NCT01622426

Brief Summary

The investigators aim to assess the tolerance to a new commercially available Aaf in children affected by IgE- or non-IgE-mediated CMA.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 15, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 19, 2012

Completed
Last Updated

June 19, 2012

Status Verified

June 1, 2012

Enrollment Period

1.7 years

First QC Date

June 15, 2012

Last Update Submit

June 18, 2012

Conditions

Cow's Milk Allergy

Outcome Measures

Primary Outcomes (1)

  • Tolerance to a new free amino acid-based formula in children with IgE or non-IgE-mediated cow's milk allergy

    Consecutive patients affected by IgE- or non-IgE-mediated CMA, aged ≤ 14 years, were enrolled. Oral food challenge was carried out with increasing doses of the new Aaf (Sineall, Humana, Milan, Italy), using validated Aaf as placebo. Fecal concentrations of calprotectin (FC) and eosinophilic cationic protein (ECP) were monitored.

    about 2 year

Study Arms (2)

New formula IgE mediated testing

ACTIVE COMPARATOR

Children with IgE-mediated CMA performed oral food challenge with the new formula

Dietary Supplement: tolerance to a new aminoacid based formulaDietary Supplement: Amino acid formula

New formula non-IgE-mediated testing

ACTIVE COMPARATOR

Children with non-IgE-mediated CMA performed oral food challenge with the new formula

Dietary Supplement: tolerance to a new aminoacid based formulaDietary Supplement: Amino acid formula

Interventions

tolerance to a new aminoacid based formulaDIETARY_SUPPLEMENT

Every 20 minutes, successive doses (0.1, 0.3, 1, 3, 10, 30 and 100 mL) of placebo (the commercially available Aaf Neocate, Nutricia, Milan, Italy) or of the study formula (Sineall, Humana, Milan, Italy) were administered.

Also known as: Sineall
New formula IgE mediated testingNew formula non-IgE-mediated testing
Amino acid formulaDIETARY_SUPPLEMENT

Every 20 minutes, successive doses (0.1, 0.3, 1, 3, 10, 30 and 100 mL) of placebo (the commercially available Aaf Neocate, Nutricia, Milan, Italy) or of the study formula (Sineall, Humana, Milan, Italy) were administered.

Also known as: Sineall
New formula IgE mediated testingNew formula non-IgE-mediated testing

Eligibility Criteria

Age1 Month - 168 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Pediatric patients (≤14 years of age) with a recent diagnosis of IgE- or non-IgE-mediated CMA, confirmed by positive DBPCFC or anaphylaxis in the 2 months prior to enrollment and under good clinical control.

You may not qualify if:

  • Children with concomitant chronic systemic diseases
  • Congenital cardiac defects
  • Active tuberculosis
  • Autoimmune diseases
  • Immunodeficiency
  • Chronic inflammatory bowel diseases
  • Celiac disease
  • Cystic fibrosis
  • Metabolic diseases
  • Lactose intolerance
  • Malignancy
  • Chronic pulmonary diseases
  • Malformations of the gastrointestinal tract
  • Gastroesophageal reflux disease non-food allergy-related
  • Suspected eosinophilic gastrointestinal disorders, were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Naples Federico II

Naples, Naples, 80131, Italy

Location

Related Publications (1)

  • Berni Canani R, Nocerino R, Leone L, Di Costanzo M, Terrin G, Passariello A, Cosenza L, Troncone R. Tolerance to a new free amino acid-based formula in children with IgE or non-IgE-mediated cow's milk allergy: a randomized controlled clinical trial. BMC Pediatr. 2013 Feb 18;13:24. doi: 10.1186/1471-2431-13-24.

    PMID: 23418822DERIVED

MeSH Terms

Conditions

Milk Hypersensitivity

Condition Hierarchy (Ancestors)

Food HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Roberto Berni Canani, MD, PhD

    Federico II University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

June 15, 2012

First Posted

June 19, 2012

Study Start

October 1, 2008

Primary Completion

June 1, 2010

Study Completion

October 1, 2011

Last Updated

June 19, 2012

Record last verified: 2012-06

Locations

IT(1)