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Trial record 1 of 1 for:    13.06.cli
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Efficacy of CROWN in Repair and Maintenance of the Intestinal Mucosa in Patients With CD Receiving Anti-TNF Therapy (PIONEER-CD)

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ClinicalTrials.gov Identifier: NCT02793778
Recruitment Status : Terminated (enrollment)
First Posted : June 8, 2016
Last Update Posted : June 28, 2019
Sponsor:
Collaborators:
Nestlé Health Science Spain
Nestec Ltd.
Information provided by (Responsible Party):
Prometheus Laboratories

Tracking Information
First Submitted Date  ICMJE June 1, 2016
First Posted Date  ICMJE June 8, 2016
Last Update Posted Date June 28, 2019
Study Start Date  ICMJE July 2016
Actual Primary Completion Date June 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 3, 2016)
Simple Endoscopic Score - Crohn's Disease (SES-CD) [ Time Frame: Week 24 ]
Measuring intestinal health improvement is the Week 24 change from baseline in Simple Endoscopic Score - Crohn's Disease (SES-CD)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 3, 2016)
  • Plasma amino acid level [ Time Frame: Week 12 and at Week 24 ]
    Change from baseline in plasma amino acid levels
  • Quality of Life Score - Inflammatory Bowel Disease Questionnaire (IBDQ) [ Time Frame: Weeks 12 and 24 ]
    Change from baseline in quality of life score in IBDQ
  • Quality of Life Score - Work Productivity Activity Index - Crohn's Disease(WPAI-CD) [ Time Frame: Weeks 12 and 24 ]
    Change from baseline in quality of life score in WPAI-CD
  • Inflammatory biomarkers [ Time Frame: Week 24 ]
    Proportion of subjects with a normalization of inflammatory biomarkers (C-Reactive Protein (CRP) and fecal calprotectin)
  • Endoscopic response [ Time Frame: Week 24 ]
    Proportion of subjects with endoscopic response based on SES-CD score, defined as a decrease in the SES-CD of at least 3 points from baseline, and no worsening of either component of the PRO2 (abdominal pain or liquid or soft stool frequency)
  • Corticosteroid-free [ Time Frame: Week 12 ]
    Proportion of subjects who are corticosteroid-free
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of CROWN in Repair and Maintenance of the Intestinal Mucosa in Patients With CD Receiving Anti-TNF Therapy
Official Title  ICMJE A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Effectiveness of a Nutritional Intervention in Improving the Intestinal Mucosal Health Status in Subjects With Crohn's Disease (CD) Receiving Anti-TNF Therapy
Brief Summary The purpose of this study is to evaluate CROWN's efficacy in supporting the repair and maintenance of the intestinal mucosa of patients with moderately to severely active Crohn's Disease receiving anti-Tumor Necrosis Factor (TNF) therapy (infliximab, adalimumab, certolizumab)
Detailed Description The purpose of this study is to evaluate the effectiveness of an orally administered nutritional intervention (CROWN) in subjects with Crohn's Disease (CD) to support Standard Of Care (SOC) treatment in the repair and maintenance of the intestinal mucosa over a 24 week period. SOC is defined as having been on a stable maintenance dose of an anti-Tumor Necrosis Factor (TNF) agent within 24 weeks of its initiation.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Crohn's Disease
Intervention  ICMJE
  • Drug: CROWN
    A nutritionally based therapy, formulated as a powder, administered twice a day, preferable 1 hour before or more than 2 hours after meals, for up to 24 weeks
  • Drug: CROWN Placebo
    Placebo, formulated as a powder, administered twice a day, preferable 1 hour before or more than 2 hours after meals, for up to 24 weeks
Study Arms  ICMJE
  • Experimental: CROWN
    CROWN: A nutritionally based therapy with a high protein content, formulated as a powder. Twice a day, preferable 1 hour before or more than 2 hours after meals, for up to 24 weeks
    Intervention: Drug: CROWN
  • Placebo Comparator: CROWN Placebo
    Placebo: An appearance and volume matched formulated powder. Twice a day, preferable 1 hour before or more than 2 hours after meals, for up to 24 weeks
    Intervention: Drug: CROWN Placebo
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 Terminated
Actual Enrollment  ICMJE
 (submitted: June 8, 2018)
42
Original Estimated Enrollment  ICMJE
 (submitted: June 3, 2016)
240
Actual Study Completion Date  ICMJE June 1, 2018
Actual Primary Completion Date June 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Crohn's Disease patient who has derived clinical benefit from the Standard of Care therapy, but continues to have evidence of incomplete healing of the intestinal mucosa.

  1. Adults (18-85 years of age) with a known history of symptomatic CD confirmed by endoscopy or radiology
  2. CDAI score ≤ 350
  3. Active endoscopic disease (SES-CD score ≥ 6) documented during the study screening phase or SES-CD score ≥ 4 if isolated ileal disease
  4. On a stable dose of infliximab, adalimumab, or certolizumab therapy for 8 weeks prior to randomization as part of SOC
  5. Able to consume oral nutrition for up to 24 weeks consisting of two 4 oz (120 ml) servings daily
  6. Able to understand the informed consent process, willing to follow study instructions and likely to complete all required visits and procedures, including the use of an electronic device to collect study data, home computer or tablet and internet access to complete online food frequency questionnaire, and undergo 2 endoscopies in a 6 month period

Exclusion Criteria:

Subjects with one or more of the following criteria are excluded from participation in the study:

  1. If female, subject is pregnant, nursing, or planning to become pregnant during the study period or is of childbearing potential and unable or unwilling to use a reliable form of contraception during the study
  2. Fistula known to be contributing to diarrhea
  3. Recent or current history of bowel obstruction
  4. Stricturing disease with evidence of bowel dilation proximal to stricture on imaging
  5. Anticipated need for gastrointestinal surgical therapy in the next 6 months
  6. Current treatment with a systemic corticosteroid at dose greater than 20 mg of prednisone (or equivalent) at screening
  7. Change in any antimetabolite therapy within 8 weeks prior to randomization
  8. Current treatment with antibiotics for CD (ciprofloxacin, metronidazole) at screening
  9. Current ostomy
  10. Serious infection, neoplasia or other medical conditions which would interfere with participation in the study, in the opinion of the Investigator
  11. Evidence of Clostridium difficile infection in the previous 4 weeks
  12. History of non-compliance with clinical protocols
  13. Active participation in another CD trial or received an investigational product within the past 4 weeks
  14. Diagnosis of celiac disease
  15. Known sensitivity to milk or soy protein
  16. In the Investigator's opinion, subject has any condition or situation which makes the subject unsuitable for study participation, may put the subject at significant risk, or may confound the study results
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02793778
Other Study ID Numbers  ICMJE 13.06.CLI
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Prometheus Laboratories
Study Sponsor  ICMJE Prometheus Laboratories
Collaborators  ICMJE
  • Nestlé Health Science Spain
  • Nestec Ltd.
Investigators  ICMJE
Study Chair: James Lewis, M.D. University of Pennsylvania
PRS Account Prometheus Laboratories
Verification Date June 2019

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