Diet in Pediatric Crohn´s Disease Treated With Biologics

Hospital Italiano de Buenos Aires (Other)
Overall Status
Recruiting ID

Study Details

Study Description

Brief Summary

Cded in remission patients with high calprotectin

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Crohn's disease exclusion diet

Detailed Description

Due to the success of diet in achieving remission in mild-moderate forms of the disease, and an increasing number of patients with loss of response to available drugs despite increasing dose and pathophysiology of the disease, the aim of the present study is to evaluate whether there is response with the addition of diet therapy in patients with moderate/severe forms of CD receiving biologic therapy (infliximab or adalimumab) and presenting active disease.

Study Design

Study Type:
Anticipated Enrollment :
40 participants
Intervention Model:
Parallel Assignment
None (Open Label)
Primary Purpose:
Official Title:
Diet as Adjuvant Therapeutics in the Era of Biologics in Pediatric-onset Crohn's Disease.
Actual Study Start Date :
May 14, 2021
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Diet

Patients will do biologic treatment according to international guidelines and will do Crohns Disease Exclusion Diet( modulen- phase one ant two CDED) for 12 weeks.They will be monitored periodically by interview and physical examination by physician and nutritionist, laboratory, fecal calprotectin.

Dietary Supplement: Crohn's disease exclusion diet
Patients will receive, in addition to their normal treatment, polymeric formula + diet

No Intervention: Control

Patients with normal treatment( biologic treatment indicated for CD)

Outcome Measures

Primary Outcome Measures

  1. Number of Participants with calprotectin less than 250 at week 12 [week 12]

    Number of participants who achieve normal fecal calprotectin after the diet

  2. Level of calprotectin [week 12]

    To evaluate the change of the calprotectin value at 0 and 12 weeks in patients with or without the addition of dietary therapy.

Secondary Outcome Measures

  1. Adherence [12 weeks]

    Number of patients that were able to continue the diet and not drop out during at least the 12 weeks of the study.

Eligibility Criteria


Ages Eligible for Study:
1 Month to 18 Years
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Inclusion Criteria:
  • Patients under 18 years of age

  • With a diagnosis of CD

  • Who have completed remission induction with biologic therapy

  • Who are on maintenance biologic therapy

  • Present calprotectin values higher than the limit values established by the laboratory (higher than 250 ug/g).

Exclusion Criteria:
  • Children who are unable to receive enteral dietary intake

  • Comorbidities affecting nutritional status and/or bone metabolism, growth or pubertal development

  • Children already on special diets

Contacts and Locations


Site City State Country Postal Code
1 Hospital Italiano de Buenos Aires Buenos Aires Argentina 1199

Sponsors and Collaborators

  • Hospital Italiano de Buenos Aires


  • Principal Investigator: Marina Orsi, M.D., Hospital Italiano

Study Documents (Full-Text)

More Information


None provided.
Responsible Party:
MARIA SOLEDAD ARCUCCI, principal investigator, Hospital Italiano de Buenos Aires Identifier:
Other Study ID Numbers:
  • 5992
First Posted:
Sep 5, 2021
Last Update Posted:
Aug 16, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 16, 2022