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Mineral Supplement

Aquamin for GI Health

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
Age 18 to 80 years old.
Pre-menopausal women with intact female reproductive organs must have a negative pregnancy test within 2 weeks of the Baseline Visit.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (pre-intervention), 90 days (post-intervention)
Awards & highlights

Study Summary

This trial is studying how Aquamin affects the GI tract in people with UC, IBS-D, and in healthy individuals.

Who is the study for?
This trial is for healthy adults, and those with Irritable Bowel Syndrome-Diarrhea (IBS-D) or stable/mild Ulcerative Colitis (UC), aged 18-80. Participants must be able to consent, women of childbearing potential need a negative pregnancy test and agree to use birth control. Those recently off menses are considered pre-menopausal.Check my eligibility
What is being tested?
The study investigates the effects of Aquamin on gut permeability in individuals with UC, IBS-D, and healthy volunteers. It aims to understand how this supplement influences the movement of substances through the gut wall into the body.See study design

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 80 years old.
Select...
I am a pre-menopausal woman with a negative pregnancy test taken within the last 2 weeks.
Select...
I am between 18 and 80 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (pre-intervention), 90 days (post-intervention)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (pre-intervention), 90 days (post-intervention) 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 the lactulose:mannitol ratio in urine by comparing values at 90-days (post-intervention) to baseline (pre-intervention) levels.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Aquamin®Experimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

James VaraniLead Sponsor
2 Previous Clinical Trials
76 Total Patients Enrolled
1 Trials studying Ulcerative Colitis
40 Patients Enrolled for Ulcerative Colitis
Muhammad N AslamStudy DirectorUniversity of Michigan
2 Previous Clinical Trials
50 Total Patients Enrolled
1 Trials studying Ulcerative Colitis
40 Patients Enrolled for Ulcerative Colitis

Media Library

Aquamin (Mineral Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT04855799 — Phase 2
Ulcerative Colitis Research Study Groups: Aquamin®
Ulcerative Colitis Clinical Trial 2023: Aquamin Highlights & Side Effects. Trial Name: NCT04855799 — Phase 2
Aquamin (Mineral Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04855799 — Phase 2

Frequently Asked Questions

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

Has the FDA granted clearance to Aquamin as a drug?

"Although there is evidence backing Aquamin's safety, the lack of efficacy data warrants a score of 2 on a safety scale."

Answered by AI

Is this randomized trial currently admitting participants?

"Data hosted on the clinicaltrials.gov website suggests that this medical trial is presently recruiting participants, having been initially posted in November 2021 and revised most recently in November 2022."

Answered by AI

Does the age criterion for this experiment include those above sixty years of age?

"To be qualified for this medical trial, a patient must fall between the age brackets of 18 and 80. However, there are 142 studies designed specifically for minors while 662 others have been developed catered to people aged 65 or more."

Answered by AI

What is the current enrollment size of this research project?

"Affirmative. According to the details available on clinicaltrials.gov, this trial is presently recruiting participants and was first announced in November 2021 with a most recent update of November 2022. Currently, 30 people are needed for the study at 1 medical site."

Answered by AI

Is it possible for me to partake in this experimental procedure?

"This research trial is currently looking for 30 participants suffering from diarrhoea, aged between 18 and 80. To be eligible applicants must meet the following criteria: Posses written informed consent; Age range from 18-80 years old with confirmed diagnosis of ulcerative colitis by histology and endoscopy in stable remission for 3 months or more without therapy (except steroids and antibiotics over a period of three months) or have mild symptoms, Negative pregnancy test for pre-menopausal women with intact reproductive organs who agree to use birth control measures during study duration, General healthiness among male/female subjects within set age limits, Pre-men"

Answered by AI

Who else is applying?

What state do they live in?
Michigan
What site did they apply to?
University of Michigan Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria
~3 spots leftby Aug 2024