Diet in Pediatric Crohn´s Disease Treated With Biologics

Study Purpose

Cded in remission patients with high calprotectin

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 1 Month - 18 Years
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05034458
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Hospital Italiano de Buenos Aires
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Marina Orsi, M.D.
Principal Investigator Affiliation Hospital Italiano
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Argentina
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Crohn's Disease
Additional Details

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 & Interventions

Arms

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.

No Intervention: Control

Patients with normal treatment( biologic treatment indicated for CD)

Interventions

Dietary Supplement: - Crohn's disease exclusion diet

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Hospital Italiano de Buenos Aires, Buenos Aires, Argentina

Status

Recruiting

Address

Hospital Italiano de Buenos Aires

Buenos Aires, , 1199