Diet in Pediatric Crohn´s Disease Treated With Biologics

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05034458

Enrollment

Registered

2021-09-05

Start date

2021-05-14

Completion date

2023-06-20

Last updated

2023-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's Disease

Brief summary

Cded in remission patients with high calprotectin

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.

Interventions

DIETARY_SUPPLEMENTCrohn's disease exclusion diet

Patients will receive, in addition to their normal treatment, polymeric formula + diet

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Months to 18 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Argentina

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026