Diet in Pediatric Crohn´s Disease Treated With Biologics

Crohn's Disease Clinical Trial

Official title:

Diet as Adjuvant Therapeutics in the Era of Biologics in Pediatric-onset Crohn's Disease.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05034458
• Other study ID #: 5992
• Status: Completed
• Phase: N/A
• Start date: May 14, 2021
• Est. completion date: June 20, 2023

Study information

• Verified date: September 2023
• Source: Hospital Italiano de Buenos Aires
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Cded in remission patients with high calprotectin

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 20, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

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

Locations

Country	Name	City	State
Argentina	Hospital Italiano de Buenos Aires	Buenos Aires

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Italiano de Buenos Aires

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with calprotectin less than 250 at week 12	Number of participants who achieve normal fecal calprotectin after the diet	week 12
Primary	Level of calprotectin	To evaluate the change of the calprotectin value at 0 and 12 weeks in patients with or without the addition of dietary therapy.	week 12
Secondary	Adherence	Number of patients that were able to continue the diet and not drop out during at least the 12 weeks of the study.	12 weeks