Status:
ACTIVE_NOT_RECRUITING
Aquamin® as an Adjuvant Intervention for Ulcerative Colitis
Lead Sponsor:
James Varani
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine if Aquamin® works as a potential treatment to improve symptoms and if it will induce remission in patients with mild Ulcerative Colitis and extend remission i...
Eligibility Criteria
Inclusion
- Ulcerative colitis with confirmed diagnosis by histology and endoscopy AND in stable remission for 3 months or more without therapy or with maintenance therapy (except steroids and antibiotics for 3 months) OR having a mild disease.
- A negative pregnancy test
Exclusion
- No history or diagnosis of any of the following conditions: Crohn's disease, bleeding disorders, gastrointestinal or colonic malignancy, Kidney disease, including kidney "stones" or hypercalcemia, Coagulopathy/hereditary hemorrhagic disorders/ or receiving therapeutic doses of Coumadin or heparin.
- Ingested certain medications (Calcium, Vitamin D, fiber supplements and Non-steroidal anti-inflammatory drugs - NSAIDs) within 30 days of study start.
Key Trial Info
Start Date :
August 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03869905
Start Date
August 8 2019
End Date
December 1 2027
Last Update
July 2 2025
Active Locations (1)
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1
The University of Michigan
Ann Arbor, Michigan, United States, 48109