GI Permeability Change in Response to Aquamin®

NCT ID: NCT04855799

Last Updated: 2025-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-02
• Study Completion Date: 2024-03-25

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Aquamin®

Group Type: EXPERIMENTAL

Aquamin

Intervention Type: 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).

Interventions

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).

Intervention Type: DRUG

Other Intervention Names

Nutritional

Eligibility Criteria

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.
• 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

• 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
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

James Varani

OTHER

Sponsor Role: lead

Responsible Party

James Varani

Professor of Pathology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

James Varani

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Muhammad N Aslam

Role: STUDY_DIRECTOR

University of Michigan

Locations

University of Michigan Hospital

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

HUM00156676 sub-study 1

Identifier Type: -

Identifier Source: org_study_id