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Oral Supplement for Pregnant and Lactating Mothers

This study has been completed.
Sponsor:
Collaborator:
University of the Philippines
Information provided by (Responsible Party):
Nestlé
ClinicalTrials.gov Identifier:
NCT01073033
First received: February 17, 2010
Last updated: September 25, 2012
Last verified: September 2012

February 17, 2010
September 25, 2012
April 2010
April 2012   (final data collection date for primary outcome measure)
The incidence of diarrhea in infants from birth to 1 year [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01073033 on ClinicalTrials.gov Archive Site
  • In infants: growth, morbidity, immune maturation, metabolomics profile [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • In mothers: fetal growth, general health, immune system, metabolomics profile and preterm delivery [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Oral Supplement for Pregnant and Lactating Mothers
Oral Supplement for Pregnant and Lactating Mothers to Promote Infant Immune Maturation and Protection Against Early Life Infections

To assess protection against early life infections through supplementation of mothers during pregnancy to the newborns' growth, morbidity, immune status intra and extra-uterine.

During pregnancy mothers have to fulfill the tremendous physiological needs to support their own immune status as well as that of their babies. Accordingly, it appears highly valuable to provide mothers with a nutritional supplement during pregnancy and lactation to promote the immune development in newborns, thus reinforcing the infants' defenses.

In that respect, an appropriate maternal diet must provide sufficient energy and nutrients to meet the mother's usual requirements and promote health status, as well as the needs of the growing fetus and beyond for the neonate.

Key organogenesis steps take place during fetal life and many functional features of the immune system are already coded in the genetic asset of the individual. However, at birth the immune system remains fairly immature. An epigenetic, postnatal instruction seems to be extremely important for the maturation of the immune system allowing its full functionality.

The cross-talk between the mother and her baby is, indeed, crucial for the optimal development of the foetus and subsequently for the full and functional maturation of the neonate.

The newborn relies for his protection almost exclusively on his innate immune system that is initially instructed and educated early in life by factors derived from his mother as well as post-natal environmental factors such as early life colonization with micro-organisms that activates the innate immunity and enhance Th1-cell polarization thereby potentially reducing atopic dermatitis with respect to the hygiene hypothesis.

A large part of this immune education is provided by factors transmitted from the mother pre-natally through the placenta or post-natally via the breast milk. Breast milk contains a number of nutrients and bioactive components, including immune cells, maternal antibodies (mainly secretory IgA), cytokines, growth factors, lactoferrin, nucleotides, triacylglycerols, fatty acids, oligosaccharides, and vitamins. All together, these components beneficially impact the health status of the newborn, conferring, among other functions, immune education and early protection.

A typical example of such transfer of immune competence is the TGF-β that could be transmitted in active from either through the placenta or absorbed by the neonates through the milk. This TGF-β is an important IgA switch factor and this is likely to be responsible, in part, for the capacity of breast-fed infant to produce higher levels of mucosal SIgA compared to non-breast fed infants. Moreover, milk soluble CD14 transmitted to the newborn contributes to prime the neonatal gut to modulate the microbial recognition and establishment of endogenous microbiota.

Diarrhea episodes are major manifestation of common infant infections of viral or bacterial aetiology and are a key health concern in paediatrics. As mentioned above there are evidences that some probiotic strains significantly improve diarrheal outcomes in infants, particularly rotavirus diarrhea. In that respect diarrhea occurrence was selected as the primary outcome in the present trial.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Diarrhea
  • Acute Respiratory Infection
  • Dietary Supplement: milk supplement 1
    milk supplement with probiotics
    Other Name: Suitable for pregnant and lactating period.
  • Dietary Supplement: milk supplement 2
    milk supplement without probiotics
    Other Name: Suitable for pregnant and lactating periode.
  • Experimental: oral supplement1
    Oral supplement for pregnant and lactating mothers
    Intervention: Dietary Supplement: milk supplement 1
  • Active Comparator: oral supplement 2
    Oral supplement for pregnant and lactating mothers
    Intervention: Dietary Supplement: milk supplement 2
  • No Intervention: Reference
    No oral supplementation during pregnancy and lactating.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
234
August 2012
April 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Expecting mothers who are in their 6th month of pregnancy
  • Willing to consume 2 x 200 ml of test product daily
  • Willing to exclusively breastfeed until the baby is at least 2-month old
  • Having signed the informed consent

Exclusion Criteria:

  • Known allergy to cow's milk
  • Subjects previously diagnosed HIV(+) and Hepatitis B (+)
  • Multiple pregnancy
  • High risk pregnancy (pre-eclampsia, diabetes, etc)
  • Currently participating or having participated in another clinical trial during the last 3 months
  • Subjects who consumed pro- and /or prebiotics-containing food/supplement* in the month before inclusion
Female
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
Philippines
 
NCT01073033
08.10 INF
No
Nestlé
Nestlé
University of the Philippines
Principal Investigator: Dr. Valerie Guinto, MD University of the Philippines
Principal Investigator: Dr. Jacinto Mantaring, MD University of the Philippines
Nestlé
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP