Crohn Disease Clinical Trial
Official title:
Comparison of Partial and Exclusive Enteral Nutrition in the Treatment of Active Childhood-onset Crohn's Disease
The primary objective of this study is to determine the efficacy of a novel enteral
nutrition (EN) protocol (delivering 75% of patient's caloric needs through EN) for induction
of remission in patients with active childhood-onset Crohn's disease (CD) and compare it to
the standard protocol with exclusive enteral nutrition (EEN). This novel approach allows
patients to consume remaining calories (25%) from an antiinflammatory diet for CD (AID-CD).
The hypothesis is that no significant difference in the remission rate between the novel EN
protocol with partial enteral nutrition (PEN) and standard protocol with EEN will be
observed.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | December 31, 2018 |
Est. primary completion date | July 31, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 4 Years to 30 Years |
Eligibility |
Inclusion Criteria: - Children (4 - 18 years of age) - Young adults (>18 and = 30 years of age) with childhood-onset CD (the diagnosis of CD before 18 years of age) - Assured diagnosis of Crohn's disease according to the Porto criteria - Patients with Active CD (Pediatric Crohn's Disease Activity Index (PCDAI) =10 in children or Harvey-Bradshaw Index (HBI) >3 in young adults ) - Patients with new-onset CD and patients with active disease despite stable doses of concomitant therapy with immunomodulators (thiopurines, methotrexate, tacrolimus) for = 3 months, on stable doses of biologic therapy (anti-TNF-a agents) for = 2 months - Patients will not be excluded if they start therapy with thiopurine concurrently, as thiopurines are not considered sufficient to induce remission in active disease before 8 weeks - Written consent of the patient and/or the legal guardian Exclusion Criteria: - Patients with no disease activity ( PCDAI <10) - Patients who have received corticosteroids of any kind in the previous 4 weeks. - Patients with penetrating disease (abscess or fistula) - Active Perianal disease - Active Extraintestinal disease - Sclerosing Cholangitis - Patients with fixed stricture or small bowel obstruction - If the patients had received any other medication for inducing remission such as steroids and/or antibiotics - No consent of the patient and/or the legal guardian |
Country | Name | City | State |
---|---|---|---|
Slovenia | University Medical Centre Ljubljana | Ljubljana |
Lead Sponsor | Collaborator |
---|---|
University Medical Centre Ljubljana |
Slovenia,
Gupta K, Noble A, Kachelries KE, Albenberg L, Kelsen JR, Grossman AB, Baldassano RN. A novel enteral nutrition protocol for the treatment of pediatric Crohn's disease. Inflamm Bowel Dis. 2013 Jun;19(7):1374-8. doi: 10.1097/MIB.0b013e318281321b. — View Citation
Sigall-Boneh R, Pfeffer-Gik T, Segal I, Zangen T, Boaz M, Levine A. Partial enteral nutrition with a Crohn's disease exclusion diet is effective for induction of remission in children and young adults with Crohn's disease. Inflamm Bowel Dis. 2014 Aug;20(8):1353-60. doi: 10.1097/MIB.0000000000000110. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical Remission | Clinical Remission (Pediatric Crohn's Disease Activity Index <10) on an intention to treat principle after 6 weeks of therapy. | 6 weeks | |
Secondary | Clinical response | - Clinical response defined as a decrease in Pediatric Crohn's Disease Activity Index score of =12.5 points) for children or a drop in HBI of at least 2 points in young adults | 6 weeks | |
Secondary | Mucosal healing | Mucosal healing using the Simple Endoscopic Score for CD (SES-CD) | 6-8 weeks | |
Secondary | Change in SES-CD | Change in SES-CD from baseline to 6 weeks | At week 0 and 6 -8 weeks following enrollment | |
Secondary | Changes in specific blood tests | Changes in specific blood tests such as erythrocyte sedimentation rate (ESR), C reactive protein, hemoglobin, albumin, and platelets from baseline to 6 weeks | At the 1, 3 and 6 weeks visits | |
Secondary | Changes in stool calprotectin concentrations | Changes in stool calprotectin concentrations (mg/kg) from baseline to 6 weeks | At the 3 and 6 weeks visits | |
Secondary | Changes in weight-z-scores | Changes in weight-z-scores | At the 0 and 6 weeks visits | |
Secondary | Changes in ITM -z-scores | Changes in ITM -z-scores | At the 0 and 6 weeks visits |
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