Aquamin® as an Adjuvant Intervention for Ulcerative Colitis In Remission

Overview

The purpose of this study is to determine if Aquamin® works as a potential treatment to improve symptoms and if it will extend remission in patients with stable Ulcerative Colitis.

Full Title of Study: “Aquamin®, a Multi-mineral Natural Product From Red Marine Algae, as an Adjuvant Intervention for Ulcerative Colitis in Remission”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 2022

Interventions

  • Drug: Aquamin®
    • 4 capsules per day; 2 to be taken in the morning and 2 in the evening (containing approximately 800 mg calcium/day)
  • Drug: Placebo first then Aquamin®
    • 4 capsules per day; 2 to be taken in the morning and 2 in the evening

Arms, Groups and Cohorts

  • Experimental: Aquamin®
    • To be taken for 180 days
  • Placebo Comparator: Placebo first then Aquamin®
    • Placebo: To be taken for the first 90 days. Aquamin®: To be taken for the last 90 days (after crossover)

Clinical Trial Outcome Measures

Primary Measures

  • Change in ulcerative colitis clinical features / presentation as measured by the Inflammatory Bowel Disease Questionnaire (IBDQ) score
    • Time Frame: Up to day 180
    • 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.
  • Change in clinical assessment /gastroenterologist’s endoscopic findings based on Ulcerative Colitis Disease Activity Index (UCDAI)/Mayo Scoring
    • Time Frame: Up to day 180
    • 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.
  • Change in Cytokine levels of the colon tissue as measured by Interleukin 8 (IL-8) levels assessed by enzyme-linked immunosorbent assay (ELISA)
    • Time Frame: Up to day 180
    • Interleukin 8 levels are measured in picograms per milliliter (pg/mL)
  • Change in serum C-reactive protein (CRP) levels as measured in a blood sample.
    • Time Frame: Up to day 180
    • Serum C-reactive protein ([CRP levels)] will be reported in milligram per deciliter (mg/dL)
  • Change in fecal calprotectin levels measured in a stool sample
    • Time Frame: Up to day 180
    • Fecal calprotectin will be reported in microgram per gram (µg/g)

Secondary Measures

  • Changes in serum liver function tests
    • Time Frame: Up to day 180
    • Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), and Alkaline Phosphatase (ALKP) assessment

Participating in This Clinical Trial

Inclusion Criteria

  • Ulcerative colitis with confirmed diagnosis by histology and endoscopy AND in stable remission for 3 months or more without therapy or with a maintenance therapy (except steroids and antibiotics for 3 months)
  • A negative pregnancy test

Exclusion Criteria

  • No history or diagnosis of any of the following conditions: Chron'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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • James Varani
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: James Varani, Professor of Pathology – University of Michigan
  • Overall Official(s)
    • James Varani, Principal Investigator, University of Michigan
  • Overall Contact(s)
    • Muhammad Nadeem Aslam, 734-936-1897, mnaslam@umich.edu

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.