Healthy Full Term Infants Clinical Trial
Official title:
Effect of a Starter Formula With Synbiotics on Stool Microbiota in Infants After Normal or Caesarean Section Delivery
| Verified date | January 2014 |
| Source | Nestlé |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | South Africa: Medicines Control Council |
| Study type | Interventional |
The primary objectives of this trial are:
- to show differences in the colonization of the gastrointestinal tract with the bacteria
Bifidobacterium sp. between infants born by normal or caesarean delivery, fed with the
test or a control product
- to investigate whether there is equivalence in growth between the four different groups
of infant described above.
| Status | Terminated |
| Enrollment | 430 |
| Est. completion date | October 2013 |
| Est. primary completion date | February 2013 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | N/A to 3 Days |
| Eligibility |
Inclusion Criteria: - Healthy newborn infant from HIV positive mother - Full term infant (more or equal to 37 weeks gestation; less or equal to 42 weeks gestation) - Age of infant 3 days at the time of enrollment - Birth weight between 2500 and 4500 grams - Singleton birth - The infant's mother has elected to feed their child exclusively with a milk formula from birth - Informed consent from the parent or legal guardian Exclusion Criteria: - Congenital illness or malformation that may affect normal growth - Significant pre-natal and / or post-natal disease - Newborns who have received antibiotics during the first 3 days of life - Newborns whose parents / caregivers cannot be expected to comply with the study protocol - Newborns currently participating in another clinical trial |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
| Country | Name | City | State |
|---|---|---|---|
| South Africa | Chris Hani Baragwanath Hospital | Bertsham | |
| South Africa | Rahima Moosa Mother and Child Hospital | Johannesburg | |
| South Africa | Witswatersrand University | Johannesburg | Parktown |
| Lead Sponsor | Collaborator |
|---|---|
| Nestlé |
South Africa,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | differences in the colonization of the gastrointestinal tract with the bacteria Bifidobacterium sp. between infants born by normal or caesarean delivery, fed with the test or a control product | 3 days, 10 days, 1 month, and 3 months of age of the infant | No | |
| Primary | • Mean weight gain (g/day) | over 112 days | No | |
| Secondary | body composition by DEXA | 4 month and 12 month of life | No | |
| Secondary | Digestive tolerance (stool characteristics and frequency, vomiting, regurgitation, frequency of colic) | 10 days, 1 month, 6 weeks, 3 month and 4 month of life | No |