Seaweed supplement may help leaky gut in bowel disorders
NCT ID NCT04855799
First seen Jun 27, 2026 · Last updated Jul 17, 2026 · Updated 1 time
Summary
This study tested whether a seaweed-derived supplement called Aquamin® can reduce gut permeability (often called 'leaky gut') in people with ulcerative colitis, irritable bowel syndrome with diarrhea, and healthy volunteers. Thirty-five adults took Aquamin capsules for 90 days. Researchers measured changes in urine levels of mannitol, a sugar that indicates how much material passes through the gut wall. The goal was to see if Aquamin could help tighten the gut barrier.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Aquamin (a calcium-rich supplement from seaweed)
- What this could lead to
- If successful, this could point toward a dietary supplement that helps manage gut barrier function in people with ulcerative colitis or IBS-D.
- What could go wrong
- This is a small, early-phase study with only 35 participants, and it measures a biomarker (gut permeability) rather than direct symptom improvement. Results may not lead to a treatment.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
35 people
The number who actually took part.
- Started
-
Nov 2021
- Finished
-
Mar 2024
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 80 years
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
University of Michigan Hospital
Ann Arbor, Michigan, 48109, United States
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