Effects of Maternal Fortified Balanced Energy-Protein Supplementation on the Mother-Infant Gut Microbiome: A Sub-Study of the MISAME-III Randomized Controlled Trial

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. ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Trial NCT03533712 ### Clinical Protocols ### Funding Statement The work is supported by the Bill & Melinda Gates Foundation (OPP1175213). Lishi Deng is supported by the China Scholarship Council (Grant No. 202207650056). Steff Taelman is supported by the Flemish Agency for Innovation and Entrepreneurship (VLAIO HBC.2020.2292). This publication includes data generated at the UC San Diego IGM Genomics Center utilizing an Illumina NovaSeq 6000 that was purchased with funding from a National Institutes of Health SIG grant (#S10 OD026929). ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The Commissie voor Medische Ethiek (CME) of Ghent University Hospital (protocol code: B670201734334 and date of 10/08/2020) and the Comité dÉthique Institutionnel de la Recherche En Sciences de la Santé (CEIRES) of the Institut de Recherche en Sciences de la Santé (IRSS) (protocol code 50-2020/CEIRES and date of 22/10/2020) approval for this work. Informed consent was obtained from all subjects involved in the study. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes Given the personal nature of the data, data will be made available through a data-sharing agreement. Please contact carl.lachat@ugent.be for any queries. Supporting study documents, including the study protocol and questionnaires, are publicly available on the studys website: https://misame3.ugent.be (accessed on 23 November 2023).