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Evaluation of the Hypoallergenicity of an Extensively Hydrolyzed Formula (ALYCE)

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ClinicalTrials.gov Identifier: NCT02711163
Recruitment Status : Completed
First Posted : March 17, 2016
Last Update Posted : May 15, 2018
Sponsor:
Information provided by (Responsible Party):
United Pharmaceuticals

Brief Summary:
The aim of this study is to assess the hypoallergenicity of a new thickened extensively hydrolyzed formula, in infants with confirmed cow's milk protein allergy assessed through a double blind placebo controlled food challenge, followed by a 3-month open feeding period.

Condition or disease Intervention/treatment Phase
Cow Milk Allergy Dietary Supplement: Extensively Hydrolyzed formula Dietary Supplement: Amino acid formula Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of the Hypoallergenicity of a New Thickened Extensively Hydrolyzed Formula in Infants With Confirmed Cow's Milk Protein Allergy
Study Start Date : April 2016
Actual Primary Completion Date : August 31, 2017
Actual Study Completion Date : November 29, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
Experimental: Extensively hydrolyzed formula
Feeding extensively hydrolyzed formula
Dietary Supplement: Extensively Hydrolyzed formula
Placebo Comparator: Amino acid formula
Feeding amino acid formula
Dietary Supplement: Amino acid formula



Primary Outcome Measures :
  1. Percentage of infants tolerating the formula during a double blind placebo controlled food challenge [ Time Frame: 7 days ]

Secondary Outcome Measures :
  1. Regurgitation assessed through Vandenplas score [ Time Frame: 7, 45 and 90 days ]
  2. Vomiting (weekly frequency) [ Time Frame: 7, 45 and 90 days ]
  3. Abdominal pain (severity on a 4 level scale) [ Time Frame: 7, 45 and 90 days ]
  4. Bloating and gas (severity on a 4 level scale) [ Time Frame: 7, 45 and 90 days ]
  5. Stool consistency assessed through Bristol Stools Form Scale [ Time Frame: 7, 45 and 90 days ]
  6. Sleeping time over 24h [ Time Frame: 7, 45 and 90 days ]
  7. Stool frequency over 72h [ Time Frame: 7, 45 and 90 days ]
  8. Blood in stools (presence/absence) [ Time Frame: 7, 45 and 90 days ]
  9. Duration of crying over 24h [ Time Frame: 7, 45 and 90 days ]
  10. Respiratory symptoms (severity on a 4 level scale) [ Time Frame: 7, 45 and 90 days ]
  11. Urticaria (presence/absence) [ Time Frame: 7, 45 and 90 days ]
  12. Eczema assessed through SCORAD [ Time Frame: 7, 45 and 90 days ]
  13. Weight expressed in z scores according to the WHO Child Growth Standards [ Time Frame: 45 and 90 days ]
  14. Height expressed in z scores according to the WHO Child Growth Standards [ Time Frame: 45 and 90 days ]
  15. BMI expressed in z scores according to the WHO Child Growth Standards [ Time Frame: 45 and 90 days ]
  16. Head circumference expressed in z scores according to the WHO Child Growth Standards [ Time Frame: 45 and 90 days ]
  17. Number of patients with treatment emergent Adverse Events [ Time Frame: 7, 45 and 90 days ]


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Ages Eligible for Study:   1 Month to 36 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Main Inclusion Criteria:

Infants:

  • with cow's milk allergy confirmed by a double-blind food challenge performed in the last 2 months,
  • successfully fed an eviction diet for at least 2 weeks

Main Non-inclusion Criteria:

Infants:

  • fed with an extensively hydrolyzed formula with no improvement of the symptoms,
  • who refused to drink an extensively hydrolyzed formula anytime prior to inclusion,
  • fed a vegetable based formula
  • fed an amino acid based formula or who should be fed with an amino acid based formula according to recommendations
  • who had an anaphylactic reaction in the past

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02711163


Locations
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Italy
Umberto I university hospital
Roma, Italy
Sponsors and Collaborators
United Pharmaceuticals
Investigators
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Principal Investigator: Salvatore Cucchiara University Hospital Umberto I

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Responsible Party: United Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02711163     History of Changes
Other Study ID Numbers: UP-2014-02-ALYCE
First Posted: March 17, 2016    Key Record Dates
Last Update Posted: May 15, 2018
Last Verified: May 2018

Additional relevant MeSH terms:
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Hypersensitivity
Milk Hypersensitivity
Immune System Diseases
Food Hypersensitivity
Hypersensitivity, Immediate