Aquamin® as an Adjuvant Intervention for Ulcerative Colitis
- Conditions
- Ulcerative Colitis
- Interventions
- Drug: Aquamin®Drug: Placebo first then Aquamin®
- Registration Number
- NCT03869905
- Lead Sponsor
- James Varani
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 40
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Aquamin® Aquamin® To be taken for 180 days Placebo first then Aquamin® Aquamin® Placebo: To be taken for the first 90 days. Aquamin®: To be taken for the last 90 days (after crossover) Placebo first then Aquamin® Placebo first then Aquamin® Placebo: To be taken for the first 90 days. Aquamin®: To be taken for the last 90 days (after crossover)
- Primary Outcome Measures
Name Time Method Change in ulcerative colitis clinical features / presentation as measured by the Inflammatory Bowel Disease Questionnaire (IBDQ) score 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 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) 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. 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 Up to day 180 Fecal calprotectin will be reported in microgram per gram (µg/g)
- Secondary Outcome Measures
Name Time Method Changes in serum liver function tests Up to day 180 Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), and Alkaline Phosphatase (ALKP) assessment
Trial Locations
- Locations (1)
The University of Michigan
🇺🇸Ann Arbor, Michigan, United States