Aquamin® as an Adjuvant Intervention for Ulcerative Colitis

Study Overview
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Brief Summary
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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.

Official Title
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Aquamin®, a Multi-mineral Natural Product From Red Marine Algae, as an Adjuvant Intervention for Mild Ulcerative Colitis and Ulcerative Colitis in Remission

Conditions
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Ulcerative Colitis

Intervention / Treatment
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* Drug: Aquamin®
* Drug: Placebo first then Aquamin®


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This pilot study includes individuals with mild ulcerative colitis / ulcerative colitis in remission, and is a randomized, double-blind, placebo-controlled trial with two parallel treatment groups for the first 90 days. Subjects on placebo will be crossed over to Aquamin® after the halfway visit at day 90. Subjects on Aquamin® will continue their treatment until the end.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aquamin®<br>To be taken for 180 days | Drug: Aquamin®<br>* 4 capsules per day; 2 to be taken in the morning and 2 in the evening (containing approximately 800 mg calcium/day)<br>* Other names: Nutritional;|
| Placebo Comparator: Placebo first then Aquamin®<br>Placebo: To be taken for the first 90 days. Aquamin®: To be taken for the last 90 days (after crossover) | Drug: Aquamin®<br>* 4 capsules per day; 2 to be taken in the morning and 2 in the evening (containing approximately 800 mg calcium/day)<br>* Other names: Nutritional;Drug: Placebo first then Aquamin®<br>* 4 capsules per day; 2 to be taken in the morning and 2 in the evening<br>* Other names: Maltodextrin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in ulcerative colitis clinical features / presentation as measured by the Inflammatory Bowel Disease Questionnaire (IBDQ) score | This is a self-administered questionnaire. There are 32 quality of life questions related to bowel function. Each response corresponds to a letter 'a' through 'g'. Whereas 'a' indicates high frequency and 'g' indicates minimal frequency. The total IBDQ score ranges between 32 and 224, with higher scores indicating better quality of life. | Up to day 180 | 
| Change in clinical assessment /gastroenterologist's endoscopic findings based on Ulcerative Colitis Disease Activity Index (UCDAI)/Mayo Scoring | UCDAI/Mayo Scoring consists of 4 subscales: stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscale is scored on a scale of 0 to 3, where 0= normal condition and 3 = severe disease condition. The total Mayo score ranges from 0 to 12, with higher scores indicating more severe disease. | Up to day 180 | 
| Change in Cytokine levels of the colon tissue as measured by Interleukin 8 (IL-8) levels assessed by enzyme-linked immunosorbent assay (ELISA) | Interleukin 8 levels are measured in picograms per milliliter (pg/mL) | Up to day 180 | 
| Change in serum C-reactive protein (CRP) levels as measured in a blood sample. | Serum C-reactive protein ([CRP levels)] will be reported in milligram per deciliter (mg/dL) | Up to day 180 | 
| Change in fecal calprotectin levels measured in a stool sample | Fecal calprotectin will be reported in microgram per gram (µg/g) | Up to day 180 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in serum liver function tests | Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), and Alkaline Phosphatase (ALKP) assessment | Up to day 180 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Remission