Nutrition in Children With Food Allergy

Food Allergy Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01583907
• Other study ID #: RBC-100789
• Secondary ID: 100789
• Status: Recruiting
• Phase: Phase 0
• First received: April 5, 2012
• Last updated: April 24, 2012
• Start date: March 2012
• Est. completion date: March 2014

Study information

• Verified date: April 2012
• Source: Federico II University
• Contact: roberto berni canani, MD,PhD
• Email: berni[@]unina.it
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: March 2014
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 36 Months

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Food Allergy
• Food Hypersensitivity
• Hypersensitivity

Locations

Country	Name	City	State
Italy	university of naples federico II	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No