Elemental Formula Hypoallergenicity
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| ClinicalTrials.gov Identifier: NCT01569776 |
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Recruitment Status :
Completed
First Posted : April 3, 2012
Last Update Posted : June 26, 2013
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Sponsor:
Nestlé
Information provided by (Responsible Party):
Nestlé
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Brief Summary:
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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Food Hypersensitivity | Other: Amino Acid formula Other: Commercially available Amino Acid Formula | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 37 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Prevention |
| Official Title: | Evaluation of Hypoallergenicity of an Amino Acid-Based Infant Formula |
| Study Start Date : | April 2012 |
| Actual Primary Completion Date : | April 2013 |
| Actual Study Completion Date : | April 2013 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Amino acids
| Arm | Intervention/treatment |
|---|---|
| Experimental: New Amino Acid formula |
Other: Amino Acid formula
Amino Acid baby formula |
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Active Comparator: Control formula
Commercially available Amino Acid infant formula
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Other: Commercially available Amino Acid Formula
Hypoallergenic Baby formula |
Primary Outcome Measures :
- occurrence of allergic reactions [ Time Frame: 14 days ]occurrence of allergic reactions to double-blind placebo controlled food challenge (DBPCFC)
Secondary Outcome Measures :
- Digestive Tolerance [ Time Frame: one week ]gastrointestinal tolerance and formula intake recorded during the open challenge phase.
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| Ages Eligible for Study: | 2 Months to 12 Years (Child) |
| Sexes Eligible for Study: | All |
| 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.
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): 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 |
| Responsible Party: | Nestlé |
| ClinicalTrials.gov Identifier: | NCT01569776 History of Changes |
| Other Study ID Numbers: |
09.55.PED |
| First Posted: | April 3, 2012 Key Record Dates |
| Last Update Posted: | June 26, 2013 |
| Last Verified: | June 2013 |
Keywords provided by Nestlé:
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Cow milk allergy CMA |
Additional relevant MeSH terms:
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Hypersensitivity Food Hypersensitivity Immune System Diseases Hypersensitivity, Immediate |