Gastrointestinal Tolerance And General Health Status Of Healthy Term Infants Fed A New Infant Formula

Study Overview
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Brief Summary
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The purpose of this study is to assess stool consistency, in combination with additional health-related parameters including gastrointestinal tolerance and health-related quality of life, in a large sample of Chinese infants. We will also assess the timing of, frequency, and reasons for changes in the choice of formula or method of feeding among infants in this sample, as well as incidence of common infant illness and associated healthcare usage. Anthropometric measures and the frequency and duration of physician- and parent-reported gastrointestinal and other adverse events will be evaluated.

Detailed Description
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Parents / legally acceptable representatives of eligible infants will be invited to volunteer.

Official Title
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Gastrointestinal Tolerance And General Health Status Of Healthy Term Infants Fed A New Infant Formula: A Prospective, Observational Cohort Study In China

Conditions
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Healthy

Intervention / Treatment
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* Other: Study formula feeding
* Other: Human milk feeding
* Other: Mixed feeding


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy, term (37-42 weeks gestation), singleton infant at birth. Post-natal age between 35 and 49 days (date of birth = day 0) at time of study entry. At enrollment, weight-for-age ≥ 5th and ≤ 95th percentile according to World Health Organization growth tables / charts. Exclusion Criteria: Infants who are consuming any types/brands of formula other than the new study formula (either exclusively or in a mixed feeding regimen) at time of study enrollment. Suspected or documented severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results, and in the judgment of the investigator, would make the infant inappropriate for entry into the study.

Ages Eligible for Study
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Minimum Age: 35 Days
Maximum Age: 49 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study formula-fed only<br> | Other: Study formula feeding<br>* Infants who are exclusively fed the new study formula at time of enrollment<br>|
| Human milk-fed only<br> | Other: Human milk feeding<br>* Infants who are exclusively fed human milk at time of enrollment<br>|
| Mixed-fed using study formula only<br> | Other: Mixed feeding<br>* Infants who are exclusively fed human milk and the new study formula at time of enrollment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infant stool consistency and frequency (assessed using a 3-day stool diary) |  | Baseline | 
| Infant stool consistency and frequency (assessed using a 3-day stool diary) |  | day 15 | 
| Infant stool consistency and frequency (assessed using a 3-day stool diary) |  | day 30 | 
| Infant stool consistency and frequency (assessed using a 3-day stool diary) |  | day 45 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infant gastrointestinal tolerance (assessed using a validated, interviewer-assisted parent questionnaire) |  | Baseline | 
| Infant gastrointestinal tolerance (assessed using a validated, interviewer-assisted parent questionnaire) |  | day 18 | 
| Infant gastrointestinal tolerance (assessed using a validated, interviewer-assisted parent questionnaire) |  | day 48 | 
| Infant and parent health-related quality of life (assessed using validated parent questionnaires) |  | Baseline | 
| Infant and parent health-related quality of life (assessed using validated parent questionnaires) |  | day 48 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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infant, term birth, human milk, infant formula, breast feeding, bottle feeding, gastrointestinal tract, quality of life, infant development