GI Permeability Change in Response to Aquamin®

May 12, 2026 updated by: James Varani

Direct Measurement of Gastrointestinal Permeability Change in Response to Aquamin®

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
35

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria for UC participants:

  • 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.

Inclusion Criteria for Healthy participants:

  • 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.

Inclusion Criteria for participants with IBS-D:

  • Patients with ages 18-80 years old.
  • Must meet the IBS-D Diagnostic Rome IV (four) Criteria as noted in the protocol
  • A negative pregnancy test for pre-menopausal cis-women with intact vagina, uterus, and/or ovaries. The negative pregnancy test must be within 2 weeks of the baseline visit and the subject must agree to use appropriate birth control over the study period.

Exclusion Criteria For UC participants:

  • 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.

Exclusion Criteria For Healthy participants:

  • Must not be pregnant or lactating.
  • Must not be participating in any other interventional trial using an investigational drug.
  • Participants must not have a history or diagnosis of any of the following conditions:

Kidney disease, including kidney "stones" or hypercalcemia, Crohn's disease, Neurologic disease, other inflammatory bowel 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).

  • Not have Coagulopathy/hereditary hemorrhagic disorders
  • Any gastrointestinal or colonic malignancy.
  • 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.

Exclusion Criteria for participants with IBS-D:

  • Must not be pregnant or lactating
  • Must not be participating in any other interventional trial using an investigational drug.
  • Participants must not have a history or diagnosis of Crohn's disease or Inflammatory bowel 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, Coagulopathy/hereditary hemorrhagic disorders, neurologic disease
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Aquamin®
Drug: Aquamin
Participants will take a 90-day supply of Aquamin®, 4 capsules per day; 2 to be taken in the morning and 2 in the evening (containing approximately 800 mg calcium/day).
Other Names:
  • Nutritional

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in the Lactulose:Mannitol Ratio in Urine by Comparing Values at 90-days (Post-intervention) to Baseline (Pre-intervention) Levels.
Time Frame: Baseline (pre-intervention), 90 days (post-intervention)
Baseline (pre-intervention), 90 days (post-intervention)
Mannitol Levels in Urine Samples
Time Frame: 90 days

Though lactulose measurements could not be taken from urine samples, the study team was able to measure mannitol levels in those samples. Higher mannitol levels in urine indicate higher levels of permeability.

Participants provided baseline urine samples before drinking a mixture of lactulose/mannitol powder and water. Additional samples were then provided within 0-2 hour window, within a 2-8 hour window, and within an 8-24 hour window of drinking the lactulose/mannitol solution. This test was performed on "day 0" (prior to the participant beginning Aquamin treatment) and day 90 (after the participant had been taking Aquamin for 90 days).
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
James Varani

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: James Varani, University of Michigan
  • Study Director: Muhammad N Aslam, University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 2, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 11, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 25, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 20, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 22, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HUM00156676 sub-study 1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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