Nutrition in Children With Food Allergy

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.

Study Overview

• Status: Unknown
• Conditions: Food 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.

• Study Type: Observational
• Enrollment (Anticipated): 70

Contacts and Locations

Study Locations

• Italy
  • Naples, Italy, 80131
    • Recruiting
    • University of Naples Federico II
    • Contact: roberto berni canani, MD,Phd; Email: berni@unina.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

children with a sure diagnosis of food allergy

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
different dietotherapy strategies

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in anthropometric indices after dieto-therapy intervention and nutritional counseling in children with cow's milk allergy	Anthropometric indices (z-score for weight, length and head circumference) will be collected at the enrolment (T0) and after 2 (T1), 4 (T2) and 6 months (T3) by experienced nurse unaware to of the study aims. Dietary intake will be assessed by a 3-day diary at T0 and at T3. The nutrient intake will be analyzed using a specific software. The following laboratory measurements will be also analyzed at T0 and at T3: haemoglobin, albumin, total cholesterol, triglycerides, calcium, phosphorus, zinc, fatty acids.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in nutritional status after dieto-therapy intervention and nutritional counseling in children with cow's milk allergy	Dietary intake will be assessed by a 3-day diary at T0 and at T3. The nutrient intake will be analyzed using a specific software. The following laboratory measurements will be also analyzed at T0 and at T3: haemoglobin, albumin, total cholesterol, triglycerides, calcium, phosphorus, zinc, fatty acids.	1 year
Change in time of tolerance acquisition after dieto-therapy intervention in children with cow's milk allergy.	After 12 months of dietotherapy with different formulas tolerance acquisition will be investigated performing a double blind placebo controlled oral food challenge.	1 year

Collaborators and Investigators

• Sponsor: Federico II University

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Anticipated): March 1, 2013
• Study Completion (Anticipated): March 1, 2014

Study Registration Dates

• First Submitted: April 5, 2012
• First Submitted That Met QC Criteria: April 23, 2012
• First Posted (Estimate): April 24, 2012

Study Record Updates

• Last Update Posted (Estimate): April 25, 2012
• Last Update Submitted That Met QC Criteria: April 24, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Keywords: cow's milk allergy
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Food Hypersensitivity
• Other Study ID Numbers: RBC-100789; 100789 (Other Identifier: DEPARTMENT OF PEDIATRICS UNIVERSITY OF NAPLES FEDERICO II)