Healthy Full Term InfantsNCT02031887
Effect of a Starter Formula With Synbiotics on Stool Microbiota in Infants After Normal or Caesarean Section Delivery
A study testing formula with synbiotics and formula without synbiotics in people with Healthy Full Term Infants, run by Société des Produits Nestlé (SPN) at 3 sites in South Africa.
Trial summary
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… Read more about this study
- Who is it for?
- Ages Up to 3 daysHealthy volunteers can take part
- Conditions the study is for
- Healthy Full Term Infants
- What is being tested?
- formula with synbiotics and formula without synbiotics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 430 participants
- Where
- 3 sitesSouth Africa
- Study dates
- Oct 2008to Oct 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 3 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
South Africa3 sites
Chris Hani Baragwanath Hospital
Bertsham, 2013
Witswatersrand University
Johannesburg, Parktown, 2000
Rahima Moosa Mother and Child Hospital
Johannesburg, 2112
About this study
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.
Read the detailed description
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.
Design:
This is a controlled, double blind, randomized, multi center, clinical trial of 4 groups in parallel.
Two groups of infants (born from normal or caesarean delivery) will each consume one of 2 milk formulae.
Number of patients (to be enrolled / to be analyzed): Approximately 450 / 240 Stratification will be done by gender and delivery mode.
Description of subjects and main criteria for inclusion:
Healthy full term infants born from HIV positive mothers who have elected to feed their child exclusively with a milk formula from birth. Children born after normal or caesarean delivery will be considered separately.
- Conditions
- Healthy Full Term Infants
- Being tested
- formula with synbiotics, formula without synbiotics
- Keywords
- starter formula, stool microbiota, infants, caesarean section delivery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
formula with synbioticsDietary supplement
formula without synbioticsDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Infant starter formula with synbiotics | Experimental | Infant starter formula with synbiotics Receives: Dietary Supplement: formula with synbiotics |
| Infant formula without synbiotics | Active comparator | Infant formula without synbiotics Receives: Dietary Supplement: formula without synbiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 days, 10 days, 1 month, and 3 months of age of the infant
• Mean weight gain (g/day)
Measured: over 112 days
Secondary outcomes (2)
body composition by DEXA
Measured: 4 month and 12 month of life
Digestive tolerance (stool characteristics and frequency, vomiting, regurgitation, frequency of colic)
Measured: 10 days, 1 month, 6 weeks, 3 month and 4 month of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2014 (estimated)
- Study startOct 2008
- Primary completionFeb 2013
- Study completionOct 2013
Why it stopped: South African Health Authorities now promote that HIV positive mothers should receive anti-retroviral drugs and breastfeed their infants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Full Term InfantsStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 430 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter A Cooper, Principal investigator, Witswatersrand University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02031887
- Sponsor's protocol ID
- 07.19.INF
- Status last verified
- Jan 2014
- First submitted
- 7 Jan 2014
- Last updated
- 9 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Starter Formula With Synbiotics on Stool Microbiota in Infants After Normal or Caesarean Section Delivery
- ClinicalTrials.gov ID
- NCT02031887
- Acronym / sponsor ID
- 07.19.INF
- Conditions
- Healthy Full Term Infants
- Keywords
- starter formula, stool microbiota, infants, caesarean section delivery
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: South African Health Authorities now promote that HIV positive mothers should receive anti-retroviral drugs and breastfeed their infants.
- Enrolment
- 430 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Feb 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 9 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Design:
This is a controlled, double blind, randomized, multi center, clinical trial of 4 groups in parallel.
Two groups of infants (born from normal or caesarean delivery) will each consume one of 2 milk formulae.
Number of patients (to be enrolled / to be analyzed): Approximately 450 / 240 Stratification will be done by gender and delivery mode.
Description of subjects and main criteria for inclusion:
Healthy full term infants born from HIV positive mothers who have elected to feed their child exclusively with a milk formula from birth. Children born after normal or caesarean delivery will be considered separately.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infant starter formula with synbiotics | Experimental | Dietary Supplement: formula with synbioticsInfant starter formula with synbiotics |
| Infant formula without synbiotics | Active comparator | Dietary Supplement: formula without synbioticsInfant formula without synbiotics |
Who may qualify
- Ages
- Up to 3 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| formula with synbiotics | Dietary supplement | Infant starter formula with synbiotics |
| formula without synbiotics | Dietary supplement | Infant formula without synbiotics |
Primary outcome
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
Time frame: 3 days, 10 days, 1 month, and 3 months of age of the infant
• Mean weight gain (g/day)
Time frame: over 112 days
2 secondary outcomes
body composition by DEXA
Time frame: 4 month and 12 month of life
Digestive tolerance (stool characteristics and frequency, vomiting, regurgitation, frequency of colic)
Time frame: 10 days, 1 month, 6 weeks, 3 month and 4 month of life
Results and safety
The study was stopped early (reason given: South African Health Authorities now promote that HIV positive mothers should receive anti-retroviral drugs and breastfeed their infants.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2014.
Related trials for Healthy Full Term Infants
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Maternal Health Services, Infant, Newborn
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter A Cooper principal investigator
Witswatersrand University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing formula with synbiotics and formula without synbiotics in people with Healthy Full Term Infants, run by Société des Produits Nestlé (SPN) at 3 sites in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: South African Health Authorities now promote that HIV positive mothers should receive anti-retroviral drugs and breastfeed their infants.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 3 days, 10 days, 1 month, and 3 months of age of the infant). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2014.