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Completed

NCT Number: NCT02711163

Evaluation of the Hypoallergenicity of an Extensively Hydrolyzed Formula

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.

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Key information

Conditions

Cow Milk Allergy Food Hypersensitivity Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Milk Hypersensitivity

Age range

1 month–36 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Umberto I university hospital

Roma, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Extensively Hydrolyzed formula

Dietary Supplement

Amino acid formula

Dietary Supplement

Primary outcomes

  1. Percentage of infants tolerating the formula during a double blind placebo controlled food challenge

    Time frame: 7 days

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

United Pharmaceuticals

Industry

Registry information

Official study title

Evaluation of the Hypoallergenicity of a New Thickened Extensively Hydrolyzed Formula in Infants With Confirmed Cow's Milk Protein Allergy

Acronym: ALYCE

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 17, 2016
Registry last updated
May 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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