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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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ClinicalTrials.gov Identifier: NCT02201758
Recruitment Status : Unknown
Verified June 2018 by Sharyle Fowler, University of Saskatchewan.
Recruitment status was:  Not yet recruiting
First Posted : July 28, 2014
Last Update Posted : June 13, 2018
Sponsor:
Collaborator:
Royal University Hospital Foundation
Information provided by (Responsible Party):
Sharyle Fowler, University of Saskatchewan

Tracking Information
First Submitted Date  ICMJE July 18, 2014
First Posted Date  ICMJE July 28, 2014
Last Update Posted Date June 13, 2018
Estimated Study Start Date  ICMJE December 2018
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 25, 2014)
Complete study period [ Time Frame: 8 weeks ]
The primary outcome of interest will be the comparative proportion of subjects who complete the study at week 8.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 25, 2014)
Proportion of clinical responders [ Time Frame: 8 weeks ]
Proportion of week 8 clinical responders is defined by a Mayo Score reduction of ≥ 3 points
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 25, 2014)
Post-therapy fecal calprotectin (Cp) [ Time Frame: 8 weeks ]
Proportion of subjects with a post-therapy fecal calprotectin (Cp) concentration equal or less than 150 mg/g at week 8
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Flaxseed Lignan-Enriched Complex (FLC) for the Treatment of Patients With Ulcerative Colitis (UC): A Pilot Assessment
Official Title  ICMJE Flaxseed Lignan-enriched Complex (FLC) for the Treatment of Patients With Mild to Moderately Severe Ulcerative Colitis (UC): A Pilot Assessment.
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, 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.
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 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Flaxseed Lignan-Enriched Complex (FLC) vs. placebo
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Ulcerative Colitis
Intervention  ICMJE
  • Dietary Supplement: Flaxseed lignan-enriched complex (FLC)
    Subjects will undergo treatment with FLC for an 8-week period; participants will take 300 mg flaxseed lignan-enriched complex (FLC) taken orally twice daily
  • Other: Placebo
    Placebo will consist of unflavored whey protein (manufactured by Natural Factors®)
    Other Name: Placebo Comparator: Placebo
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Placebo will consist of unflavored whey protein (manufactured by Natural Factors®)
    Intervention: Other: Placebo
  • Experimental: flaxseed lignan-enriched complex (FLC)
    Subjects will undergo treatment with FLC for an 8-week period; participants will take 300 mg flaxseed lignan-enriched complex (FLC) taken orally twice daily
    Intervention: Dietary Supplement: Flaxseed lignan-enriched complex (FLC)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 25, 2014)
56
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02201758
Other Study ID Numbers  ICMJE Bio 14-128
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sharyle Fowler, University of Saskatchewan
Study Sponsor  ICMJE University of Saskatchewan
Collaborators  ICMJE Royal University Hospital Foundation
Investigators  ICMJE Not Provided
PRS Account University of Saskatchewan
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP