Aquamin® as an Adjuvant Intervention for Ulcerative Colitis

James Varani

Status and phase: Active, not recruiting; Phase 2

Conditions: Ulcerative Colitis

Treatments: Drug: Aquamin®; Drug: Placebo first then Aquamin®

Study type: Interventional

Funder types: Other

Identifiers

NCT03869905

HUM00156676

Details and patient eligibility

About

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 in Ulcerative Colitis in remission.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups, including a placebo group

Aquamin®

Experimental group

Description:

To be taken for 180 days

Treatment:

Drug: Aquamin®

Placebo first then Aquamin®

Placebo Comparator group

Description:

Placebo: To be taken for the first 90 days. Aquamin®: To be taken for the last 90 days (after crossover)

Treatment:

Drug: Placebo first then Aquamin®

Drug: Aquamin®