BENITIONSClinical Trial Intelligence

GI Permeability Change in Response to Aquamin®

Phase 2 Completed NCT04855799

ConditionUlcerative Colitis, Healthy, Irritable Bowel Syndrome With Diarrhea
PhasePhase 2
SponsorJames Varani
StatusCompleted
Enrollment35 participants
InterventionsAquamin
Start dateNov 2, 2021
Completion dateMar 11, 2024
Results postedJun 8, 2026

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.

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)

Mannitol Levels in Urine Samples

90 days · mgs

Aquamin® - Healthy Subjects68.54 ± 85.03 mgs
Aquamin® - Subjects With Ulcerative Colitis110.35 ± 92.70 mgs
Aquamin® - Healthy Subjects106.95 ± 86.68 mgs
Aquamin® - Subjects With Ulcerative Colitis51.60 ± 23.30 mgs
Aquamin® - Healthy Subjects829.14 ± 497.29 mgs
Aquamin® - Subjects With Ulcerative Colitis1277.08 ± 503.40 mgs
p-value0.322

Open in BENITIONS View on ClinicalTrials.gov

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