Status:
WITHDRAWN
Flaxseed Lignan-Enriched Complex (FLC) for the Treatment of Patients With Ulcerative Colitis (UC): A Pilot Assessment
Lead Sponsor:
University of Saskatchewan
Collaborating Sponsors:
Royal University Hospital Foundation
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study proposes to examine the effect of diet as a modifiable risk factor among patients with ulcerative colitis (UC). Flax seeds contain many bioactive constituents which have anti-oxidative, ant...
Detailed Description
This project is a single centre, randomized, placebo-controlled pilot study in which subjects recruited to the study will undergo treatment with FLC for an 8-week period. The investigators will recrui...
Eligibility Criteria
Inclusion
- Female or male aged 18 years and above
- Patients diagnosed with mild to moderately severe, left-sided or pan-colonic UC (Mayo Score 3 - 10 points)
- Baseline vitamin D status and clinically indicated laboratory investigations such as CBC, liver enzymes and serologic inflammatory marker high sensitivity c-reactive protein (hsCRP).
Exclusion
- Patients with the following conditions will be excluded:
- colectomy
- positive stool culture for common bacterial pathogens
- history of drug or alcohol abuse
- mental illness
- concomitant immunological
- hematologic or neoplastic disease
- hepatic insufficiency
- cardiac insufficiency
- pregnancy
- treatment with anti-tumor necrosis factor agents within 3 months
- local steroids in the preceding 30 days and antibiotics less than 15 days before screening
Key Trial Info
Start Date :
December 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2019
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02201758
Start Date
December 1 2018
End Date
December 1 2019
Last Update
December 5 2023
Active Locations (1)
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1
Royal University Hospital
Saskatoon, Saskatchewan, Canada, S7N 0W8