GI Permeability Change in Response to Aquamin®

Phase 2

Completed

• Conditions: Healthy; Irritable Bowel Syndrome With Diarrhea; Ulcerative Colitis
• Interventions: Drug: Aquamin

• Registration Number: NCT04855799
• Lead Sponsor: James Varani

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.

Study Timeline

• Study First Submitted: 2021-04-20
• Study First Submitted QC: 2021-04-20
• Study First Posted: 2021-04-22
• Study Start: 2021-11-02
• Primary Completion: 2024-03-11
• Study Completion: 2024-03-25
• Disposition First Posted: 2024-10-15
• Status Verified: 2025-02
• Disposition First Submitted: 2025-02-12
• Last Update Submitted: 2025-02-12
• Last Update Posted: 2025-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Aquamin®	Aquamin	-

Primary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

University of Michigan Hospital; 🇺🇸 Ann Arbor, Michigan, United States