Ulcerative ColitisPhase 2NCT04855799

GI Permeability Change in Response to Aquamin®

A Phase 2 study testing Aquamin in people with Ulcerative Colitis and Healthy, run by James Varani at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for: Ulcerative Colitis, Healthy, Irritable Bowel Syndrome With Diarrhea
What is being tested?: Aquamin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 35 participants
Where: 1 siteUnited States
Study dates: 2 Nov 2021to 25 Mar 2024
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

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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.
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.

Who cannot join

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).

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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.
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.
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.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Michigan Hospital
Ann Arbor, Michigan, 48109

Other trials in United States

About this study

Official title: Direct Measurement of Gastrointestinal Permeability Change in Response to Aquamin®

Read the 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.

Conditions: Ulcerative Colitis, Healthy, Irritable Bowel Syndrome With Diarrhea
Being tested: Aquamin
Keywords: gastrointestinal permeability
Medical subject headings: Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AquaminDrug
Also called Nutritional
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).

Study groups in NCT04855799
Study group	Role	What they receive
Aquamin®	Experimental	Not described Receives: Drug: Aquamin

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in the Lactulose:Mannitol Ratio in Urine by Comparing Values at 90-days (Post-intervention) to Baseline (Pre-intervention) Levels.
Measured: Baseline (pre-intervention), 90 days (post-intervention)
Mannitol Levels in Urine Samples
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).
Measured: 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Nov 202125 Mar 2024

First posted22 Apr 2021
Study start2 Nov 2021
Primary completion11 Mar 2024
Study completion25 Mar 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 35 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04855799
Sponsor's protocol ID: HUM00156676 sub-study 1
Status last verified: May 2026
First submitted: 20 Apr 2021
Last updated: 17 Jul 2026
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Aslam MN, Turgeon DK, Appelman HD, Stidham R, McClintock S, Allen R, Moraga G, Harber I, Jencks KJ, McNeely MM, Sen A, Jepsen KJ, Varani J. A multi-mineral intervention to improve disease-related and mechanistic biomarkers in ulcerative colitis patients: Results from a randomized trial. PLoS One. 2025 Dec 8;20(12):e0337408. doi: 10.1371/journal.pone.0337408. eCollection 2025.
PubMed 41359652
Aslam MN, Turgeon DK, McClintock S, Allen R, Sen A, Varani J. A Multi-Mineral Intervention Improves Intestinal Permeability in Patients with Ulcerative Colitis: Results from a 90-Day Pilot Trial. medRxiv [Preprint]. 2026 Jan 30:2026.01.28.26345064. doi: 10.64898/2026.01.28.26345064.
PubMed 41646788
Aslam MN, Turgeon DK, McClintock S, Allen R, Sen A, Varani J. A multi-mineral intervention is associated with improved intestinal permeability in patients with ulcerative colitis: results from a pilot trial. Front Med (Lausanne). 2026 Jun 22;13:1805900. doi: 10.3389/fmed.2026.1805900. eCollection 2026.
PubMed 42440705

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Direct Measurement of Gastrointestinal Permeability Change in Response to Aquamin®
ClinicalTrials.gov ID: NCT04855799
Acronym / sponsor ID: HUM00156676 sub-study 1
Conditions: Ulcerative Colitis, Healthy, Irritable Bowel Syndrome With Diarrhea
Keywords: gastrointestinal permeability
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 35 participants (actual)
Lead sponsor: James VaraniUniversity, hospital or other
Study start: 2 Nov 2021 (actual)
Primary completion: 11 Mar 2024 (actual)
Study completion: 25 Mar 2024 (actual)
First posted: 22 Apr 2021 (actual)
Results: Posted 8 Jun 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Aquamin®	Experimental	Drug: Aquamin

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

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.

Key exclusion criteria (23 listed)

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:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AquaminAlso: NutritionalParticipants 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).	Drug	Aquamin®

Primary outcome

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)
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).

Results and safety

Results posted to the registry on 8 Jun 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Aquamin® - Healthy Subjects	19	12
Aquamin® - Subjects With Ulcerative Colitis	12	9
Aquamin® - Subjects With IBS-D	4	1

Primary outcome: 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)

Population analysed: Lactulose:mannitol ratio could not be calculated because lactulose measures could not be generated from the urine samples. The study took place over the COVID-19 pandemic, during which the company that manufactured the ELISA assays for lactulose measurement closed and ceased production. Alternatives to these assays were sought and tested, but none were found to be accurate. Therefore, reliable lactulose measurements could not be taken from urine samples. No data will be analyzed in the future.

Primary outcome: Mannitol Levels in Urine Samples

Time frame: 90 days. Mean (Standard Deviation). Unit: mgs

Measure	Aquamin® - Healthy Subjects n = 8	Aquamin® - Subjects With Ulcerative Colitis n = 8
Baseline - Day 0	68.54 (85.03)	110.35 (92.70)
Baseline - Day 90	106.95 (86.68)	51.60 (23.30)
0-2 hour window - Day 0	829.14 (497.29)	1277.08 (503.40)
0-2 hour window - Day 90	978.41 (455.51)	917.63 (352.46)
2-8 hour window - Day 0	663.69 (371.03)	919.87 (346.16)
2-8 hour window - Day 90	700.09 (255.99)	681.10 (390.58)
8-24 hour window - Day 0	229.48 (126.04)	211.04 (105.25)
8-24 hour window - Day 90	251.99 (163.70)	123.52 (84.99)

Aquamin® - Healthy Subjects: p = 0.322, t-test, 2 sided
Aquamin® - Healthy Subjects: p = 0.809, t-test, 2 sided
Aquamin® - Healthy Subjects: p = 0.881, t-test, 2 sided

Population analysed: Data were analyzed from samples that were submitted by participants in the Healthy Subjects and UC arms. Some participants did not submit samples for any time period. One participant did not generate a sample for a single time window. Data from the IBS-D arm was not analyzed due to a lack of usable data.

Adverse events

Time frame: Up to 95 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Aquamin® - Healthy Subjects	0 of 14 (0%)	7 of 14 (50%)	0 of 14
Aquamin® - Subjects With Ulcerative Colitis	0 of 12 (0%)	6 of 12 (50%)	0 of 12
Aquamin® - Subjects With IBS-D	0 of 3 (0%)	3 of 3 (100%)	0 of 3

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 41359652Aslam MN, Turgeon DK, Appelman HD, Stidham R, McClintock S, Allen R, Moraga G, Harber I, Jencks KJ, McNeely MM, Sen A, Jepsen KJ, Varani J. A multi-mineral intervention to improve disease-related and mechanistic biomarkers in ulcerative colitis patients: Results from a randomized trial. PLoS One. 2025 Dec 8;20(12):e0337408. doi: 10.1371/journal.pone.0337408. eCollection 2025.
Results publication: PubMed 41646788Aslam MN, Turgeon DK, McClintock S, Allen R, Sen A, Varani J. A Multi-Mineral Intervention Improves Intestinal Permeability in Patients with Ulcerative Colitis: Results from a 90-Day Pilot Trial. medRxiv [Preprint]. 2026 Jan 30:2026.01.28.26345064. doi: 10.64898/2026.01.28.26345064.
Derived from this study: PubMed 42440705Aslam MN, Turgeon DK, McClintock S, Allen R, Sen A, Varani J. A multi-mineral intervention is associated with improved intestinal permeability in patients with ulcerative colitis: results from a pilot trial. Front Med (Lausanne). 2026 Jun 22;13:1805900. doi: 10.3389/fmed.2026.1805900. eCollection 2026.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

James Varani principal investigator

University of Michigan

Muhammad N Aslam study director

University of Michigan

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Aquamin in people with Ulcerative Colitis and Healthy, run by James Varani at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04855799, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.