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Step Down Approach in Children With Cow Milk Allergy (SDACMA)

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ClinicalTrials.gov Identifier: NCT03449537
Recruitment Status : Not yet recruiting
First Posted : February 28, 2018
Last Update Posted : March 1, 2018
Sponsor:
Information provided by (Responsible Party):
Roberto Berni Canani, Federico II University

Brief Summary:

Cow's milk allergy (CMA) affects up to 3% of European children. In the absence of an alternative to cow's milk, the management of CMA is based on the use of safe, affordable and nutritionally adequate formulas. In Scientific Societies Guidelines, extensively hydrolyzed casein formula (EHCF) is considered as safe first line approach for the treatment of children with CMA, whereas amino acid-based formula (AAF) is considered as second line strategy in children reacting to EHCF or as first line approach in children with CMA-induced anaphylaxis.

Few and not recent studies, involving a poorly characterized study population, suggested that up to 10% of CMA children could react to the extensively hydrolysed formulas.

It has been demonstrated that EHCF supplemented with L.rhamnosus GG (LGG) maintains hypoallergenic status and that is able to accelerate oral tolerance acquisition in children with CMA comparing with other formulas.

The purpose of this study is to investigate the feasibility of a "step-down" approach in children affected by Immunoglobulin E (IgE)-mediated CMA with the aim to evaluate the effects of EHCF + LGG on oral tolerance acquisition and on immune response and gut microbiota shaping.


Condition or disease Intervention/treatment Phase
Allergy Milk Dietary Supplement: extensively hydrolyzed casein formula + LGG Dietary Supplement: Hypoallergenic formula based on amino-acid based formula Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Evaluation of the Effects of an Extensive Casein Hydrolysate Containing the Probiotic Lactobacillus Rhamnosus GG as a Possible Step Down Approach Able to Stimulate the Acquisition of Immunological Tolerance Compared to an Amino Acid Formula in Children Affected by Cow's Milk Protein Allergy
Estimated Study Start Date : April 2018
Estimated Primary Completion Date : October 28, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
Experimental: EHCF+LGG
extensively hydrolyzed casein formula supplemented with the probiotic Lactobacillus rhamnosus GG
Dietary Supplement: extensively hydrolyzed casein formula + LGG
Hypoallergenic formula based on extensively hydrolyzed casein supplemented with the probiotic Lactobacillus rhamnosus GG

Active Comparator: AAF
hypoallergenic formula based on amino acid-based formula
Dietary Supplement: Hypoallergenic formula based on amino-acid based formula
Hypoallergenic formula for cow milk allergy treatment based on amino acids




Primary Outcome Measures :
  1. Evaluation of the tolerance rate of EHCF+LGG in CMA children treated with AAF [ Time Frame: after the first oral food challenge, i.e. after 7-15 days after inclusion ]
    tolerance to extensively hydrolyzed casein formula, i.e. the ability to eat EHCF formula (at least 100 ml/day) without sign and symptoms related to allergy


Secondary Outcome Measures :
  1. Immune tolerance acquisition to cow milk in children treated with EHCF + LGG comparing with children assuming AAF, i.e. the ability to eat cow milk (at least 100 ml/day) [ Time Frame: after 12 months of intervention ]
    Tolerance to cow milk, i.e. the ability to eat cow milk (at least 100 ml/day) without sign and symptoms related to allergy

  2. auxological parameters comparing the two groups [ Time Frame: after 6 and 12 months of intervention ]
    length (cm)

  3. body growth comparing the two groups [ Time Frame: after 6 and 12 months of intervention ]
    weight (kg)

  4. Changing in allergological screening test comparing the two groups [ Time Frame: after 6 and 12 months of intervention ]
    Determination of skin prick test value (mm)

  5. Changing in immunoglobulin comparing the two groups [ Time Frame: after 6 and 12 months of intervention ]
    Total and specific IgE and IgG4 titers (kU/l)

  6. Changing in immune response comparing the two groups [ Time Frame: after 6 and 12 months of intervention ]
    methylation status (%) of interleukin (IL)-4, IL-5, IL-13, IL-10, Interferon (INF) gamma

  7. Changing in immune status comparing the two groups [ Time Frame: after 6 and 12 months of intervention ]
    serum level (pg/ml) of interleukin (IL)-4, IL-5, IL-13, IL-10, Interferon (INF) gamma

  8. Changing in gut microbiota composition comparing the two groups [ Time Frame: after 6 and 12 months of intervention ]
    Gut microbiota composition (phyla, class, order, family, genus)

  9. Changing in short chain fatty acids comparing the two groups [ Time Frame: after 6 and 12 months of intervention ]
    Fecal short chain fatty acids determination (mM/kg stool)



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Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Infants aged <6 months
  • sure diagnosis of IgE-mediated CMA confirmed by positive oral food challenge for cow's milk and or blood Cow milk protein specific IgE>0.1kiloUnits/Liter and/or Skin Prick Testing (SPT) for milk wheal size ≥ 3mm
  • children receiving AAF for at least 4 weeks
  • full and stable remission of CMA symptoms.

Exclusion Criteria:

  • Infant aged > 6 months,
  • CMP-induced anaphylaxis,
  • evidence of non-IgE-mediated CMA,
  • other food allergies,
  • other allergic diseases,
  • eosinophilic disorders of the gastrointestinal tract,
  • chronic systemic diseases,
  • congenital cardiac defects,
  • active tuberculosis,
  • autoimmune diseases,
  • immunodeficiency,
  • chronic inflammatory bowel diseases,
  • celiac disease,
  • cystic fibrosis,
  • metabolic diseases,
  • malignancy,
  • chronic pulmonary diseases,
  • malformations of the gastrointestinal and/or respiratory tract,
  • administration of prebiotics or probiotics during the 4 weeks before enrolment,
  • use of systemic antibiotics or anti-mycotic drugs during 4 weeks before study entry;
  • investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements;
  • participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study.

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Responsible Party: Roberto Berni Canani, MD, PhD, Head of Pediatric Allergology, Federico II University
ClinicalTrials.gov Identifier: NCT03449537    
Other Study ID Numbers: 284/17
First Posted: February 28, 2018    Key Record Dates
Last Update Posted: March 1, 2018
Last Verified: February 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypersensitivity
Immune System Diseases
Caseins
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action