Crohn's Disease
Conditions
Keywords
Crohn's Disease, Digestive System Diseases, Gastrointestinal Diseases, Intestinal Diseases, mucosal healing, inflammatory bowel disease, Medical Food, Nutritional intervention
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.
Interventions
DRUGCROWN
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
DRUGCROWN 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
Sponsors
Nestlé Health Science Spain
Nestec Ltd.
Prometheus Laboratories
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Simple Endoscopic Score - Crohn's Disease (SES-CD) | Week 24 | Measuring intestinal health improvement is the Week 24 change from baseline in Simple Endoscopic Score - Crohn's Disease (SES-CD) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life Score - Inflammatory Bowel Disease Questionnaire (IBDQ) | 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) | Weeks 12 and 24 | Change from baseline in quality of life score in WPAI-CD |
| Plasma amino acid level | Week 12 and at Week 24 | Change from baseline in plasma amino acid levels |
| Endoscopic response | 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 | Week 12 | Proportion of subjects who are corticosteroid-free |
| Inflammatory biomarkers | Week 24 | Proportion of subjects with a normalization of inflammatory biomarkers (C-Reactive Protein (CRP) and fecal calprotectin) |
Countries
United States
Outcome results
None listed