Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn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Status Withdrawn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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 2019
Est. primary completion date December 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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®)

Locations

Country Name City State
Canada Royal University Hospital Saskatoon Saskatchewan

Sponsors (2)

Lead Sponsor Collaborator
University of Saskatchewan Royal University Hospital Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Other Post-therapy fecal calprotectin (Cp) Proportion of subjects with a post-therapy fecal calprotectin (Cp) concentration equal or less than 150 mg/g at week 8 8 weeks
Primary 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 Proportion of clinical responders Proportion of week 8 clinical responders is defined by a Mayo Score reduction of = 3 points 8 weeks
See also
  Status Clinical Trial Phase
Recruiting NCT05702879 - Combined Microbiota and Metabolic Signature in Ulcerative Colitis Predicts Anti-Inflammatory Therapy Success
Not yet recruiting NCT05953402 - A Study of Ozanimod in Pregnant Women With Ulcerative Colitis and Their Offspring
Recruiting NCT05316584 - A Novel Remote Patient and Medication Monitoring Solution to Improve Adherence and PerSiStence With IBD Therapy N/A
Recruiting NCT03950232 - An Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis Phase 3
Completed NCT03124121 - Study of the Golimumab Exposure-Response Relationship Using Serum Trough Levels Phase 4
Not yet recruiting NCT06100289 - A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease Phase 3
Withdrawn NCT04209556 - A Study To Evaluate The Safety And Efficacy Of PF-06826647 In Participants With Moderate To Severe Ulcerative Colitis Phase 2
Terminated NCT00061282 - Clotrimazole Enemas for Pouchitis in Children and Adults Phase 1/Phase 2
Recruiting NCT04398550 - SCD vs. Mediterranean Diet Therapy in Ulcerative Colitis N/A
Recruiting NCT04314375 - Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Extended-release Tablets in Pediatric Subjects Aged 5 to 17 Years With Active, Mild to Moderate Ulcerative Colitis Phase 4
Active, not recruiting NCT04857112 - Study Evaluating Efficacy and Safety of Amiselimod (MT-1303) in Mild to Moderate Ulcerative Colitis Phase 2
Completed NCT05051943 - A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
Active, not recruiting NCT04033445 - A Study of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis Phase 2/Phase 3
Recruiting NCT05428345 - A Study of Vedolizumab SC Given to Adults With Moderate to Severe Ulcerative Colitis or Crohn's Disease in South Korea
Active, not recruiting NCT06221995 - Energy Expenditure in Patients With Ulcerative Colitis Undergoing Surgery
Recruiting NCT04767984 - Testing Atorvastatin to Lower Colon Cancer Risk in Longstanding Ulcerative Colitis Phase 2
Completed NCT02508012 - Medico-economic Evaluation of the Therapeutic Drug Monitoring of Anti-TNF-α Agents in Inflammatory Bowel Diseases N/A
Recruiting NCT06071312 - FMT in Patients With Recurrent CDI and Ulcerative Colitis: Single Infusion Versus Sequential Approach Phase 1/Phase 2
Completed NCT03760003 - Dose-Ranging Phase 2b Study of ABX464 in Moderate to Severe Ulcerative Colitis Phase 2
Not yet recruiting NCT05539625 - Mini-MARVEL - Mitochondrial Antioxidant Therapy in Ulcerative Colitis Phase 2