Ability of VE818 to Reduce Enteropathogen Colonization and Improve Environmental Enteropathy in Pregnant Women: a Proof of Concept and Phase II Randomized Placebo-controlled Trial in Bangladesh, Pakistan, Zambia and Burkina Faso

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

Objectives: The primary objective is 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.

Methods: Pregnant women will be recruited from the community of Matiari in Pakistan. The study population will be women aged 18 years or older in the first trimester or early second trimester of pregnancy. Study procedures will be explained in detail, and written consent will be taken before enrollment. Those women who give consent to participation will undergo a screening process, which will check if any exclusion criteria are fulfilled. After consent and screening, they will be randomised into one of the three arms: intervention arm (oral vancomycin followed by VE818), placebo-control arm (oral vancomycin followed by placebo), or observation-only arm. The allocation sequence will be generated by the trial statistician using a code with block permutation. The participant will remain free to withdraw at any time from the trial without giving reasons and without prejudicing her further treatment. Biological samples, including blood, saliva, urine, stool, vaginal swab, and intestinal luminal contents through CapScan. CapScan is a non-invasive device (capsule) that collects gastrointestinal samples along the gastrointestinal tract following ingestion and passes into the stool. Outcome measures/variables: The primary endpoint is the change in the mean count in the number of 11 selected fecal bacterial pathogen groups present between baseline and 2 weeks after completion of the 14-day course with Placebo or VE818 (Study arms 2 and 3), which corresponds to the 35th day, +2 from the first dose of oral vancomycin. The 11 enteropathogen targets will be detected by customized real-time quantitative PCR-based TaqMan Array Cards (TAC-qPCR) and include the following organisms: Aeromonas, Campylobacter coli, Campylobacter jejuni, Campylobacter Pan, Enteroaggregative Escherichia coli (E. coli), Enteropathogenic E. coli, Enterotoxigenic E. coli, Plesiomonas, Shigella\_Enteroinvasive E. coli (EIEC), Salmonella, and Klebsiella pneumoniae

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 49
Healthy Volunteers: f
View:

• Women aged 18 years or older in their first or early second trimester of pregnancy (13-17 weeks of gestational age \[GA\]), living in defined geographical areas of Bangladesh (Matlab), Pakistan, Zambia, and Burkina Faso, where it can be assumed that environmental enteropathy is prevalent

• Presence of any 2 out of 11 selected bacterial pathogen targets (Aeromonas, Campylobacter coli, Campylobacter jejuni, Campylobacter Pan, Enteroaggregative Escherichia coli, Enteropathogenic Escherichia coli, Enterotoxigenic Escherichia coli, Plesiomonas, Shigella\_EIEC, Salmonella and Klebsiella pneumoniae in fecal samples measured by TAC-qPCR.

• Presence of any of the following WASH conditions -

‣ use surface water, unimproved water, or limited water for drinking; OR

⁃ use surface water, unimproved water, or limited water for cooking; OR

⁃ use surface water, unimproved water, or limited water for washing utensils; OR

⁃ practice open defecation, use unimproved sanitation (toilet facility), or limited sanitation (toilet facility); OR

⁃ lack facility or have limited facility for handwashing

Locations
Other Locations
Pakistan
Mother and Child Health Research and Training Center, AKU
RECRUITING
Matiari
Contact Information
Primary
Asad Ali Syed, MPH
asad.ali@aku.edu
+92 2134864233
Backup
Sheraz Ahmed, Masters
sheraz.ahmed@aku.edu
+92222760394
Time Frame
Start Date: 2025-08-30
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 144
Treatments
Active_comparator: Oral vancomycin + VE818
Drug: VE818 VE818 is an 11-strain bacterial consortium rationally designed by Vedanta Biosciences Inc., to displace enteropathogens and reduce intestinal inflammation in pregnant women~Drug: Oral Vancomycin Oral vancomycin in capsule form will be administered three times daily for 5 days at 250mg per dose. Because oral vancomycin is a non-absorbable antibiotic, the likelihood of systemic absorption is minimal and therefore, it is not associated with the adverse events attributable to the intravenous formulation
Placebo_comparator: Oral vancomycin + Placebo
Drug: Placebo Enteric Capsules filled with approximately 400mg of Microcrystalline Cellulose (bulking agent)~Drug: Oral Vancomycin Oral vancomycin in capsule form will be administered three times daily for 5 days at 250mg per dose. Because oral vancomycin is a non-absorbable antibiotic, the likelihood of systemic absorption is minimal and therefore, it is not associated with the adverse events attributable to the intravenous formulation
No_intervention: Observation only arm
The observational arm is a no-intervention control group within a Phase II randomized controlled trial that enrolls pregnant women colonized with at least 2 out of 11 selected bacterial enteropathogens recruited from community. This arm includes 48 participants per site (192 total across 4 sites) randomized in a 1:1:1 ratio alongside two intervention arms (oral vancomycin + placebo and oral vancomycin + VE818), with participants followed at comparable timepoints including baseline assessments, multiple visits during pregnancy, delivery, and up to 1 month postpartum for comprehensive evaluation of mother-infant dyads without receiving any study intervention.
Sponsors
Collaborators: Bill and Melinda Gates Foundation, International Centre for Diarrhoeal Disease Research, Bangladesh, Institut Pasteur de Dakar, University of Zambia
Leads: Aga Khan University

This content was sourced from clinicaltrials.gov

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