Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT02201758 |
| Other study ID # |
Bio 14-128 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 2018 |
| Est. completion date |
December 2019 |
Study information
| Verified date |
November 2023 |
| Source |
University of Saskatchewan |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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, anti-inflammatory, and anti-carcinogenic effects. These bioactive compounds
represent novel classes of pharmacologically active compounds which may represent new options
to treat chronic disease of the gastrointestinal tract. Participants with mild to moderately
severe UC will supplement their current medications with flaxseed lignan-enriched complex
(FLC). This is a 12 week double blind placebo controlled study with assessment throughout.
Stool and blood samples (biomarkers) as well as bowel assessment via sigmoidoscopy will be
evaluated before and after the intervention. The treatment arm consists of 300 mg FLC taken
orally twice daily.
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 recruit patients with mild to moderately severe, left-sided or pan-colonic
UC (Mayo Score 3 - 10 points). All participants will have vitamin D status evaluated at
baseline and clinically indicated laboratory investigations including complete blood count
(CBC), liver enzymes and serologic inflammatory marker high sensitivity c-reactive protein
(hsCRP). Participants will be evaluated at weeks 0, 2, 4 and 8 during the treatment period
and at week 10 at follow-up. Exclusion criteria will include a colectomy, positive stool
culture for common bacterial pathogens, a 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.
Participants may continue concomitant medications at stable dosages for at least 12 weeks
before screening (medications include mesalamine, thiopurines, methotrexate, and probiotics).
Participants will continue current medication if she/he is stable with it; no washout period
is required. FLC will be a supplement therapy; dosages of concomitant medications must be
maintained constant throughout the study.
The introduction of biologics, steroids, or antibiotics or any dose increase of existing
medication during the study will be considered a treatment failure. Subjects meeting
inclusion and exclusion criteria will be randomized by a computer-generated algorithm in a
1:1 fashion to one of two treatment arms. Treatment Arm 1 will consist of 300 mg FLC taken
orally twice daily. The 600 mg dose of FLC is based on clinical research that suggests a
minimum dose of 500 mg/day dose of FLC is tolerable and necessary to observe significant
health benefits (i.e. reduction of cardiovascular risk). The placebo will consist of
unflavored whey protein (manufactured by Natural Factors®). FLC and placebo packets will be
prepared by study personnel in the College of Pharmacy and Nutrition under the supervision of
a licensed pharmacist. Participants and investigators will be blinded to treatment
allocation.
The primary outcome of interest will be the comparative proportion of subjects who complete
the study at week 8. Secondary endpoints will include the proportion of week 8 clinical
responders (as defined by a Mayo Score reduction of ≥ 3 points) and the proportion of
subjects with a post-therapy fecal calprotectin (Cp) concentration ≤ 150 μg/g at week 8.
The study will be powered to detect the primary endpoint, which is the proportion of subjects
completing the study at week 8 in the FLC versus the placebo-treated group. Power
calculations based upon a two-sided 95% confidence interval (α = 0.05) with an estimated
study completion rate of 0.40 in the placebo-treated group and 0.80 in the FLC treated group
indicate that 28 subjects will need to be recruited per group in order to detect a difference
(β = 0.80). Relevant covariates including smoking status, gender, age, disease duration and
disease severity will be compared between intervention and placebo groups using the χ2 test
of independence for categorical variables and ANOVA for continuous variables. Missing data
will be handled through multiple imputation techniques with appropriate sensitivity analysis
to investigate the effects of different imputation methods.
The use of the FLC complex holds promise in attenuating inflammation found in IBD. The
investigators suspect that using FLC in patients with mild to moderately severe UC will be
well-tolerated and efficacious. Data derived from this pilot study will inform planned future
national, double-blind, placebo-controlled intervention trials on the therapeutic potential
of flaxseed derived products in IBD and will be the first study of its kind to investigate
FLC as therapy in IBD.
The data derived from this pilot study will help to determine whether flaxseed derived
bioactive is a safe and cost-effective alternative therapeutic option for the treatment of
patients with IBD.
