Diet in Pediatric Crohn´s Disease Treated With Biologics
Cded in remission patients with high calprotectin
|Condition or Disease
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.
Arms and Interventions
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)
Primary Outcome Measures
- Number of Participants with calprotectin less than 250 at week 12 [week 12]
Number of participants who achieve normal fecal calprotectin after the diet
- 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
- 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.
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).
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
|Hospital Italiano de Buenos Aires
Sponsors and Collaborators
- Hospital Italiano de Buenos Aires
- Principal Investigator: Marina Orsi, M.D., Hospital Italiano
Study Documents (Full-Text)