervention to Modulate ... Further, Aquamin was more effective than calcium alone at suppressing proliferation and inducing differentiation in human colon carcinoma cells in monolayer ...

6. withpower.com withpower.com/trial/phase-3-ulcer-7-2019-9a737

Aquamin® for Ulcerative Colitis · Info for Participants 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.