Nutrition in Children With Food Allergy

NCT ID: NCT01583907

Last Updated: 2012-04-25

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 70 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2014-03-31

Brief Summary

The investigators aim to asses the effect of dieto-therapy and of nutritional counseling on the nutritional status, body growth and tolerance acquisition in children with cow's milk allergy.

Detailed Description

Prospective controlled study including patients with cow's milk allergy(6-36 months of age.During the first examination, the diagnosis will be assessed by pediatricians with great experience in food allergy, checking that the patient had undergone a standardized procedure. All cases with an unclear diagnosis of FA (i.e., lack of careful medical history, laboratory studies, and oral food challenge) or on incorrect exclusion diet (i.e., assumption of at least traces of the food allergen) will be excluded. Children with a positive history for prematurity, systemic diseases, renal failure, neurological impairment, active tuberculosis, autoimmune diseases, immunodeficiency, chronic inflammatory bowel diseases, celiac disease, cystic fibrosis, metabolic or endocrine diseases, malignancy and malformation of the gastrointestinal or the urinary tract will be also excluded. The history of each patient will be evaluated and the results of FA screening tests (i.e., skin prick tests and atopy patch tests) and of oral food challenge, together with all demographic and clinical information will be registered into a specific clinical chart. At enrolment (T0), after 2 (T1),4 (T2), 6(T3)and 12 months (T4) weight, length or height and head circumference were measured by experienced nurse unaware of the study aims using standardized procedures. The anthropometric indices (z-score for weight, z-score for length/height, z-score for head circumference) will be also evaluated for all study subjects. Anthropometric measurements will be compared with the Euro-Growth References Charts. At the end of the first visit the parents of all children taking part in the study will be asked to fill a 3-day diet record report in a form of a printed chart. Written informed consent will be obtained from parents of each child enrolled in the study.

Nutritional counseling Enrolled subjects will be evaluated by registered dieticians with a wide experience in pediatric FA, blinded to the study aims, assessing the results of the 3-day diary dietary intake at enrollment (T0), at 6 months (T3) and 12 months (T4). All diaries will be collected and analyzed using a specific software based on the Italian food composition tables. The dieticians will evaluate the results of the 3-day diary and will give information to the parents about issues potentially arising during dietary elimination and on how to replace the allergen in the diet with alternative food items equivalent on the nutritional standpoint according to specific dietary recommended intake (DRI) for Italian children for age and sex .The nutritional counseling will be also focused on feeding behaviors, selection pleasant food and children preferences. No nutritional support products will be prescribed. This is the standard procedure in the management of FA in the centers involved in the study.

Laboratory measurements At the enrollment and after 6 months (T3) after nutritional intervention a venous blood sample will be collected from children with FA on elimination diet. The following laboratory measurements will be analyzed through standardized procedures: hemoglobin, albumin, total cholesterol, triglycerides, calcium, phosphorus, and zinc.

To investigate the patients rate of tolerance acquisition after 12 months of exclusion diet an oral food challenge (OFC) will be performed.

Conditions

Food Allergy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

different dietotherapy strategies

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Patients 6-36 months of age with a suspected FA

Exclusion Criteria

• Unconfirmed diagnosis of FA
• Prematurity
• Systemic disease
• Renal failure
• Neurological impairment
• Active tuberculosis
• Autoimmune diseases
• Immunodeficiency
• Chronic inflammatory bowel diseases
• Celiac disease
• Cystic fibrosis
• Metabolic or endocrine diseases
• Malignancy
• Malformation of the gastrointestinal or the urinary tract

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 36 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federico II University

OTHER

Sponsor Role: lead

Responsible Party

Roberto Berni Canani

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

university of naples federico II

Naples, Naples, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

roberto berni canani, MD,PhD

Role: CONTACT

berni@unina.it

Facility Contacts

roberto berni canani, MD,Phd

Role: primary

berni@unina.it

Other Identifiers

100789

Identifier Type: OTHER

Identifier Source: secondary_id

RBC-100789

Identifier Type: -

Identifier Source: org_study_id