Diet in Pediatric Crohn´s Disease Treated With Biologics

September 21, 2023 updated by: MARIA SOLEDAD ARCUCCI, Hospital Italiano de Buenos Aires

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

Cded in remission patients with high calprotectin

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1199
        • Hospital Italiano de Buenos Aires

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
week 12
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.
week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Italiano de Buenos Aires

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 14, 2021

Primary Completion (Actual)

June 1, 2023

Study Completion (Actual)

June 20, 2023

Study Registration Dates

First Submitted

June 12, 2021

First Submitted That Met QC Criteria

August 28, 2021

First Posted (Actual)

September 5, 2021

Study Record Updates

Last Update Posted (Actual)

September 25, 2023

Last Update Submitted That Met QC Criteria

September 21, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5992

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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