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OpenTrials
Completed

NCT Number: NCT03236207

Hypoallergenicity Evaluation of a New Extensively Hydrolyzed Formula

Infants/children with cow's milk allergy will take part in 2 double-blinded placebo-controlled food challenges (DBPCFC) of 2 extensively hydrolyzed formulas in random order. If both food challenges are passed, subjects will be asked to consume the Test formula in an at-home open challenge for 7 days.

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Key information

Conditions

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

Age range

2 month–4 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hoag Medical Group, Huntington Beach, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Born at term (>36 weeks gestation)
  • 2 months to <4 years of age at enrollment
  • Documented CMA within 6 months prior to enrollment
  • Otherwise healthy
  • Having obtained his/her legal representative's informed consent

Exclusion criteria

  • Children consuming mother's milk at the time of inclusion and during the trial
  • Any chromosomal or major congenital anomalies
  • Chronic medical diseases (ie seizure disorders, chronic lung disease, heart problems (heart murmurs okay))
  • Immunodeficiency
  • Anaphylaxis to any food
  • Receiving free amino acid formula
  • Subject who in the Investigator's assessment cannot be expected to adhere to the study protocol
  • Currently participating in another clinical trial

Treatment and study plan

Test extensively hydrolyzed formula

Other

extensively hydrolyzed formula with HMOs

Control extensively hydrolyzed formula

Other

extensively hydrolyzed formula without HMOs

Primary outcomes

  1. allergic reaction post DBPCFC

    Time frame: 2 hours

    subjects will be observed during and for at least 2 hours after the food challenge for any allergic reaction symptoms which will be documented by investigators

Secondary outcomes

  1. stool characteristics

    Time frame: 1 week

    collected on daily diaries

  2. formula intake

    Time frame: 1 week

    amount of formula ingested daily

  3. adverse events

    Time frame: 1 week

    adverse events as reported by caregivers

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 1, 2017
Registry last updated
Jan 30, 2019

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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