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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 November 2015 |
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Main ID: |
NCT02431377 |
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Date of registration:
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07/04/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Acceptability and GI Tolerance of an Alpha-lactalbumin-enriched Formula
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Scientific title:
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Acceptability and GI Tolerance of an Alpha-lactalbumin-enriched Formula: An Uncontrolled, Open-label, Descriptive Study |
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Date of first enrolment:
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April 2015 |
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Target sample size:
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40 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02431377 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label
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Phase:
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N/A
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Countries of recruitment
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Philippines
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Contacts
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Name:
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Elvira M Estorninos, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Asian Hospital and Medical Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Written informed consent
2. Healthy, full term, singleton infant
3. Be between 28±7 days post-natal age
4. Infants at enrollment, weight-for-age = 5th and = 95th percentile according to World
Health Organization growth tables / charts
5. Infants must be exclusively consuming and tolerating a cow's milk infant formula for
a minimum of 3 consecutive days and parent(s)/LAR must have previously made the
decision to continue to exclusively formula feed
6. Have sufficient command of Tagalog or English language to complete the informed
consent and other study documents
7. Are willing and able to fulfill the requirements of the study protocol
8. Have reached the legal age of consent in the Philippines
9. Able to be contacted by telephone throughout the study
Exclusion Criteria:
1. Infants who are receiving any amount of supplemental human milk
2. Family history of siblings with documented cow's milk protein intolerance/allergy
3. Conditions requiring infant feedings other than those specified in the protocol
Age minimum:
N/A
Age maximum:
35 Days
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Infant Formula Intolerance
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Intervention(s)
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Other: S-26 Gold
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Primary Outcome(s)
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Infant Gastrointestinal Symptom Questionnaire Composite Index Score
[Time Frame: 6 weeks]
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Secondary Outcome(s)
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Infant Toddler Quality of Life Profile
[Time Frame: 6 weeks]
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Stool Consistency Score
[Time Frame: 6 weeks]
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Infant Characteristics Questionnaire (ICQ) Profile
[Time Frame: 6 weeks]
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Baby Eating Behaviour Questionnaire Profile
[Time Frame: 6 weeks]
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Formula Intake volume
[Time Frame: 6 weeks]
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Secondary ID(s)
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14.23.INF
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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