Clinical trial NCT02793778: Efficacy of CROWN in Repair and Maintenance of the Intestinal Mucosa in Patients With CD Receiving Anti-TNF Therapy
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Crohn's Disease
Keywords: Crohn's Disease
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
mucosal healing
inflammatory bowel disease
Medical Food
Nutritional intervention
Lead sponsor: Prometheus Laboratories
Sponsor class: INDUSTRY
Collaborators: name: Nestlé Health Science Spain
name: Nestec Ltd.
First posted: 2016-06-08
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Simple Endoscopic Score - Crohn's Disease (SES-CD)
timeFrame: Week 24
Secondary outcomes:
measure: Plasma amino acid level
timeFrame: Week 12 and at Week 24
measure: Quality of Life Score - Inflammatory Bowel Disease Questionnaire (IBDQ)
timeFrame: Weeks 12 and 24
measure: Quality of Life Score - Work Productivity Activity Index - Crohn's Disease(WPAI-CD)
timeFrame: Weeks 12 and 24
measure: Inflammatory biomarkers
timeFrame: Week 24
measure: Endoscopic response
timeFrame: Week 24
measure: Corticosteroid-free
timeFrame: Week 12
Other outcomes:
Locations:
city: Dothan
country: United States
facility: CROWN Site 0032
state: Alabama
city: Huntsville
country: United States
facility: CROWN Site 0011
state: Alabama
city: Little Rock
country: United States
facility: CROWN Site 0091
state: Arkansas
city: Los Angeles
country: United States
facility: CROWN Site 0017
state: California
city: Rialto
country: United States
facility: CROWN Site 0054
state: California
city: Ventura
country: United States
facility: CROWN Site 0013
state: California
city: Aurora
country: United States
facility: CROWN Site 0030
state: Colorado
city: Bridgeport
country: United States
facility: CROWN Site 0028
state: Connecticut
city: Washington
country: United States
facility: CROWN Site 0073
state: District of Columbia
city: Naples
country: United States
facility: CROWN Site 0096
state: Florida
city: Chicago
country: United States
facility: CROWN Site 0081
state: Illinois
city: Urbana
country: United States
facility: CROWN Site 0050
state: Illinois
city: Topeka
country: United States
facility: CROWN Site 0036
state: Kansas
city: Crestview Hills
country: United States
facility: CROWN Site 0019
state: Kentucky
city: Bastrop
country: United States
facility: CROWN Site 0002
state: Louisiana
city: Baton Rouge
country: United States
facility: CROWN Site 0003
state: Louisiana
city: Shreveport
country: United States
facility: CROWN Site 0029
state: Louisiana
city: Chevy Chase
country: United States
facility: CROWN Site 0051
state: Maryland
city: Ann Arbor
country: United States
facility: CROWN Site 0014
state: Michigan
city: Chesterfield
country: United States
facility: Crown Site 0006
state: Michigan
city: Lebanon
country: United States
facility: CROWN Site 71
state: New Hampshire
city: Great Neck
country: United States
facility: CROWN Site 0020
state: New York
city: Mineola
country: United States
facility: CROWN Site 0084
state: New York
city: Poughkeepsie
country: United States
facility: CROWN Site 0039
state: New York
city: Asheville
country: United States
facility: CROWN Site 0012
state: North Carolina
city: Chapel Hill
country: United States
facility: CROWN Site 0018
state: North Carolina
city: Raleigh
country: United States
facility: CROWN Site 0034
state: North Carolina
city: Rocky Mount
country: United States
facility: CROWN Site 0021
state: North Carolina
city: Portland
country: United States
facility: CROWN Site 0093
state: Oregon
city: Philadelphia
country: United States
facility: CROWN Site 0033
state: Pennsylvania
city: Philadelphia
country: United States
facility: CROWN Site 0040
state: Pennsylvania
city: Rapid City
country: United States
facility: CROWN Site 0094
state: South Dakota
city: Hermitage
country: United States
facility: CROWN Site 0041
state: Tennessee
city: Houston
country: United States
facility: CROWN Site 0004
state: Texas
city: Houston
country: United States
facility: CROWN Site 0086
state: Texas
city: Orem
country: United States
facility: CROWN Site 0007
state: Utah
city: Norfolk
country: United States
facility: CROWN Site 0016
state: Virginia
city: Bellevue
country: United States
facility: CROWN Site 0098
state: Washington
city: Milwaukee
country: United States
facility: CROWN Site 0009
state: Wisconsin
Study officials:
affiliation: University of Pennsylvania
name: James Lewis, M.D.
role: STUDY_CHAIR
References: