Fortified balanced energy–protein (BEP) supplementation is a promising intervention for improving maternal health, birth outcomes and infant growth in low- and middle-income countries. This nested biospecimen sub-study aimed to evaluate the physiological effect of multi-micronutrient-fortified BEP supplementation on pregnant and lactating women and their infants. Pregnant women (15–40 years) received either fortified BEP and iron–folic acid (IFA) (intervention) or IFA only (control) throughout pregnancy. The same women were concurrently randomized to receive either a fortified BEP supplement during the first 6 months postpartum in combination with IFA for the first 6 weeks (i.e., intervention) or the postnatal standard of care, which comprised IFA alone for 6 weeks postpartum (i.e., control). Biological specimens were collected at different timepoints. Multi-omics profiles will be characterized to assess the mediating effect of BEP supplementation on the different trial arms and its effect on maternal health, as well as birth and infant growth outcomes. The mediating effect of the exposome in the relationship between BEP supplementation and maternal health, birth outcomes and infant growth were characterized via biomonitoring markers of air pollution, mycotoxins and environmental contaminants. The results will provide holistic insight into the granular physiological effects of prenatal and postnatal BEP supplementation.

Background: Small vulnerable newborns (SVNs), including those born preterm, small for gestational age, or with low birth weight, are at higher risk of neonatal mortality and long-term health complications. Early exposure to maternal vaginal microbiota and breastfeeding plays a critical role in the development of the neonatal microbiota and immune system, especially in low-resource settings like Burkina Faso, where neonatal mortality rates remain high. Objectives: The DenBalo study aims to investigate the role of maternal and neonatal factors, such as vaginal and gut microbiota, immune development, and early nutrition, in shaping health outcomes in SVNs and healthy infants. Methods: This prospective cohort observational study will recruit 141 mother-infant pairs (70 SVNs and 71 healthy controls) from four health centers in Bobo-Dioulasso, Burkina Faso. The mother-infant pairs will be followed for six months with anthropometric measurements and biospecimen collections, including blood, breast milk, saliva, stool, vaginal swabs, and placental biopsies. Multi-omics approaches, encompassing metagenomics, metabolomics, proteomics, and immune profiling, will be used to assess vaginal and gut microbiota composition and functionality, immune cell maturation, and cytokine levels at critical developmental stages. Conclusions: This study will generate comprehensive data on how microbiota, metabolomic, and proteomic profiles, along with immune system development, differ between SVNs and healthy infants. These findings will guide targeted interventions to improve neonatal health outcomes and reduce mortality, particularly in vulnerable populations.

Background: Accurate determination of gestational age by way of ultrasound is challenging in resource-limited settings like Burkina Faso, leading to the use of alternative methods, though their accuracy and agreement remain poorly established. This practice leads to inadequate risk assessment during pregnancy and failure to identify preterm birth, potentially contributing to high neonatal mortality rates. The purpose of this study was to determine the agreement among alternative methods for gestational age estimation and the Alliance for Maternal and Newborn Health Improvement (AMANHI) method in Burkina Faso. Methods: Data were obtained from a prospective cohort study involving pregnant women in the second or third trimester in Bobo-Dioulasso to evaluate the agreement of last menstrual period (LMP), symphysis-fundal height (SFH), Dubowitz, Hadlock, and AMAHNI methods to estimate gestational age. The degree of agreement was assessed using the Bland–Altman method and intraclass correlation coefficients. The AMANHI method, validated for late pregnancy, was used as the reference standard. Results: A total of 768 pregnant women were included in the analysis. Plots showed a lack of agreement between the AMANHI method and all other methods, with 95% limits of agreement ranging from −7.6 to +9.8 weeks. Additionally, the incidence of preterm birth was consistently higher when assessed using the alternative methods compared with the AMANHI method. Conclusions: The clinical methods (SFH, LMP, Dubowitz) disagree with the ultrasound methods (AMANHI, Hadlock), but the ultrasound methods produce more similar results. The routine application of other methods is likely to result in an overestimation of preterm birth incidence compared with AMANHI. These findings highlight the urgent need to improve access to obstetric ultrasound and to provide comprehensive training in the application of the AMANHI method for accurate late-term gestational age estimation in Burkina Faso.

Biological pathways, including individual gut microbiome are potential barriers for maternal nutritional supplementation to improvement in infant growth. We evaluated the impact of balanced energy-protein (BEP) supplementation during pregnancy and the first six months of lactation on the composition and functionality of gut microbiome in mothers and their infants in rural Burkina Faso. Our findings reveal that BEP supplementation led to a significant increase in microbiome diversity during pregnancy. In the second trimester, there was a notable decrease in the abundance of an Oscillospiraceae species, while postpartum, the abundance of Bacteroides fragilis increased. We identified concerted enriched or depleted microbial pathways associated with BEP supplementation, including the phosphotransferase system, a critical mechanism for bacterial carbohydrates uptake, which exhibited enrichment in infants born to BEP-supplemented mothers. Despite these observations, the intricate biological connections with other omics necessitate further analysis to fully elucidate the underlying comprehensive biological pathways.