Elemental Formula Hypoallergenicity
This study is ongoing, but not recruiting participants.
Sponsor:
Nestlé
Information provided by (Responsible Party):
Nestlé
ClinicalTrials.gov Identifier:
NCT01569776
First received: March 30, 2012
Last updated: January 16, 2013
Last verified: January 2013
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Purpose
The primary objective of this clinical trial is to determine whether a new amino acid-based formula is hypoallergenic as defined by the American Academy of Pediatrics (2000), demonstrating that the test formula does not provoke allergenic activity in 90% of infants or children with confirmed cow's milk allergy (CMA) with 95% confidence as compared to a commercially available hypoallergenic formula.
| Condition | Intervention |
|---|---|
|
Food Hypersensitivity |
Other: Amino Acid formula Other: Commercially available Amino Acid Formula |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Evaluation of Hypoallergenicity of an Amino Acid-Based Infant Formula |
Resource links provided by NLM:
Further study details as provided by Nestlé:
Primary Outcome Measures:
- occurrence of allergic reactions [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]occurrence of allergic reactions to double-blind placebo controlled food challenge (DBPCFC)
Secondary Outcome Measures:
- Digestive Tolerance [ Time Frame: one week ] [ Designated as safety issue: No ]gastrointestinal tolerance and formula intake recorded during the open challenge phase.
| Estimated Enrollment: | 70 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | July 2013 |
| Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: New Amino Acid formula |
Other: Amino Acid formula
Amino Acid baby formula
|
|
Active Comparator: Control formula
Commercially available Amino Acid infant formula
|
Other: Commercially available Amino Acid Formula
Hypoallergenic Baby formula
|
Eligibility| Ages Eligible for Study: | 2 Months to 12 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Born at term (>36 weeks gestation)
- 2 months to ≤12 years of age at enrollment
- Documented CMA within 6 months prior to enrollment
- Otherwise healthy
- Asthma, atopic dermatitis and/or rhinitis must be well-controlled, if applicable
- Expected daily intake of at least 8 oz (240ml) of the study formula during the open challenge phase
- Having obtained his/her legal representative's informed consent
Exclusion:
- Children consuming mother's milk at the time of inclusion and during the trial
- Any chromosomal or major congenital anomalies
- Any major gastrointestinal disease or abnormalities other than CMA
- Chronic medical diseases (ie seizure disorders, chronic lung disease, heart problems (heart murmurs okay)
- Immunodeficiency
- Anti-histamine use in 7 days prior to the first food challenge (eyedrops are permitted)
- Oral steroid use within 14 days prior to enrollment (intranasal and topical corticosteroid use are permitted)
- Unstable asthma
- Severe uncontrolled eczema
- Severe anaphylactic reaction to milk within the last 2 years
- Severe anaphylactic reaction to breastmilk within the last 2 years
- Subject who in the Investigator's assessment cannot be expected to adhere to the study protocol
- Currently participating in another clinical trial.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01569776
Locations
| United States, California | |
| Pediatric Care Medical Group, Inc. | |
| Huntington Beach, California, United States, 92647 | |
| Allergy & Asthma Medical Group and Research Center, A P.C. | |
| San Diego, California, United States, 92123 | |
| United States, Georgia | |
| Georgia Pollens Clinical Research Centers Inc. | |
| Albany, Georgia, United States, 31707 | |
| United States, Illinois | |
| Allergy & Asthma Physicians | |
| Hinsdale, Illinois, United States, 60521 | |
| United States, Indiana | |
| Deaconess Clinic, Inc. | |
| Evansville, Indiana, United States, 47713 | |
| United States, New York | |
| Mount Sinai Medical Center | |
| New York, New York, United States, 10029 | |
| ENT & Allergy Associates | |
| Newburgh, New York, United States, 12550 | |
| United States, Texas | |
| TTS Research | |
| Boerne, Texas, United States, 78006 | |
| United States, Virginia | |
| Clinical Research Partners | |
| Richmond, Virginia, United States, 25233 | |
Sponsors and Collaborators
Nestlé
Investigators
| Principal Investigator: | Anna Nowak-Wegrzyn, MD | Mount Sinai Department of Pediatrics |
More Information
No publications provided
| Responsible Party: | Nestlé |
| ClinicalTrials.gov Identifier: | NCT01569776 History of Changes |
| Other Study ID Numbers: | 09.55.PED |
| Study First Received: | March 30, 2012 |
| Last Updated: | January 16, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Nestlé:
|
Cow milk allergy CMA |
Additional relevant MeSH terms:
|
Food Hypersensitivity Hypersensitivity Hypersensitivity, Immediate Immune System Diseases |
ClinicalTrials.gov processed this record on May 21, 2013