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GI Permeability Change in Response to Aquamin® | Clinical Trials | Clareo Health

COMPLETEDPHASE2

GI Permeability Change in Response to Aquamin®

Direct Measurement of Gastrointestinal Permeability Change in Response to Aquamin®

NCT04855799•James Varani

Summary

This trial is being completed to learn about how Aquamin® affects gastrointestinal permeability, or the control of material passing from inside the gastrointestinal tract through the gut wall into the rest of the body, in people with ulcerative colitis (UC), Irritable Bowel Syndrome with diarrhea (IBS-D), and in healthy individuals.

Detailed Description

This is a sub-study to the ongoing clinical trial entitled: Aquamin®, a multi-mineral natural product from red marine algae, as an adjuvant intervention for mild ulcerative colitis and ulcerative colitis in remission (HUM00156676) NCT# NCT03869905.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Must be able to give written informed consent
•Age 18 to 80 years old.
•Must have: Ulcerative colitis with confirmed diagnosis by histology and endoscopy; and be in stable remission for 3 months or more without therapy or with maintenance therapy (except steroids and antibiotics for 3 months) or have mild ulcerative colitis. Note: Corticosteroids (a type of steroid drug such as prednisone or cortisol that helps the body to regulate stress response, immune response and inflammation) and antibiotics can be used during a flare-up once the study has begun and the subject enrolled.
•A negative pregnancy test for pre-menopausal women with intact female reproductive organs. Must agree to use appropriate birth control over the study period (if applicable).
•If cessation of menses is within 12 months, then the participant will be treated as pre-menopausal and a pregnancy test will be performed.
•Must be able to give written informed consent
•Be generally healthy, male or female, ages 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.
•Subject must agree to use appropriate birth control over the study period. (Post-menopausal is defined as no menses for the previous 12 months. If cessation of menses is within 12 months, then the participant will be treated as pre-menopausal and a pregnancy test will be performed.
•Patients with ages 18-80 years old.
+2 more criteria

Exclusion Criteria

•Must not be pregnant or lactating
•Must not be participating in any other interventional trial using an investigational drug.
•Subjects likely to be uncooperative or unable to comply with study procedures
•Participants must not be felt to have active ulcerative colitis for 3 months before study enrollment (with an exception of mild ulcerative colitis).
•Participants must not have a history or diagnosis of any of the following conditions:
•Crohn's disease, Any stomach or intestinal bleeding disorders (gastrointestinal bleeding from gastric or duodenal ulcers, or gastrin secreting tumors) or active gastric/duodenal ulcers - peptic ulcer disease (without bleeding in last 3 months).
•Must not have any gastrointestinal or colonic malignancy.
•Must not have Kidney disease, including kidney "stones" or hypercalcemia.
•Must not have Coagulopathy/hereditary hemorrhagic disorders
•Participants will be excluded if they have taken certain medications (per protocol), within the last 30 days or are unwilling to forgo the following for 30 days prior to entry into the study.
+13 more criteria

Locations (1)

University of Michigan Hospital

Ann Arbor, Michigan, United States

Key Dates

Start Date

November 2, 2021

Primary Completion Date

March 11, 2024

Completion Date

March 25, 2024

Last Updated

February 24, 2025

Enrollment

ACTUAL participants

Conditions

Ulcerative ColitisHealthyIrritable Bowel Syndrome With Diarrhea

Interventions

Aquamin

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 24, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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GI Permeability Change in Response to Aquamin®

Inclusion Criteria

Exclusion Criteria

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