Oral Supplement for Pregnant and Lactating Mothers

Diarrhea Clinical Trial

Official title:

Oral Supplement for Pregnant and Lactating Mothers to Promote Infant Immune Maturation and Protection Against Early Life Infections

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01073033
• Other study ID #: 08.10 INF
• Status: Completed
• Phase: N/A
• First received: February 17, 2010
• Last updated: September 25, 2012
• Start date: April 2010
• Est. completion date: August 2012

Study information

• Verified date: September 2012
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Health authority: Philippines: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 234
• Est. completion date: August 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acute Respiratory Infection
• Diarrhea
• Infection
• Respiratory Tract Infections

Intervention

Dietary Supplement:
• milk supplement 1
milk supplement with probiotics
• milk supplement 2
milk supplement without probiotics

Locations

Country	Name	City	State
Philippines	Ospital Ng Muntinlupa	Manila

Sponsors (2)

Lead Sponsor	Collaborator
Nestlé	University of the Philippines

Country where clinical trial is conducted

Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of diarrhea in infants from birth to 1 year		24 months	No
Secondary	In infants: growth, morbidity, immune maturation, metabolomics profile		18 months	No
Secondary	In mothers: fetal growth, general health, immune system, metabolomics profile and preterm delivery		18 months	No