Nutritional, Metabolic, Endocrine Pregnancy and Childbirth Paediatrics
Conditions
Interventions
No treatment
Vancomycin plus placebo
Vancomycin plus VE818
Sponsors
TROPGAN
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Women aged 18 years or older in the first or early second trimester of pregnancy, living in defined ge-ographical areas of Chawama, Misi and Kuku compounds where, based on previous studies, it can be assumed that environmental enteropathy is prevalent. EMP Pregnancy 2 Trial Protocol Version 0.1, 30th October 2023 Page 22 of 50 Presence of any 2 bacterial pathogens from the list of selected bacterial enteropathogens (non-ty-phoid salmonellae, Shigella spp/enteroinvasive EIEC, Campylobacter spp, ETEC, EPEC, EAEC, EHEC, Aer-omonas spp, Plesiomonas spp, Vibrio cholerae,) in the stool sample detected by TAC (qPCR).
Exclusion criteria
Exclusion criteria: Potential participants will not be enrolled if they: • have had diarrhoea, defined as the passage of three or more loose stools per 24 hours, in the preceding 14 days • have taken antibiotics or probiotics in the preceding 14 days • have taken steroids or non-steroidal anti-inflammatory drugs in the preceding 14 days ? have any illness which in the opinion of the investigator will complicate the assessment of safety or efficacy ? have severe anemia as determined using finger stick hemoglobin and Hgb < 8 g/dl.(Ref: WHO/UNICEF/UNU, “Iron Deficiency Anaemia Assessment, Prevention, and Control: A Guide for Programme Managers,” Geneva, 2001) • have any gastrointestinal contraindication to ingestion of a capsule (known or suspected gastrointestinal obstruction, stricture, fistula, gastroparesis, or any swallowing disorder.) • have any contra-indication to the use of vancomycin • have a plan to observe fast any time during the intervention period • have a plan to leave the study area within the follow-up period • inclusion in any other interventional trial but may be enrolled if/when these disqualifiers have expired.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the change in the mean count of nine selected fecal bacterial pathogens present between baseline and day 35 (acceptable window day 35-37) after randomization, which will be 15 days after the last dose of intervention (for those in arms 1 and 2). The selected pathogens to be detected by TAC (qPCR) include non-typhoid salmonellae, Shigella spp/enteroinvasive EIEC, Campylobacter spp, Enterotoxigenic Escherichia coli (ETEC), Enteropathogenic Escherichia coli (EPEC), Enteroaggregative Escherichia coli (EAEC), Enterohaemorrhagic Escherichia coli (EHEC), Aeromonas spp, Plesiomonas spp, Vibrio cholerae, rotavirus, norovirus, Giardia intestinalis, and Cryptosporidium spp. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Change in average count and relative abundance of specific enteropathogens (non-typhoid salmo-nellae, Shigella spp/enteroinvasive EIEC, Campylobacter spp, ETEC, EPEC, EAEC, EHEC, Aeromonas spp, Plesiomonas spp, Vibrio cholerae, rotavirus, norovirus, Giardia intestinalis and Cryptosporidium spp) in pregnant women detected in stool by TAC (qPCR) between baseline (before and after oral vancomycin treatment) and the last dose of 14-day VE-818 intervention (21st day, +2), 14 days after the last dose of 14-day VE-818 intervention (35th day, +2), 42 days after the last dose of 14-day VE-818 intervention (63rd day, +2), and 7 day post-partum in Treatment arm, compared to Placebo arm and Observation-only arm • Engraftment of VE-818 organisms in pregnant women measured through stool samples collected at 14 days after the last dose of 14-day VE-818 intervention (35th day, +2), 42 days after the last dose of 14-day VE-818 intervention (63rd day, +2) and 7 days after birth • Change in a panel of fecal biomarkers (myeloperoxidase, neopterin, calprotectin and lipocalin) in pregnant women between baseline (before and after oral vancomycin treatment) and 14 days after the last dose of 14-day VE-818 intervention (21st day, +2), 14 days after the last dose of 14-day in-tervention (35th day, +2), 42 days after the last dose of 14-day intervention (63rd day, +2), and 7 day post-partum in Treatment arm, compared to Placebo arm and Observation-only arm • Change in a panel of plasma biomarkers (CRP, AGP, sCD14, LBP, CD163 and iFABP) in pregnant women between baseline (before and after oral vancomycin treatment) and 14 days after the last dose of 14-day intervention (35th day, +2), 42 days after the last dose of 14-day intervention (63rd day, +2), and 7 day post-partum in Treatment arm, compared to Placebo arm and Observation-only arm • Change in LR ratio in pregnant women between baseline (before oral vancomycin treatment) and 14 days after the last dose of 14-day VE-818 intervention | — |
Countries
Zambia
Contacts
Public ContactMilika Sakala
Trial Coordinators or Managers
Outcome results
None listed