Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03176875
Recruitment Status : Unknown
Verified June 2017 by Darja Urlep, University Medical Centre Ljubljana.
Recruitment status was:  Recruiting
First Posted : June 6, 2017
Last Update Posted : June 8, 2017
Sponsor:
Information provided by (Responsible Party):
Darja Urlep, University Medical Centre Ljubljana

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.


Condition or disease Intervention/treatment Phase
Adolescent Child Diet Crohn Disease Enteral Nutrition Remission Other: ALICALM (75% of daily caloric requirements) Other: ALICALM (100% of daily caloric requirements) Not Applicable

Detailed 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Partial and Exclusive Enteral Nutrition in the Treatment of Active Childhood-onset Crohn's Disease
Actual Study Start Date : May 25, 2017
Estimated Primary Completion Date : July 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arm Intervention/treatment
Experimental: PEN group
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)
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.

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




Primary Outcome Measures :
  1. Clinical Remission [ Time Frame: 6 weeks ]
    Clinical Remission (Pediatric Crohn's Disease Activity Index <10) on an intention to treat principle after 6 weeks of therapy.


Secondary Outcome Measures :
  1. Clinical response [ Time Frame: 6 weeks ]
    - 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

  2. Mucosal healing [ Time Frame: 6-8 weeks ]
    Mucosal healing using the Simple Endoscopic Score for CD (SES-CD)

  3. Change in SES-CD [ Time Frame: At week 0 and 6 -8 weeks following enrollment ]
    Change in SES-CD from baseline to 6 weeks

  4. Changes in specific blood tests [ Time Frame: At the 1, 3 and 6 weeks visits ]
    Changes in specific blood tests such as erythrocyte sedimentation rate (ESR), C reactive protein, hemoglobin, albumin, and platelets from baseline to 6 weeks

  5. Changes in stool calprotectin concentrations [ Time Frame: At the 3 and 6 weeks visits ]
    Changes in stool calprotectin concentrations (mg/kg) from baseline to 6 weeks

  6. Changes in weight-z-scores [ Time Frame: At the 0 and 6 weeks visits ]
    Changes in weight-z-scores

  7. Changes in ITM -z-scores [ Time Frame: At the 0 and 6 weeks visits ]
    Changes in ITM -z-scores



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   4 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03176875


Contacts
Layout table for location contacts
Contact: Darja Urlep, MD, MSc 0038631646347 darja.urlep@gmail.com
Contact: Evgen Benedik, PhD 0038631745549 evgen.benedik@gmail.com

Locations
Layout table for location information
Slovenia
University Medical Centre Ljubljana Recruiting
Ljubljana, Slovenia, 1000
Contact: Darja Urlep, MD, MSc    0038631646347    darja.urlep@gmail.com   
Contact: Evgen Benedik, PhD    0038631745549    evgen.benedik@gmail.com   
Sponsors and Collaborators
University Medical Centre Ljubljana
Investigators
Layout table for investigator information
Study Chair: Rok Orel, MD, PhD University Medical Centre Ljubljana, University Children's Hospital Ljubljana, Department of gastroenterology, hepatology and nutrition
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Darja Urlep, Principal investigator, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier: NCT03176875    
Other Study ID Numbers: 20150146
First Posted: June 6, 2017    Key Record Dates
Last Update Posted: June 8, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases