GI Permeability Change in Response to Aquamin®

NCT04855799 | Completed Phase 2 FDA Drug

• 1 other identifier: HUM00156676 sub-study 1
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ulcerative Colitis; Healthy; Irritable Bowel Syndrome With Diarrhea

Keywords

gastrointestinal permeability

Outcome Measures

Primary Outcomes (1)

• Change in the lactulose:mannitol ratio in urine by comparing values at 90-days (post-intervention) to baseline (pre-intervention) levels.

  Baseline (pre-intervention), 90 days (post-intervention)

Study Arms (1)

Aquamin®

EXPERIMENTAL

Drug: Aquamin

Interventions

Aquamin DRUG

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).

Also known as: Nutritional

Aquamin®

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• James Varani: lead

Study Sites (1)

University of Michigan Hospital

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Aquamin

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• James Varani

  University of Michigan

  PRINCIPAL INVESTIGATOR

• Muhammad N Aslam

  University of Michigan

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Pathology

Study Record Dates

• First Submitted: April 20, 2021
• First Posted: April 22, 2021
• Study Start: November 2, 2021
• Primary Completion: March 11, 2024
• Study Completion: March 25, 2024
• Last Updated: February 24, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)