Oral Supplement for Pregnant and Lactating Mothers

Study Description

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Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Diarrhea; Acute Respiratory Infection	Dietary Supplement: milk supplement 1; Dietary Supplement: milk supplement 2	Not Applicable

Detailed Description:

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	234 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Prevention
Official Title:	Oral Supplement for Pregnant and Lactating Mothers to Promote Infant Immune Maturation and Protection Against Early Life Infections
Study Start Date :	April 2010
Actual Primary Completion Date :	April 2012
Actual Study Completion Date :	August 2012

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: oral supplement1; Oral supplement for pregnant and lactating mothers	Dietary Supplement: milk supplement 1; milk supplement with probiotics; Other Name: Suitable for pregnant and lactating period.
Active Comparator: oral supplement 2; Oral supplement for pregnant and lactating mothers	Dietary Supplement: milk supplement 2; milk supplement without probiotics; Other Name: Suitable for pregnant and lactating periode.
No Intervention: Reference; No oral supplementation during pregnancy and lactating.

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. The incidence of diarrhea in infants from birth to 1 year [ Time Frame: 24 months ]

Secondary Outcome Measures :

1. In infants: growth, morbidity, immune maturation, metabolomics profile [ Time Frame: 18 months ]
2. In mothers: fetal growth, general health, immune system, metabolomics profile and preterm delivery [ Time Frame: 18 months ]

Eligibility Criteria

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Ages Eligible for Study:	Child, Adult, Senior
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Philippines
Ospital Ng Muntinlupa
Manila, Philippines

Sponsors and Collaborators

Nestlé

University of the Philippines

Investigators

Principal Investigator:	Dr. Valerie Guinto, MD	University of the Philippines
Principal Investigator:	Dr. Jacinto Mantaring, MD	University of the Philippines

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Nestlé
ClinicalTrials.gov Identifier:	NCT01073033 History of Changes
Other Study ID Numbers:	08.10 INF
First Posted:	February 22, 2010
Last Update Posted:	September 27, 2012
Last Verified:	September 2012

Keywords provided by Nestlé:

pregnancy; lactation; oral supplement; probiotics; early infections

Additional relevant MeSH terms:

Infection; Diarrhea; Respiratory Tract Infections	Signs and Symptoms, Digestive; Signs and Symptoms; Respiratory Tract Diseases