Maternal Probiotic Intervention to Improve Gut Health-Trial II-Pakistan

A total of 144 pregnant women in their second trimester will be enrolled. Subsequently, 96 will be randomized to receive an antibiotic for 5 days, followed by a 1-day washout period (1 week), and then either a probiotic or a placebo for 2 weeks. It will be a double-blind trial. Pregnant women will be recruited in the community through a demographic surveillance system established in Matiari, Pakistan. The study staff will approach the potential participants and will introduce them to this study. If Participants agree, a screening consent form will be administered. During this, investigators will conduct a clinical assessment and measure the participants' hemoglobin levels. Additionally, a gestational ultrasound will be performed to confirm the trimester/gestational weeks, and a stool TAC will be collected to detect the presence of enteropathogens. Based on the screening results and clinical staff assessment, women will be enrolled after giving their consent to participate in the trial. Once the participant is enrolled, investigators will collect blood, urine, LR, Vaginal Swab, and stool samples (flash frozen and CapScan) before giving them antibiotics and then either a placebo or probiotic (which will be replenished daily). Investigators will then follow them daily for compliance and adverse event data collection for both antibiotic and then either a placebo or probiotic for 21 days (3 weeks). Investigators will collect blood, urine, LR, Vaginal Swab, and stool samples (flash frozen and CapScan) after completing the intervention. The investigator will also conduct interval visits at different timepoints. Gestational ultrasounds, BIA, Skinfold, and Anthropometry will be performed at screening at 16, 20, 24, 28, 32, and 36 weeks of gestation. Pregnancy outcomes will be recorded, and then the 1-month post-birth follow-up of mother and child will be done for anthropometry and morbidity data collection.