Efficacy of CROWN in Repair and Maintenance of the Intestinal Mucosa in Patients With CD Receiving Anti-TNF Therapy (PIONEER-CD)

June 26, 2019 updated by: Prometheus Laboratories

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

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)

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Dothan, Alabama, United States, 36305
        • CROWN Site 0032
      • Huntsville, Alabama, United States, 35801
        • CROWN Site 0011
    • Arkansas
      • Little Rock, Arkansas, United States, 72212
        • CROWN Site 0091
    • California
      • Los Angeles, California, United States, 90033
        • CROWN Site 0017
      • Rialto, California, United States, 92377
        • CROWN Site 0054
      • Ventura, California, United States, 93003
        • CROWN Site 0013
    • Colorado
      • Aurora, Colorado, United States, 80045
        • CROWN Site 0030
    • Connecticut
      • Bridgeport, Connecticut, United States, 06606
        • CROWN Site 0028
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • CROWN Site 0073
    • Florida
      • Naples, Florida, United States, 34102
        • CROWN Site 0096
    • Illinois
      • Chicago, Illinois, United States, 60611
        • CROWN Site 0081
      • Urbana, Illinois, United States, 61801
        • CROWN Site 0050
    • Kansas
      • Topeka, Kansas, United States, 66606
        • CROWN Site 0036
    • Kentucky
      • Crestview Hills, Kentucky, United States, 41017
        • CROWN Site 0019
    • Louisiana
      • Bastrop, Louisiana, United States, 71220
        • CROWN Site 0002
      • Baton Rouge, Louisiana, United States, 70809
        • CROWN Site 0003
      • Shreveport, Louisiana, United States, 71105
        • CROWN Site 0029
    • Maryland
      • Chevy Chase, Maryland, United States, 20815
        • CROWN Site 0051
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • CROWN Site 0014
      • Chesterfield, Michigan, United States, 48047
        • Crown Site 0006
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • CROWN Site 71
    • New York
      • Great Neck, New York, United States, 11021
        • CROWN Site 0020
      • Mineola, New York, United States, 11501
        • CROWN Site 0084
      • Poughkeepsie, New York, United States, 12601
        • CROWN Site 0039
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • CROWN Site 0012
      • Chapel Hill, North Carolina, United States, 27599
        • CROWN Site 0018
      • Raleigh, North Carolina, United States, 27612
        • CROWN Site 0034
      • Rocky Mount, North Carolina, United States, 27804
        • CROWN Site 0021
    • Oregon
      • Portland, Oregon, United States, 97210
        • CROWN Site 0093
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • CROWN Site 0033
      • Philadelphia, Pennsylvania, United States, 19140
        • CROWN Site 0040
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • CROWN Site 0094
    • Tennessee
      • Hermitage, Tennessee, United States, 37076
        • CROWN Site 0041
    • Texas
      • Houston, Texas, United States, 77030
        • CROWN Site 0004
      • Houston, Texas, United States, 77030
        • CROWN Site 0086
    • Utah
      • Orem, Utah, United States, 84058
        • CROWN Site 0007
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • CROWN Site 0016
    • Washington
      • Bellevue, Washington, United States, 98004
        • CROWN Site 0098
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • CROWN Site 0009

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
Week 24

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Plasma amino acid level
Time Frame: Week 12 and at Week 24
Change from baseline in plasma amino acid levels
Week 12 and at Week 24
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
Weeks 12 and 24
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
Weeks 12 and 24
Inflammatory biomarkers
Time Frame: Week 24
Proportion of subjects with a normalization of inflammatory biomarkers (C-Reactive Protein (CRP) and fecal calprotectin)
Week 24
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)
Week 24
Corticosteroid-free
Time Frame: Week 12
Proportion of subjects who are corticosteroid-free
Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Prometheus Laboratories

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Nestlé Health Science Spain
Nestec Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: James Lewis, M.D., University of Pennsylvania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 1, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 8, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 28, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 13.06.CLI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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