Comparison of Partial and Exclusive Enteral Nutrition in the Treatment of Active Childhood-onset Crohn's Disease

Crohn Disease Clinical Trial

Official title:

Comparison of Partial and Exclusive Enteral Nutrition in the Treatment of Active Childhood-onset Crohn's Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03176875
• Other study ID #: 20150146
• Status: Recruiting
• Phase: N/A
• First received: May 25, 2017
• Last updated: June 6, 2017
• Start date: May 25, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: June 2017
• Source: University Medical Centre Ljubljana
• Contact: Darja Urlep, MD, MSc
• Phone: 0038631646347
• Email: darja.urlep[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Background: Exclusive enteral nutrition (EEN) is a well established method of treatment for inducing remission in childhood-onset Crohn's disease. It involves placing children on a strict diet composed only of a single polymeric formula, as the sole source of nutrition over 6 to 8 weeks. Use of this treatment method results in clinical remission in 50% to 80% of children by week 6-8.

Partial enteral nutrition (PEN) would be more acceptable to patients than EEN, and might be an effective treatment for active Crohn's disease. Moreover, there are studies suggesting that PEN may be effective for the induction of remission in pediatric patients with Crohn's disease; however, the level of evidence is still low.

Methods: This is a prospective randomized controlled trial, in patients with active childhood-onset Crohn's disease comparing two arms over 6 weeks of therapy.

Group 1 (PEN group): will receive 75% of their dietary needs from a polymeric formula (Alicalm, Nutricia) and a limited (25% of dietary needs = 1 meal per day) whole food AID-CD for 6 weeks.

Group 2 (EEN group): will receive EEN with Alicalm (Nutricia) for 6 weeks.

Patients will be seen at onset and week 1, 3, and 6.

This study will evaluate clinical response (a decrease in PCDAI score of ≥12.5 points), clinical remission (PCDAI <10) and mucosal healing using SES-CD in both groups, as well as the effects of the two nutritional approaches on the patients' nutritional status.

Antiinflammatory diet for Crohn's disease (AID-CD) is based on reducing exposure to animal fat, simple carbohydrates and processed food. We removed foods that previous research has shown to induce inflammation and added foods that have been shown to be beneficial in reducing inflammation. Our AID-CD is based on Central European and thus Slovenian local and traditional cuisine.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Adolescent
• Child
• Crohn Disease
• Diet
• Enteral Nutrition
• Remission

Intervention

Other:
• ALICALM (75% of daily caloric requirements)
PEN group will receive 75% of their daily dietary needs from a polymeric formula (Alicalm, Nutricia) and 25% of daily dietary needs (1 meal per day) from an antiinflammatory diet for CD (AID-CD) for 6 weeks.
• ALICALM (100% of daily caloric requirements)
EEN group will receive 100% of their daily dietary needs from a polymeric formula (Alicalm, Nutricia) for 6 weeks.

Locations

Country	Name	City	State
Slovenia	University Medical Centre Ljubljana	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Centre Ljubljana

Country where clinical trial is conducted

Slovenia, 

References & Publications (2)

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

Outcome

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