Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02149134
Other study ID # COMETE13
Secondary ID
Status Recruiting
Phase Phase 2
First received May 15, 2014
Last updated May 23, 2014
Start date October 2013
Est. completion date July 2014

Study information

Verified date May 2014
Source Federico II University
Contact Roberto Berni Canani, MD, PhD
Phone 0817462680
Is FDA regulated No
Health authority Italy: Ethic Committee
Study type Interventional

Clinical Trial Summary

Cow's milk protein allergy is defined as an immunological reaction to one or more milk proteins. A variety of symptoms can be suggestive for cow's milk protein allergy . Cow's milk protein allergy is suspected clinically in 5-15% of infants, while most estimates of prevalence of cow's milk protein allergy vary from only 2 to 5 %. Confusion regarding cow's milk protein allergy prevalence is often due to differences in study populations, study design and a lack of defined diagnostic criteria. The importance of defined diagnostic criteria needs to be emphasised. It precludes infants from an unnecessary diet and avoids delay in diagnosis, which can lead to malnutrition.

There are two clinical types of cow's milk protein allergy: the immediate and the delayed type. The immediate type usually presents within minutes after the ingestion of cow's milk protein with urticaria, angio-oedema, vomiting or an acute flare of atopic dermatitis and is present in slightly more than half of the patients with cow's milk protein allergy. Delayed reactions such as atopic dermatitis or gastrointestinal symptoms like proctocolitis or enteropathy usually present after hours or days.

Immunologically, cow's milk protein allergy can be IgE or non-IgE mediated. IgE mediated reactions are often of the immediate type. Non-IgE mediated reactions are often cell mediated or mixed cell and IgE mediated and are more difficult to prove by specific testing. The immunological reaction differentiates cow's milk protein allergy from other milk induced pathology such as lactose intolerance.

A variety of symptoms can be suggestive for cow's milk protein allergy although none of them is diagnostic. A good medical history remains the cornerstone for the diagnosis.

The treatment of cow's milk protein allergy is the dietary elimination of cow's milk proteins. In non-breastfed infants and children less than 2 years of age, a substitute formula is mandatory as prescribed by several international scientific societies. Extensively hydrolyzed formulas are used as therapeutic formulas. An extensively hydrolysed formula is often a whey or casein based formula in which the protein has been chopped up in smaller pieces that are less allergenic. Because of high cross-reactivity (up to 80%) and nutritional inadequacy, the use of any other animal milk or soy-based formula is precluded.The infant should be maintained on an elimination diet until the child is between 9-12 months of age or at least for 6 months, whichever occurs first. In most cases, symptoms will improve substantially within 2-4 weeks if diagnosis is correct.

According to consensus in literature, a therapeutic formula is a formula tolerated by at least 90% (with 95% confidence) of cow's milk protein allergy infants.

The aim of the investigators study is to show the efficacy, tolerance and nutritional adequacy of a newly developed thickened extensively hydrolyzed formula in infants with a proven cow's milk protein allergy. In all included patients, cow's milk protein allergy will have been diagnosed based on a double blind placebo controlled food challenge, considered as golden standard in cow's milk protein allergy diagnosis. To evaluate efficacy of the formula, the formula has to be tolerated by at least 90% (with 95% confidence) of cow's milk protein allergy infants following literature consensus. A symptom diary will be filled out for this purpose by the patients' parents or legal guardians and the patient will be followed clinically by his doctor several times during the study period.

Nutritional adequacy of the formula will be evaluated clinically by following growth and weight several times during the study period and by comparing it to the standard WHO growth curves, based on breastfed infants.


Recruitment information / eligibility

Status Recruiting
Enrollment 29
Est. completion date July 2014
Est. primary completion date July 2014
Accepts healthy volunteers No
Gender Both
Age group 1 Month to 12 Months
Eligibility Inclusion Criteria:

- between 1 and 12 months old

- having a CMPA confirmed by a double-blind placebo controlled food challenge performed in the last 3 months, or with cow's milk allergy highly suspected based on clinical symptoms ( but not confirmed. In this case, a double blind food challenge will be performed during the first 3 months following inclusion

- whose parent(s) signed the informed consent form

Exclusion Criteria:

- Infants aged less than 1 month or more than 12 months

- Infants with eosinophilic disorders of the gastrointestinal tract

- Infants mainly or exclusively breastfed, with willingness to continue breast-feeding

- Infants having a weight at inclusion < 2500g,

- Infants fed (at the time of inclusion or in the past) with an extensively hydrolyzed formula with no improvement of the symptoms,

- Infants who refused to drink an extensively hydrolyzed formula anytime prior to inclusion,

- Infants fed with a vegetable based formula ,

- Infants fed an amino acid based formula

- Infants who should be fed with an amino acid based formula according to recommendations

- Infants who had an anaphylactic reaction in the past,

- Infants presenting with any situation which, according to the investigator, may interfere with the study participation, or lead to a particular risk for the subject, such as, but not limited to , 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.

- Infants already participating in another clinical trial.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Dietary Supplement:
TeHF2013-01


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 Number of subjects tolerants to a new hypoallergenic formula demonstrated by oral food challenge with the new study formula. All subjects perform an oral food challenge with the new study formula. If the infant not react to the new hypoallergenic formula during the oral food challenge, the subjects tolerate this product and will assume it every day for 4 months, as treatment for cow's milk allergy. At the moment of oral food challenge No
See also
  Status Clinical Trial Phase
Completed NCT02738060 - The Effect of Baked Milk on Cow's Milk Allergy Phase 2
Recruiting NCT01891916 - Effect Of Lactobacillus GG on Atopic March N/A
Completed NCT01634490 - Effects of Different Dietary Regimens on Tolerance Acquisition in Children With Cow's Milk Allergy N/A
Completed NCT01622426 - Tolerance to a New Free Amino Acid-based Formula in Children With IgE or Non-IgE-mediated Cow's Milk Allergy N/A
Completed NCT02466035 - Epigenetic Effects Involved in Children With Cow's Milk Allergy (EPICMA) N/A
Completed NCT02379598 - Effect of Therapy With Aminoacid Based Formula Versus Hydrolyzed Whey Proteins in Children With Cow's Milk Allergy N/A
Completed NCT04330092 - Diagnosis of Cow's Milk Protein Allergy
Not yet recruiting NCT02081651 - Parmigiano-Reggiano Cheese as a Possible Strategy to Acquire Oral Tolerance in Children With Cow's Milk Allergy Phase 3
Completed NCT03462030 - Baked Milk Oral Immunotherapy for Cow's Milk Allergy Phase 2
Completed NCT02465905 - Oral Immunotherapy in Cow's Milk Allergy (CMA) in Children : "Petit Lait" Study N/A
Suspended NCT05731206 - Hypoallergenicity of a Hydrolyzed Protein Infant Formula N/A
Not yet recruiting NCT06456541 - Infant Formula in Infants and Children With Cow's Milk Allergy N/A
Recruiting NCT02062476 - Epigenetic Effects Elicited By Lactobacillus GG In Children With Cow's Milk Allergy Phase 2
Completed NCT01589731 - Polymerized Beta-lactoglobulin Comparative Immunoreactivity N/A
Terminated NCT02405923 - Growth, Safety and Tolerance of a Rice Protein Hydrolysate Formula in Infants With Cow's Milk Protein Allergy N/A
Terminated NCT04910373 - Extensively Hydrolyzed Infant Formula in Infants and Children With Cow's Milk Allergy N/A
Recruiting NCT01968278 - Use of Baked Milk in Oral Immunotherapy for Severe IgE-mediated Cow's Milk Protein Allergic Patients N/A
Withdrawn NCT01470768 - Evaluation of Fatty Acid Levels and Growth in Infants Fed Amino Acid Based (AA) Formulas N/A
Recruiting NCT05883384 - Validity of Cow's Milk-related Symptom Score Among Children Suspected to Have Cow's Milk Protein Alergy
Completed NCT01901380 - Cow's Milk Allergy and Functional Gastrointestinal Disorders N/A