Ulcerative Colitis
Conditions
Keywords
Remission
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.
Interventions
DRUGAquamin®
4 capsules per day; 2 to be taken in the morning and 2 in the evening (containing approximately 800 mg calcium/day)
DRUGPlacebo first then Aquamin®
4 capsules per day; 2 to be taken in the morning and 2 in the evening
Sponsors
Muhammad N Aslam, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Changes in serum liver function tests | Up to day 180 | Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), and Alkaline Phosphatase (ALKP) assessment |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMuhammad Nadeem Aslam
University of Michigan
Outcome results
None listed