Ignite Creation Date:
2025-12-25 @ 2:41 AM
Ignite Modification Date:
2025-12-26 @ 6:27 PM
Study NCT ID:
NCT01073033
Status:
COMPLETED
Last Update Posted:
2012-09-27
First Post:
2010-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oral Supplement for Pregnant and Lactating Mothers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003967', 'term': 'Diarrhea'}, {'id': 'D001942', 'term': 'Breast Feeding'}, {'id': 'D007239', 'term': 'Infections'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020073', 'term': 'Gravidity'}], 'ancestors': [{'id': 'D055703', 'term': 'Reproductive Physiological Phenomena'}, {'id': 'D012101', 'term': 'Reproductive and Urinary Physiological Phenomena'}, {'id': 'D011247', 'term': 'Pregnancy'}, {'id': 'D012098', 'term': 'Reproduction'}, {'id': 'D017584', 'term': 'Reproductive History'}, {'id': 'D015981', 'term': 'Epidemiologic Factors'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 234}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-09-25', 'studyFirstSubmitDate': '2010-02-17', 'studyFirstSubmitQcDate': '2010-02-19', 'lastUpdatePostDateStruct': {'date': '2012-09-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence of diarrhea in infants from birth to 1 year', 'timeFrame': '24 months'}], 'secondaryOutcomes': [{'measure': 'In infants: growth, morbidity, immune maturation, metabolomics profile', 'timeFrame': '18 months'}, {'measure': 'In mothers: fetal growth, general health, immune system, metabolomics profile and preterm delivery', 'timeFrame': '18 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pregnancy', 'lactation', 'oral supplement', 'probiotics', 'early infections'], 'conditions': ['Diarrhea', 'Acute Respiratory Infection']}, 'referencesModule': {'references': [{'pmid': '29855271', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': "To assess protection against early life infections through supplementation of mothers during pregnancy to the newborns' growth, morbidity, immune status intra and extra-uterine.", 'detailedDescription': "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.\n\nIn 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.\n\nKey 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.\n\nThe 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.\n\nThe 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.\n\nA 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.\n\nA 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.\n\nDiarrhea 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."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Expecting mothers who are in their 6th month of pregnancy\n* Willing to consume 2 x 200 ml of test product daily\n* Willing to exclusively breastfeed until the baby is at least 2-month old\n* Having signed the informed consent\n\nExclusion Criteria:\n\n* Known allergy to cow's milk\n* Subjects previously diagnosed HIV(+) and Hepatitis B (+)\n* Multiple pregnancy\n* High risk pregnancy (pre-eclampsia, diabetes, etc)\n* Currently participating or having participated in another clinical trial during the last 3 months\n* Subjects who consumed pro- and /or prebiotics-containing food/supplement\\* in the month before inclusion"}, 'identificationModule': {'nctId': 'NCT01073033', 'briefTitle': 'Oral Supplement for Pregnant and Lactating Mothers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Société des Produits Nestlé (SPN)'}, 'officialTitle': 'Oral Supplement for Pregnant and Lactating Mothers to Promote Infant Immune Maturation and Protection Against Early Life Infections', 'orgStudyIdInfo': {'id': '08.10 INF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'oral supplement1', 'description': 'Oral supplement for pregnant and lactating mothers', 'interventionNames': ['Dietary Supplement: milk supplement 1']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'oral supplement 2', 'description': 'Oral supplement for pregnant and lactating mothers', 'interventionNames': ['Dietary Supplement: milk supplement 2']}, {'type': 'NO_INTERVENTION', 'label': 'Reference', 'description': 'No oral supplementation during pregnancy and lactating.'}], 'interventions': [{'name': 'milk supplement 1', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Suitable for pregnant and lactating period.'], 'description': 'milk supplement with probiotics', 'armGroupLabels': ['oral supplement1']}, {'name': 'milk supplement 2', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Suitable for pregnant and lactating periode.'], 'description': 'milk supplement without probiotics', 'armGroupLabels': ['oral supplement 2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Manila', 'country': 'Philippines', 'facility': 'Ospital Ng Muntinlupa', 'geoPoint': {'lat': 14.6042, 'lon': 120.9822}}], 'overallOfficials': [{'name': 'Dr. Valerie Guinto, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of the Philippines'}, {'name': 'Dr. Jacinto Mantaring, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of the Philippines'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Société des Produits Nestlé (SPN)', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'University of the Philippines', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}