Aquamin® as an Adjuvant Intervention for Ulcerative Colitis

Phase 2Active Not RecruitingNCT03869905

Muhammad N Aslam, MD40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Enrollment

Conditions

Ulcerative Colitis

Interventions

Aquamin®DRUG

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

Placebo first then Aquamin®DRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

The University of Michigan

Ann Arbor, Michigan, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: Up to day 180

Secondary Outcomes

Changes in serum liver function tests

Data from ClinicalTrials.gov

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