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

NCT03176875 | Unknown DMC

• 1 other identifier: 20150146
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Clinical response

  6 weeks

• Mucosal healing

  6-8 weeks

• Change in SES-CD

  At week 0 and 6 -8 weeks following enrollment

• Changes in specific blood tests

  At the 1, 3 and 6 weeks visits

• Changes in stool calprotectin concentrations

  At the 3 and 6 weeks visits

Study Arms (2)

PEN group

EXPERIMENTAL

Partial enteral nutrition (PEN) group will receive 75% of their daily dietary needs from a polymeric formula (Alicalm, Nutricia) and a limited (25% of dietary needs = 1 meal per day) from an antiinflammatory diet for CD (AID-CD) for 6 weeks.

Other: ALICALM (75% of daily caloric requirements)

EEN group

ACTIVE COMPARATOR

Exclusive enteral nutrition (EEN) group will receive 100 % of their daily caloric requirements from a poymeric formula (Alicalm, Nutricia) for 6 weeks.

Other: ALICALM (100% of daily caloric requirements)

Interventions

ALICALM (75% of daily caloric requirements) OTHER

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.

PEN group

ALICALM (100% of daily caloric requirements) OTHER

EEN group will receive 100% of their daily dietary needs from a polymeric formula (Alicalm, Nutricia) for 6 weeks.

EEN group

Eligibility Criteria

• Age: 4 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (1)

University Medical Centre Ljubljana

Ljubljana, 1000, Slovenia

RECRUITING

Related Publications (3)

• 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.

  PMID: 23567777 BACKGROUND

• 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.

  PMID: 24983973 BACKGROUND

• Urlep D, Benedik E, Brecelj J, Orel R. Partial enteral nutrition induces clinical and endoscopic remission in active pediatric Crohn's disease: results of a prospective cohort study. Eur J Pediatr. 2020 Mar;179(3):431-438. doi: 10.1007/s00431-019-03520-7. Epub 2019 Nov 28.

  PMID: 31781933 DERIVED

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Rok Orel, MD, PhD

  University Medical Centre Ljubljana, University Children's Hospital Ljubljana, Department of gastroenterology, hepatology and nutrition

  STUDY CHAIR

Central Study Contacts

Darja Urlep, MD, MSc

CONTACT

0038631646347; darja.urlep@gmail.com

Evgen Benedik, PhD

CONTACT

0038631745549; evgen.benedik@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 25, 2017
• First Posted: June 6, 2017
• Study Start: May 25, 2017
• Primary Completion: July 31, 2018
• Study Completion: December 31, 2018
• Last Updated: June 8, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)