Oral Supplement for Pregnant and Lactating Mothers
1 other identifier
interventional
234
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2010
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 17, 2010
CompletedFirst Posted
Study publicly available on registry
February 22, 2010
CompletedStudy Start
First participant enrolled
April 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedSeptember 27, 2012
September 1, 2012
2 years
February 17, 2010
September 25, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The incidence of diarrhea in infants from birth to 1 year
24 months
Secondary Outcomes (2)
In infants: growth, morbidity, immune maturation, metabolomics profile
18 months
In mothers: fetal growth, general health, immune system, metabolomics profile and preterm delivery
18 months
Study Arms (3)
oral supplement1
EXPERIMENTALOral supplement for pregnant and lactating mothers
oral supplement 2
ACTIVE COMPARATOROral supplement for pregnant and lactating mothers
Reference
NO INTERVENTIONNo oral supplementation during pregnancy and lactating.
Interventions
milk supplement with probiotics
milk supplement without probiotics
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Société des Produits Nestlé (SPN)lead
- University of the Philippinescollaborator
Study Sites (1)
Ospital Ng Muntinlupa
Manila, Philippines
Related Publications (1)
Mantaring J, Benyacoub J, Destura R, Pecquet S, Vidal K, Volger S, Guinto V. Effect of maternal supplement beverage with and without probiotics during pregnancy and lactation on maternal and infant health: a randomized controlled trial in the Philippines. BMC Pregnancy Childbirth. 2018 May 31;18(1):193. doi: 10.1186/s12884-018-1828-8.
PMID: 29855271DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dr. Valerie Guinto, MD
University of the Philippines
- PRINCIPAL INVESTIGATOR
Dr. Jacinto Mantaring, MD
University of the Philippines
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 17, 2010
First Posted
February 22, 2010
Study Start
April 1, 2010
Primary Completion
April 1, 2012
Study Completion
August 1, 2012
Last Updated
September 27, 2012
Record last verified: 2012-09