Flaxseed Lignan-Enriched Complex (FLC) for the Treatment of Patients With Ulcerative Colitis (UC): A Pilot Assessment

NCT02201758 | Withdrawn

• 1 other identifier: Bio 14-128
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Ulcerative Colitis

Keywords

Inflammatory Bowel Disease (IBD); ulcerative colitis (UC); flaxseed lignan-enriched complex (FLC)

Outcome Measures

Primary Outcomes (1)

• Complete study period

  The primary outcome of interest will be the comparative proportion of subjects who complete the study at week 8.

  8 weeks

Secondary Outcomes (1)

• Proportion of clinical responders

  8 weeks

Other Outcomes (1)

• Post-therapy fecal calprotectin (Cp)

  8 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo will consist of unflavored whey protein (manufactured by Natural Factors®)

Other: Placebo

flaxseed lignan-enriched complex (FLC)

EXPERIMENTAL

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)

Interventions

Flaxseed lignan-enriched complex (FLC) DIETARY_SUPPLEMENT

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

flaxseed lignan-enriched complex (FLC)

Placebo OTHER

Placebo will consist of unflavored whey protein (manufactured by Natural Factors®)

Also known as: Placebo Comparator: Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Saskatchewan: lead
• Royal University Hospital Foundation: collaborator

Study Sites (1)

Royal University Hospital

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

MeSH Terms

Conditions

Colitis, Ulcerative; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Sharyle Fowler, MD,FRCPS

  University of Saskatchewan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Model Details: Flaxseed Lignan-Enriched Complex (FLC) vs. placebo

Study Record Dates

• First Submitted: July 18, 2014
• First Posted: July 28, 2014
• Study Start: December 1, 2018
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2019
• Last Updated: December 5, 2023

Record last verified: 2023-11

Locations

CA (1)