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

Crohn's Disease Clinical Trial

— PIONEER-CD  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02793778
• Other study ID #: 13.06.CLI
• Status: Terminated
• Phase: Phase 2
• Start date: July 2016
• Est. completion date: June 1, 2018

Study information

• Verified date: June 2019
• Source: Prometheus Laboratories
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 42
• Est. completion date: June 1, 2018
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

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
• 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

Locations

Country	Name	City	State
United States	CROWN Site 0014	Ann Arbor	Michigan
United States	CROWN Site 0012	Asheville	North Carolina
United States	CROWN Site 0030	Aurora	Colorado
United States	CROWN Site 0002	Bastrop	Louisiana
United States	CROWN Site 0003	Baton Rouge	Louisiana
United States	CROWN Site 0098	Bellevue	Washington
United States	CROWN Site 0028	Bridgeport	Connecticut
United States	CROWN Site 0018	Chapel Hill	North Carolina
United States	Crown Site 0006	Chesterfield	Michigan
United States	CROWN Site 0051	Chevy Chase	Maryland
United States	CROWN Site 0081	Chicago	Illinois
United States	CROWN Site 0019	Crestview Hills	Kentucky
United States	CROWN Site 0032	Dothan	Alabama
United States	CROWN Site 0020	Great Neck	New York
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 0011	Huntsville	Alabama
United States	CROWN Site 71	Lebanon	New Hampshire
United States	CROWN Site 0091	Little Rock	Arkansas
United States	CROWN Site 0017	Los Angeles	California
United States	CROWN Site 0009	Milwaukee	Wisconsin
United States	CROWN Site 0084	Mineola	New York
United States	CROWN Site 0096	Naples	Florida
United States	CROWN Site 0016	Norfolk	Virginia
United States	CROWN Site 0007	Orem	Utah
United States	CROWN Site 0033	Philadelphia	Pennsylvania
United States	CROWN Site 0040	Philadelphia	Pennsylvania
United States	CROWN Site 0093	Portland	Oregon
United States	CROWN Site 0039	Poughkeepsie	New York
United States	CROWN Site 0034	Raleigh	North Carolina
United States	CROWN Site 0094	Rapid City	South Dakota
United States	CROWN Site 0054	Rialto	California
United States	CROWN Site 0021	Rocky Mount	North Carolina
United States	CROWN Site 0029	Shreveport	Louisiana
United States	CROWN Site 0036	Topeka	Kansas
United States	CROWN Site 0050	Urbana	Illinois
United States	CROWN Site 0013	Ventura	California
United States	CROWN Site 0073	Washington	District of Columbia

Sponsors (3)

Lead Sponsor	Collaborator
Prometheus Laboratories	Nestec Ltd., Nestlé Health Science Spain

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Simple Endoscopic Score - Crohn's Disease (SES-CD)	Measuring intestinal health improvement is the Week 24 change from baseline in Simple Endoscopic Score - Crohn's Disease (SES-CD)	Week 24
Secondary	Plasma amino acid level	Change from baseline in plasma amino acid levels	Week 12 and at Week 24
Secondary	Quality of Life Score - Inflammatory Bowel Disease Questionnaire (IBDQ)	Change from baseline in quality of life score in IBDQ	Weeks 12 and 24
Secondary	Quality of Life Score - Work Productivity Activity Index - Crohn's Disease(WPAI-CD)	Change from baseline in quality of life score in WPAI-CD	Weeks 12 and 24
Secondary	Inflammatory biomarkers	Proportion of subjects with a normalization of inflammatory biomarkers (C-Reactive Protein (CRP) and fecal calprotectin)	Week 24
Secondary	Endoscopic response	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
Secondary	Corticosteroid-free	Proportion of subjects who are corticosteroid-free	Week 12