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

NCT ID: NCT02793778

Last Updated: 2019-06-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2018-06-01

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.

Conditions

Crohn's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: EXPERIMENTAL

CROWN

Intervention Type: DRUG

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

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

Group Type: PLACEBO_COMPARATOR

CROWN Placebo

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Eligibility 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. 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nestlé Health Science Spain

INDUSTRY

Sponsor Role: collaborator

Nestec Ltd.

INDUSTRY

Sponsor Role: collaborator

Prometheus Laboratories

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James Lewis, M.D.

Role: STUDY_CHAIR

University of Pennsylvania

Locations

CROWN Site 0032

Dothan, Alabama, United States

CROWN Site 0011

Huntsville, Alabama, United States

CROWN Site 0091

Little Rock, Arkansas, United States

CROWN Site 0017

Los Angeles, California, United States

CROWN Site 0054

Rialto, California, United States

CROWN Site 0013

Ventura, California, United States

CROWN Site 0030

Aurora, Colorado, United States

CROWN Site 0028

Bridgeport, Connecticut, United States

CROWN Site 0073

Washington D.C., District of Columbia, United States

CROWN Site 0096

Naples, Florida, United States

CROWN Site 0081

Chicago, Illinois, United States

CROWN Site 0050

Urbana, Illinois, United States

CROWN Site 0036

Topeka, Kansas, United States

CROWN Site 0019

Crestview Hills, Kentucky, United States

CROWN Site 0002

Bastrop, Louisiana, United States

CROWN Site 0003

Baton Rouge, Louisiana, United States

CROWN Site 0029

Shreveport, Louisiana, United States

CROWN Site 0051

Chevy Chase, Maryland, United States

CROWN Site 0014

Ann Arbor, Michigan, United States

Crown Site 0006

Chesterfield, Michigan, United States

CROWN Site 71

Lebanon, New Hampshire, United States

CROWN Site 0020

Great Neck, New York, United States

CROWN Site 0084

Mineola, New York, United States

CROWN Site 0039

Poughkeepsie, New York, United States

CROWN Site 0012

Asheville, North Carolina, United States

CROWN Site 0018

Chapel Hill, North Carolina, United States

CROWN Site 0034

Raleigh, North Carolina, United States

CROWN Site 0021

Rocky Mount, North Carolina, United States

CROWN Site 0093

Portland, Oregon, United States

CROWN Site 0033

Philadelphia, Pennsylvania, United States

CROWN Site 0040

Philadelphia, Pennsylvania, United States

CROWN Site 0094

Rapid City, South Dakota, United States

CROWN Site 0041

Hermitage, Tennessee, United States

CROWN Site 0004

Houston, Texas, United States

CROWN Site 0086

Houston, Texas, United States

CROWN Site 0007

Orem, Utah, United States

CROWN Site 0016

Norfolk, Virginia, United States

CROWN Site 0098

Bellevue, Washington, United States

CROWN Site 0009

Milwaukee, Wisconsin, United States

Countries

United States

Other Identifiers

13.06.CLI

Identifier Type: -

Identifier Source: org_study_id