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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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11 December 2023 |
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Main ID: |
NCT02201758 |
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Date of registration:
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18/07/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Flaxseed Lignan-Enriched Complex (FLC) for the Treatment of Patients With Ulcerative Colitis (UC): A Pilot Assessment
FLC&UC |
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Scientific title:
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Flaxseed Lignan-enriched Complex (FLC) for the Treatment of Patients With Mild to Moderately Severe Ulcerative Colitis (UC): A Pilot Assessment. |
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Date of first enrolment:
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December 2018 |
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Target sample size:
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0 |
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Recruitment status: |
Withdrawn |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT02201758 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Care Provider).
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Phase:
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N/A
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Countries of recruitment
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Canada
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Contacts
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Name:
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Sharyle Fowler, MD,FRCPS |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Saskatchewan |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Female or male aged 18 years and above
2. Patients diagnosed with mild to moderately severe, left-sided or pan-colonic UC (Mayo
Score 3 - 10 points)
3. 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 Criteria:
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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Ulcerative Colitis
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Intervention(s)
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Dietary Supplement: Flaxseed lignan-enriched complex (FLC)
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Other: Placebo
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Primary Outcome(s)
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Complete study period
[Time Frame: 8 weeks]
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Secondary Outcome(s)
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Proportion of clinical responders
[Time Frame: 8 weeks]
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Secondary ID(s)
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Bio 14-128
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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