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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 up to 5 years
Awards & highlights
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.
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Trial Design
1Treatment groups
Experimental Treatment
Group I: Aquamin®Experimental Treatment1 Intervention
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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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You must have symptoms that match the criteria for Irritable Bowel Syndrome with Diarrhea (IBS-D) as described in the study protocol.I am between 18 and 80 years old and generally healthy.I have ulcerative colitis in remission or mild, without steroids or antibiotics for 3 months.I am not pregnant and agree to use birth control during the study.If I stopped having periods within the last year, I will be considered pre-menopausal and need a pregnancy test.I am between 18 and 80 years old.You must be able to read and sign a document that explains the study and your participation in it.I am a pre-menopausal woman with a negative pregnancy test taken within the last 2 weeks.I am between 18 and 80 years old.If you are a woman of childbearing age, you must agree to use birth control during the study. If you have stopped having periods for more than a year, you are post-menopausal. If it has been less than a year, you will be considered pre-menopausal and will need to take a pregnancy test.
Research Study Groups:
This trial has the following groups:- Group 1: Aquamin®
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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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