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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
Awards & highlights
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
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 moreSecondary 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
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.
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Who is running the clinical trial?
James VaraniLead Sponsor
2 Previous Clinical Trials
66 Total Patients Enrolled
1 Trials studying Ulcerative Colitis
30 Patients Enrolled for Ulcerative Colitis
Muhammad N AslamStudy DirectorUniversity of Michigan
2 Previous Clinical Trials
40 Total Patients Enrolled
1 Trials studying Ulcerative Colitis
30 Patients Enrolled for Ulcerative Colitis
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Eligibility Criteria:
This trial includes the following eligibility 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).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.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo first then Aquamin®
- Group 2: Aquamin®
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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