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OpenTrials
Completed

NCT Number: NCT05034458

Diet in Pediatric Crohn´s Disease Treated With Biologics

Cded in remission patients with high calprotectin

Completed

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Key information

Conditions

Crohn's Disease Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

1 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Italiano de Buenos Aires

Buenos Aires, 1199, Argentina

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Crohn's disease exclusion diet

Dietary Supplement

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

Primary outcomes

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

    Time frame: week 12

    Number of participants who achieve normal fecal calprotectin after the diet

  2. Level of calprotectin

    Time frame: 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 outcomes

  1. Adherence

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hospital Italiano de Buenos Aires

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Sep 5, 2021
Registry last updated
Sep 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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