Clinical Trials Logo

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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03176875
Study type Interventional
Source University Medical Centre Ljubljana
Contact Darja Urlep, MD, MSc
Phone 0038631646347
Email darja.urlep@gmail.com
Status Recruiting
Phase N/A
Start date May 25, 2017
Completion date December 31, 2018

See also
  Status Clinical Trial Phase
Active, not recruiting NCT04046913 - The ADDapt Diet in Reducing Crohn's Disease Inflammation N/A
Recruiting NCT05169593 - Prevention of Postoperative Endoscopic Recurrence With Endoscopy-driven Versus Systematic Biological Therapy Phase 4
Recruiting NCT06116604 - Early Bowel Resection for Terminal Ileal Crohn's Disease
Recruiting NCT05627128 - A Culturally Tailored Dietary Intervention to Treat Crohn's Disease N/A
Recruiting NCT05294107 - Intestinal Organoids N/A
Recruiting NCT05316584 - A Novel Remote Patient and Medication Monitoring Solution to Improve Adherence and PerSiStence With IBD Therapy N/A
Withdrawn NCT04349449 - ENTYVIO in Bio-naive Patients With Moderate/Severe Crohn's Disease (CD) in Daily Practice
Completed NCT05051943 - A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
Completed NCT03058679 - Trial of Specific Carbohydrate and Mediterranean Diets to Induce Remission of Crohn's Disease N/A
Completed NCT02871635 - BI 695501 Versus Humira in Patients With Active Crohn's Disease: a Trial Comparing Efficacy, Endoscopic Improvement, Safety, and Immunogenicity Phase 3
Recruiting NCT04266600 - Extended Mesenteric Excision in Ileocolic Resections for Crohn's Disease N/A
Recruiting NCT04539665 - Extended Mesenteric Excision in Ileocolic Resections for Crohn's Disease. N/A
Recruiting NCT03913572 - Treatment of Perianal Disease Using Adipose-derived Stem Cells
Completed NCT03606499 - Real-world Effectiveness of Ustekinumab in Participants Suffering From Inflammatory Bowel Disease (Crohn's Disease or Ulcerative Colitis) With Extra-intestinal Manifestations or Immune-mediated Inflammatory Diseases
Completed NCT03668249 - A Study to Characterize Multidimensional Model to Predict the Course of Crohn's Disease (CD)
Terminated NCT04102111 - A Study Evaluating Participants With Moderately to Severely Active Crohn's Disease Phase 2
Recruiting NCT04997733 - Fecal Microbiota Transplantation in Crohn's Disease as Relay After Anti-TNF Withdrawal Phase 3
Recruiting NCT05906576 - Post-marketing Registry Study of Infliximab for Injection in Chinese Pediatric Crohn's Disease Patients Phase 4
Not yet recruiting NCT04502303 - 18F-FDG and 68Ga-FAPI PET/CT in Crohn's Disease Phase 2
Not yet recruiting NCT04398836 - Preoperative Nutrition for Crohn's Disease Patients Phase 3