NCT04855799

GI Permeability Change in Response to Aquamin®

Direct Measurement of Gastrointestinal Permeability Change in Response to Aquamin®

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: James Varani · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	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).

Timeline

• Start date: 2021-11-02
• Primary completion: 2024-03-11
• Completion: 2024-03-25
• First posted: 2021-04-22
• Last updated: 2025-02-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study