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Trial record 1 of 1 for:    NCT02793778 | Recruiting, Not yet recruiting Studies
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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 : Recruiting
First Posted : June 8, 2016
Last Update Posted : October 27, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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)

Condition or disease Intervention/treatment Phase
Crohn's Disease Drug: CROWN Drug: CROWN Placebo Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : July 2016
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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
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
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
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


Outcome Measures

Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Plasma amino acid level [ Time Frame: Week 12 and at Week 24 ]
    Change from baseline in plasma amino acid levels

  2. 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

  3. 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

  4. Inflammatory biomarkers [ Time Frame: Week 24 ]
    Proportion of subjects with a normalization of inflammatory biomarkers (C-Reactive Protein (CRP) and fecal calprotectin)

  5. 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)

  6. Corticosteroid-free [ Time Frame: Week 12 ]
    Proportion of subjects who are corticosteroid-free


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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. Treatment with a topical rectal 5-aminosalicylic acid or topical rectal steroids within 2 weeks prior to screening
  8. Change in any antimetabolite therapy within 8 weeks prior to randomization
  9. Current treatment with antibiotics for CD (ciprofloxacin, metronidazole) at screening
  10. Current ostomy
  11. Serious infection, neoplasia or other medical conditions which would interfere with participation in the study, in the opinion of the Investigator
  12. Evidence of Clostridium difficile infection in the previous 4 weeks
  13. History of non-compliance with clinical protocols
  14. Active participation in another CD trial or received an investigational product within the past 4 weeks
  15. Diagnosis of celiac disease
  16. Known sensitivity to milk or soy protein
  17. 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
Contacts and Locations

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): NCT02793778


Contacts
Contact: Patricia Yen 858 768-2260 Patricia.Yen@RobartsInc.com

  Show 43 Study Locations
Sponsors and Collaborators
Prometheus Laboratories
Nestlé Health Science Spain
Nestec Ltd.
Robarts Clinical Trials Inc.
Investigators
Study Chair: James Lewis, M.D. University of Pennsylvania
More Information

Responsible Party: Prometheus Laboratories
ClinicalTrials.gov Identifier: NCT02793778     History of Changes
Other Study ID Numbers: 13.06.CLI
First Posted: June 8, 2016    Key Record Dates
Last Update Posted: October 27, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Prometheus Laboratories:
Crohn's Disease
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
mucosal healing
inflammatory bowel disease
Medical Food
Nutritional intervention

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases