GI Permeability Change in Response to Aquamin®

Direct Measurement of Gastrointestinal Permeability Change in Response to Aquamin®

Sponsors

Lead Sponsor: James Varani

Source University of Michigan
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) 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.

Overall Status Not yet recruiting
Start Date 2021-05-01
Completion Date 2023-05-01
Primary Completion Date 2022-12-01
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
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)
Enrollment 20
Condition
Intervention

Intervention Type: Drug

Intervention Name: Aquamin

Description: 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).

Arm Group Label: Aquamin®

Other Name: Nutritional

Eligibility

Criteria:

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. 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/ or receiving therapeutic doses of Coumadin or heparin - 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, ulcerative colitis 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). - Not have Coagulopathy/hereditary hemorrhagic disorders/ or receiving therapeutic doses of Coumadin or heparin. - 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.

Gender:

All

Minimum Age:

18 Years

Maximum Age:

80 Years

Healthy Volunteers:

Accepts Healthy Volunteers

Overall Official
Overall Contact

Last Name: Muhammad Nadeem Aslam

Phone: 734-936-1897

Email: [email protected]

Location
Facility: University of Michigan Hospital
Location Countries

United States

Verification Date

2021-04-01

Responsible Party

Type: Sponsor-Investigator

Investigator Affiliation: University of Michigan

Investigator Full Name: James Varani

Investigator Title: Professor of Pathology

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Aquamin®

Type: Experimental

Patient Data No
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

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