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Aquamin® for Ulcerative Colitis

Phase 2

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to day 180

Awards & highlights

Study Summary

This trial will test if Aquamin, a supplement derived from red algae, can improve symptoms and induce remission in patients with mild Ulcerative Colitis, and extend remission in patients who are already in remission.

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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

Do I qualify?Apply below to find out

Find a Location

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

Media Library

Aquamin® Clinical Trial Eligibility Overview. Trial Name: NCT03869905 — Phase 2

Ulcerative Colitis Research Study Groups: Placebo first then Aquamin®, Aquamin®

Ulcerative Colitis Clinical Trial 2023: Aquamin® Highlights & Side Effects. Trial Name: NCT03869905 — Phase 2

Aquamin® 2023 Treatment Timeline for Medical Study. Trial Name: NCT03869905 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there precedent studies to support the benefits of Aquamin®?

"There are 4 active clinical trials at the moment that concern Aquamin®. 0 of those studies are in their third and final phase. Even though most research is based out of Xi'an, Shanxi, there are other facilities running similar tests in 4 other locations."

Answered by AI

Can patients still join this trial?

"The clinical trial detailed on clinicaltrials.gov is still recruiting patients; it was originally posted on 8/8/2019 and updated as recently as 4/7/2022."

Answered by AI

Who meets the eligibility requirements for participating in this clinical trial?

"Up to 40 individuals that have been diagnosed with colitis and are between 18-80 years old can participate in this trial. The key eligibility requirements are as follows: a confirmed diagnosis of ulcerative colitis via histology and endoscopy, being in remission for at least 3 months without treatment or only receiving maintenance therapies (corticosteroids, antibiotics exempted), or having mild disease symptoms. Lastly, all participants must provide a negative pregnancy test."

Answered by AI

How many patients are being given this treatment?

"Yes, this is an active study that has updated their information on clinicaltrials.gov as recently as April 7th, 2022. They are looking for 40 individuals to participate at a single location."

Answered by AI