Digestive System Nutritional, Metabolic, Endocrine Pregnancy and Childbirth
Conditions
Interventions
Sponsors
Ghent University
IRSS DRO
AFRICSANTE
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Women aged 18 years or older in the first or early second trimester of pregnancy, 2. living in defined geographical areas 3. Presence of any 2 bacterial pathogens from the list of 11 selected bacterial enteropathogens (Aeromonas, Campylobacter coli, Campylobacter jejuni, Campylobacter Pan, Enteroaggregative Escherichia coli, Entero-pathogenic Escherichia coli, Enterotoxigenic Escherichia coli, Enterohaemorrhagic Escherichia coli (EHEC) Plesiomonas, Shigella_EIEC, Salmonella and Vibrio cholera ) in the fecal sample detected by TAC (qPCR).
Exclusion criteria
Exclusion criteria: Potential participants will not be enrolled if they: • have had diarrhea, defined as the passage of three or more loose fecals per 24 hours, in the preceding 2 weeks before randomization • have a fever or an active infection • have a history of chronic digestive disease • have taken antibiotics or probiotics in the preceding 2 weeks before randomization • have taken steroids or non-steroidal anti-inflammatory drugs in the preceding 2 weeks before randomization • have any illness which in the opinion of the investigator will complicate the assessment of safety or efficacy. Exclude pregnant women with 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 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 • known hypersensitivity/allergy/intolerance to any ingredient in vancomycin or the VE818 study formulation • known immunocompromised status (known history of HIV infection, autoimmune disease, diabetes mellitus, etc.,). but may be enrolled if/when these disqualifiers have expired.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is the change in the mean count of 11 targeted fecal bacterial pathogen group present between baseline and 35th day after randomization. The list of 11 selected pathogens to be detected by TAC (qPCR) includes Aeromonas, Campylobacter coli, Campylobacter jejuni, Campylobacter Pan, Enteroaggregative E. Coli, Enteropathogenic E. Coli, Enterotoxigenic E. Coli, Plesiomonas, Shigella_EIEC, Salmonella and Vibrio cholera | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in the average count and relative abundance of specific enteric pathogens (Salmonella, Shigella, Campylobacter, ETEC, EPEC, EAEC, rotavirus, norovirus, Giardia, and Cryptosporidium) detected in stool by TAC-qPCR in pregnant women at Day 21, Day 35, Day 63, and 7 days postpartum, compared to the placebo arm and the observation arm.;Persistence of VE818 strains in pregnant women, measured by shotgun metagenomic sequencing of fecal samples and CapScan collected at Day 21, Day 35, Day 63, and 7 days postpartum.;Change in the concentration of intestinal inflammation biomarkers (myeloperoxidase, neopterin, calprotectin, and lipocalin) in pregnant women measured by ELISA between the start of the study (before and after oral vancomycin treatment) and Day 21, Day 35, Day 63, and 7 days postpartum, compared to the placebo arm and the observation arm.;Change in intestinal permeability measured by the Lactulose/Rhamnose (LR) ratio in pregnant women between the start of the study (before oral vancomycin treatment) and Day 35, compared to the placebo arm and the observation arm.;Change in alpha and beta diversity of the fecal microbiota in pregnant women measured by shotgun metagenomic sequencing between the start of the study (before and after oral vancomycin treatment) and Day 21, Day 35, Day 63, and 7 days postpartum, compared to the placebo arm and the observation arm.;Change in alpha and beta diversity of the vaginal microbiome in pregnant women measured by shotgun metagenomic sequencing between the start of the study (before and after oral vancomycin treatment) and Day 21, Day 35, and Day 63, compared to the placebo arm and the observation arm.;Change in alpha and beta diversity of the oral microbiome in pregnant women measured by shotgun metagenomic sequencing between the start of the study (before oral vancomycin treatment), and Day 21 and Day 35, compared to the placebo arm and the observation arm.;Change in the blood, fecal, and urinary metabolome in pregnant wom | — |
Countries
Burkina Faso
Contacts
Public ContactMoctar OUEDRAOGO
Trial Coordinator
Outcome results
None listed