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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

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.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Dietary Supplement: Flaxseed lignan-enriched complex (FLC) Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Flaxseed Lignan-Enriched Complex (FLC) vs. placebo
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Flaxseed Lignan-enriched Complex (FLC) for the Treatment of Patients With Mild to Moderately Severe Ulcerative Colitis (UC): A Pilot Assessment.
Estimated Study Start Date : December 2018
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo will consist of unflavored whey protein (manufactured by Natural Factors®)
Other: Placebo
Placebo will consist of unflavored whey protein (manufactured by Natural Factors®)
Other Name: Placebo Comparator: 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
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Proportion of clinical responders [ Time Frame: 8 weeks ]
    Proportion of week 8 clinical responders is defined by a Mayo Score reduction of ≥ 3 points


Other Outcome Measures:
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02201758


Contacts
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Contact: Sharyle Fowler, MD,FRCPS 306-844-1125 sharyle.fowler@usask.ca

Locations
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Canada, Saskatchewan
Royal University Hospital
Saskatoon, Saskatchewan, Canada, S7N 0W8
Contact: Sharyle Fowler, MD    306-844-1125    sharyle.fowler@usask.ca   
Sub-Investigator: Jennifer Jones, MD, Msc         
Principal Investigator: Sharyle Fowler, MD         
Sub-Investigator: Jane Alcorn, PhD         
Sub-Investigator: Gordon Zello, PhD         
Sub-Investigator: Martin Reaney, PhD         
Sub-Investigator: Juan-Nicolas Pena-Sanchez, MD, PhD         
Sponsors and Collaborators
University of Saskatchewan
Royal University Hospital Foundation
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Responsible Party: Sharyle Fowler, M.D., University of Saskatchewan
ClinicalTrials.gov Identifier: NCT02201758    
Other Study ID Numbers: Bio 14-128
First Posted: July 28, 2014    Key Record Dates
Last Update Posted: June 13, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sharyle Fowler, University of Saskatchewan:
Inflammatory Bowel Disease (IBD), ulcerative colitis (UC), flaxseed lignan-enriched complex (FLC)
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases