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NCT Number: NCT03869905

Aquamin® as an Adjuvant Intervention for Ulcerative Colitis

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aquamin®

Drug

4 capsules per day; 2 to be taken in the morning and 2 in the evening (containing approximately 800 mg calcium/day)

Other names: Nutritional

Placebo first then Aquamin®

Drug

4 capsules per day; 2 to be taken in the morning and 2 in the evening

Other names: Maltodextrin

Primary outcomes

  1. 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.

  2. 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.

  3. 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)

  4. 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)

  5. 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 outcomes

  1. Changes in serum liver function tests

    Time frame: Up to day 180

    Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), and Alkaline Phosphatase (ALKP) assessment

Sponsors and collaborators

Lead sponsor

Muhammad N Aslam, MD

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2027
Study completion
2027
First posted
Mar 11, 2019
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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