​Experimental Medicine Platform-II



Principal Investigator: Dr. Professor Asad Ali.
Co-PI: Dr. Najeeha Iqbal, Dr. Junaid Iqbal, Dr. Zehra Jamil, Dr Sana Zahiruddin, Dr. Gulnaz Shafqat.
Funded by:​​ Bill and Melinda Gates Foundation.
Project Duration: 24 months.
Project Sites: Matiari and AKUH Karachi, Pakistan, Bangladesh, Zambia, and Burkina Faso.

Primary objectives: To assess if administration of oral vancomycin followed by VE818 to pregnant women colonised with at least 2 out of 11 selected bacterial enteropathogens results in a significant change in the mean count of these organisms between the baseline and 2 weeks after completion of the intervention (Study Day 35d +2), compared to oral vancomycin followed by placebo.

Secondary Objectives: 
  • To assess the impact of VE818 on a panel of inflammatory biomarkers in pregnant women:
    ​Plasma: CRP, AGP, sCD14, LBP, CD163, and iFABP
    Fecal: myeloperoxidase, neopterin, calprotectin and lipocalin
  • To determine if VE818 in combination with vancomycin can reduce overall enteropathogen colonization in pregnant women compared to vancomycin alone
  • To determine engraftment of the bacterial species present in VE818 in pregnant women 
  • To determine if VE818 can reduce intestinal permeability in pregnant women 
  • To determine if VE818 can impact the structure and function of fecal, vaginal and oral microbiome in pregnant women 
  • To determine if VE818 can impact the host metabolome in pregnant women.