Environmental Enteric Dysfunction (EED)Phase 2MPIGH-IINCT07207434
Maternal Probiotic Intervention to Improve Gut Health-Trial II-Pakistan
A Phase 2 study testing Oral Vancomycin and VE818 in people with Environmental Enteric Dysfunction (EED) and Stunting, run by Aga Khan University at 1 site in Pakistan.
Trial summary
Burden: Environmental Enteric Dysfunction (EED) is an enteropathic condition characterised by altered gut permeability, infiltration of immune cells, and changes in villous architecture and cell differentiation. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Environmental Enteric Dysfunction (EED), Stunting
- What is being tested?
- Oral Vancomycin and VE818
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 1 sitePakistan
- Study dates
- 30 Aug 2025to Jun 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Potential participants will not be enrolled if they:
- have MUAC ≥30 cm
- are carrying more than one fetus (i.e., multiple pregnancy)
- have diarrhea, defined as the passage of three or more loose stools per 24 hours, or have had diarrhea in the preceding 14 days
- have fever or an active infection
- have taken antibiotics or probiotics in the preceding 14 days
Show all 19Show fewer
- have taken steroids or non-steroidal anti-inflammatory drugs in the preceding 14 days
- have severe anemia as determined using finger stick Hb < 8 g/dl
- have a history of chronic digestive disease
- have any gastrointestinal contraindication to ingestion of a capsule (known or suspected gastrointestinal obstruction, stricture, fistula, gastroparesis, or any swallowing disorder)
- have known immunocompromised status (known history of HIV infection, autoimmune disease, diabetes mellitus, etc.)
- have known drug hypersensitivity/allergy/intolerance
- have chronic disease or any other illness or condition which in the opinion of the investigator will complicate the assessment of safety or efficacy
- are medically disqualified: Any potential participant who is deemed medically unfit for trial enrollment by a non-study healthcare provider, due to the presence of severe or unstable health conditions that could compromise safety or interfere with the study outcomes, will be excluded from participation
- 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
- are participating in any other interventional trial
- belong to a household from which another woman is already enrolled in the study
- but may be enrolled if/when these disqualifiers have expired.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Mother and Child Health Research and Training Center, AKU
Matiari, Sindh, 71000
About this study
Official title: 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
Burden: Environmental Enteric Dysfunction (EED) is an enteropathic condition characterised by altered gut permeability, infiltration of immune cells, and changes in villous architecture and cell differentiation. EED is a major reason of malnourishment, poor neurological development, stunting, oral vaccine failure, and infection. It is believed that EED is responsible for 40% of all childhood stunting.
Relevance: This trial aims to investigate the concept that a probiotic or live biotherapeutic product, capable of improving gut microbiota composition, can also displace enteropathogens and reduce biomarkers of intestinal inflammation, thereby promoting gut health. This will restore healthy microbial signalling to the host epithelium, ameliorate barrier function through secretion of mucus and antimicrobial factors, and improve nutrient availability.
Read more
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
Read the detailed description
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.
- Conditions
- Environmental Enteric Dysfunction (EED), Stunting
- Being tested
- Oral Vancomycin, VE818, Placebo
- Keywords
- probiotic, microbiome, pregnant women, capscan device, urine LR, VE818, Pakistan, malnourished children, biomarkers, EED
- Medical subject headings
- Growth Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral VancomycinDrug
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
VE818Drug
VE818 is an 11-strain bacterial consortium rationally designed by Vedanta Biosciences Inc., to displace enteropathogens and reduce intestinal inflammation in pregnant women.
PlaceboDrug
Enteric capsules filled with approximately 400mg of microcrystalline cellulose (bulking agent)
| Study group | Role | What they receive |
|---|---|---|
| Oral vancomycin + VE818 | Active comparator | 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 Receives: Drug: Oral Vancomycin; Drug: VE818 |
| Oral vancomycin + Placebo | Placebo comparator | 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 Receives: Drug: Oral Vancomycin; Drug: Placebo |
| Observation only arm | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Mean Count of 11 Selected Fecal Bacterial Pathogen Groups as Measured by TAC-qPCR between enrollment and 2 weeks after completion of the 14-day course with Placebo or VE818
The primary endpoint is the change in the mean count in the number of 11 selected fecal bacterial pathogen groups present between enrollment and 2 weeks after completion of the 14-day course with Placebo or VE818 (Study arms 2 and 3), which corresponds to 35th day, +2 from the first dose of oral vancomycin.
Measured: Between enrollment and 2 weeks after completion of the 14-day course with Placebo or VE818
Secondary outcomes (9)
Change in prevalence of specific enteropathogens not included in the primary endpoint in pregnant women as Measured by TAC-qPCR
Change in prevalence of specific enteropathogens (i.e., rotavirus, norovirus, Giardia, Cryptosporidium, and bacterial pathogens not included in the primary endpoint) in pregnant women detected in feces by TAC-qPCR between baseline (Day 0), end of oral vancomycin treatment (Day 6) the last dose of the 14-day VE818 intervention (21st day, +2), 14 days after the last dose of VE818 (35th day, +2), 42 days after the last dose of VE818 (63rd day, +2), and 7 day post-partum in the Treatment arm compared to Placebo arm and Observation-only arm.
Measured: Enrollment, Day 6 (18 weeks gestation), Day 21, Day 35 (23 weeks gestation), Day 63 (28 weeks gestation), and 7 days post-partum.
Engraftment of VE818 strains in pregnant women as Measured by Shotgun Metagenomic Sequencing
Engraftment of VE818 strains in pregnant women as measured by shotgun metagenomic sequencing of fecal samples collected at the end of the 14-day VE818 intervention (21st day, +2), 14 days after the last dose of VE818 (35th day, +2), 42 days after the last dose of VE818 (63rd day, +2) and 7 days post-partum
Measured: At Day 21, Day 35 (23 weeks gestation), Day 63 (28 weeks gestation), and 7 days post-partum.
Change from Enrollment in the Concentration of a Panel of Plasma Biomarkers as Measured by ELISA
Change in a panel of plasma biomarkers (CRP, AGP, sCD14, LBP, CD163 and iFABP) in pregnant women as measured by ELISA between baseline (Day 0), end of oral vancomycin treatment (Day 6), 14 days after the last dose the of 14-day intervention (35th day, +2) and, 42 days after the last dose of VE818 (63rd day, +2) in the Treatment arm compared to Placebo arm and Observation-only arm.
Measured: At Enrollment, Day 6 (18 weeks gestation), Day 35 (23 weeks gestation), and Day 63 (28 weeks gestation).
Change from Enrollment in the Concentration of a Panel of Fecal Biomarkers as Measured by ELISA
Change in a panel of fecal biomarkers (myeloperoxidase, neopterin, calprotectin and lipocalin) in pregnant women as measured by ELISA between baseline (Day 0) , end of oral vancomycin treatment (Day 6), the last dose of the 14-day VE818 intervention (21st day, +2), 14 days after the last dose of VE818 (35th day, +2) 42 days after the last dose VE818 (63rd day, +2), and 7 day post-partum in the Treatment arm, compared to Placebo arm and Observation-only arm.
Measured: At Enrollment, Day 6 (18 weeks gestation), Day 21, Day 35 (23 weeks gestation), Day 63 (28 weeks gestation), and 7 days post-partum
Change from Enrollment in Intestinal Permeability as Measured by Lactulose/Rhamnose (LR) Ratio
Change in intestinal permeability as measured by Lactulose/Rhamnose (LR) ratio in pregnant women between baseline and 14 days after the last dose of 14-day VE818 intervention (35th day, +2) in the Treatment arm, compared to Placebo arm and Observation-only arm.
Measured: At Enrollment and Day 35 (23 weeks gestation).
Change from Enrollment in Alpha and Beta Diversity of Fecal Microbiome as Measured by Shotgun Metagenomics Sequencing
Change in alpha and beta diversity of fecal microbiome in pregnant women as measured by shotgun metagenomics sequencing between baseline (Day 0), end of oral vancomycin treatment (Day 6), the last dose of the 14-day VE818 intervention (21st day, +2), 14 days after the last dose of VE818 (35th day, +2 day), 42 days after the last dose of VE818 (63rd day, +2), and 7 day post-partum in the Treatment arm, compared to Placebo arm and Observation-only arm
Measured: At Enrollment, Day 6 (18 weeks gestation), Day 21, Day 35 (23 weeks gestation), Day 63 (28 weeks gestation), and 7 days post-partum.
Change from Enrollment in Alpha and Beta Diversity of Vaginal Microbiome as Measured by Shotgun Metagenomics Sequencing
Change in alpha and beta diversity of vaginal microbiome in pregnant women as measured by shotgun metagenomics sequencing between baseline, end of oral vancomycin treatment (Day 6), 14 days after the last dose of the 14-day VE818 intervention (35th day, +2), and 42 days after the last dose of VE818 (63rd day, +2), in the Treatment arm, compared to Placebo arm and Observation-only arm
Measured: At Enrollment, Day 6 (18 weeks gestation), Day 35 (23 weeks gestation), and Day 63 (28 weeks gestation).
Change from Enrollment in Alpha and Beta Diversity of Oral Microbiome as Measured by Shotgun Metagenomics Sequencing
Change in alpha and beta diversity of oral microbiome in pregnant women as measured by shotgun metagenomics sequencing between baseline (Day 0) (and 14 days after the last dose of the 14-day VE818 intervention (35th day, +2), in the Treatment arm, compared to Placebo arm and Observation-only arm
Measured: At Enrollment and Day 35 (23 weeks gestation).
Change from Enrollment in the Metabolomic Profile of Plasma and Stool Samples
Change in metabolome (plasma, and stool) in pregnant women between baseline (Day 0), end of oral vancomycin treatment (Day 6), the last dose of the 14-day VE818 intervention (21st day +2; stool only), 14 days after the last dose of VE818 (35th day+2) 42 days after the last dose of VE818 (63rd day +2) and 7 days post birth (stool only) in the Treatment arm, compared to Placebo arm and Observation-only arm
Measured: At Enrollment, Day 6 (18 weeks gestation), Day 21 (stool only), Day 35 (23 weeks gestation), Day 63 (28 weeks gestation), and 7 days post-partum (stool only).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2025
- Study start30 Aug 2025
- Primary completion31 Dec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Environmental Enteric Dysfunction (EED)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, International Centre for Diarrhoeal Disease Research, Bangladesh, University of Zambia, Institut Pasteur de Dakar
- Responsible party
- Principal investigator, Dr Syed Asad Ali, Aga Khan University
- Investigators
- Asad Ali Syed, MPH, Principal investigator, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07207434
- Sponsor's protocol ID
- 2024-9410-27780
- Acronym
- MPIGH-II
- Status last verified
- Oct 2026
- First submitted
- 16 Aug 2025
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual data for all primary and secondary outcome measures will be made available.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07207434
- Acronym / sponsor ID
- MPIGH-II / 2024-9410-27780
- Conditions
- Environmental Enteric Dysfunction (EED), Stunting
- Keywords
- probiotic, microbiome, pregnant women, capscan device, urine LR, VE818, Pakistan, malnourished children
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, International Centre for Diarrhoeal Disease Research, Bangladesh, University of Zambia, Institut Pasteur de Dakar
- Study start
- 30 Aug 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 6 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Burden: Environmental Enteric Dysfunction (EED) is an enteropathic condition characterised by altered gut permeability, infiltration of immune cells, and changes in villous architecture and cell differentiation. EED is a major reason of malnourishment, poor neurological development, stunting, oral vaccine failure, and infection. It is believed that EED is responsible for 40% of all childhood stunting.
Relevance: This trial aims to investigate the concept that a probiotic or live biotherapeutic product, capable of improving gut microbiota composition, can also displace enteropathogens and reduce biomarkers of intestinal inflammation, thereby promoting gut health. This will restore healthy microbial signalling to the host epithelium, ameliorate barrier function through secretion of mucus and antimicrobial factors, and improve nutrient availability.
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
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Oral vancomycin + VE818 | Active comparator | Drug: Oral Vancomycin, Drug: VE818Drug: 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 |
| Oral vancomycin + Placebo | Placebo comparator | Drug: Oral Vancomycin, Drug: PlaceboDrug: 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 |
| Observation only arm | No intervention | –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. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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 -
Key exclusion criteria (19 listed)
- have MUAC ≥30 cm
- are carrying more than one fetus (i.e., multiple pregnancy)
- have diarrhea, defined as the passage of three or more loose stools per 24 hours, or have had diarrhea in the preceding 14 days
- have fever or an active infection
- have taken antibiotics or probiotics in the preceding 14 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral VancomycinOral 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 | Drug | Oral vancomycin + Placebo, Oral vancomycin + VE818 |
| VE818VE818 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 + VE818 |
| PlaceboEnteric capsules filled with approximately 400mg of microcrystalline cellulose (bulking agent) | Drug | Oral vancomycin + Placebo |
Primary outcome
Change in the Mean Count of 11 Selected Fecal Bacterial Pathogen Groups as Measured by TAC-qPCR between enrollment and 2 weeks after completion of the 14-day course with Placebo or VE818
Time frame: Between enrollment and 2 weeks after completion of the 14-day course with Placebo or VE818
The primary endpoint is the change in the mean count in the number of 11 selected fecal bacterial pathogen groups present between enrollment and 2 weeks after completion of the 14-day course with Placebo or VE818 (Study arms 2 and 3), which corresponds to 35th day, +2 from the first dose of oral vancomycin.
9 secondary outcomes
Change in prevalence of specific enteropathogens not included in the primary endpoint in pregnant women as Measured by TAC-qPCR
Time frame: Enrollment, Day 6 (18 weeks gestation), Day 21, Day 35 (23 weeks gestation), Day 63 (28 weeks gestation), and 7 days post-partum.
Engraftment of VE818 strains in pregnant women as Measured by Shotgun Metagenomic Sequencing
Time frame: At Day 21, Day 35 (23 weeks gestation), Day 63 (28 weeks gestation), and 7 days post-partum.
Change from Enrollment in the Concentration of a Panel of Plasma Biomarkers as Measured by ELISA
Time frame: At Enrollment, Day 6 (18 weeks gestation), Day 35 (23 weeks gestation), and Day 63 (28 weeks gestation).
Change from Enrollment in the Concentration of a Panel of Fecal Biomarkers as Measured by ELISA
Time frame: At Enrollment, Day 6 (18 weeks gestation), Day 21, Day 35 (23 weeks gestation), Day 63 (28 weeks gestation), and 7 days post-partum
Change from Enrollment in Intestinal Permeability as Measured by Lactulose/Rhamnose (LR) Ratio
Time frame: At Enrollment and Day 35 (23 weeks gestation).
Change from Enrollment in Alpha and Beta Diversity of Fecal Microbiome as Measured by Shotgun Metagenomics Sequencing
Time frame: At Enrollment, Day 6 (18 weeks gestation), Day 21, Day 35 (23 weeks gestation), Day 63 (28 weeks gestation), and 7 days post-partum.
Change from Enrollment in Alpha and Beta Diversity of Vaginal Microbiome as Measured by Shotgun Metagenomics Sequencing
Time frame: At Enrollment, Day 6 (18 weeks gestation), Day 35 (23 weeks gestation), and Day 63 (28 weeks gestation).
Change from Enrollment in Alpha and Beta Diversity of Oral Microbiome as Measured by Shotgun Metagenomics Sequencing
Time frame: At Enrollment and Day 35 (23 weeks gestation).
Change from Enrollment in the Metabolomic Profile of Plasma and Stool Samples
Time frame: At Enrollment, Day 6 (18 weeks gestation), Day 21 (stool only), Day 35 (23 weeks gestation), Day 63 (28 weeks gestation), and 7 days post-partum (stool only).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: Yes. De-identified individual data for all primary and secondary outcome measures will be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Asad Ali Syed, MPH principal investigator
Aga Khan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oral Vancomycin and VE818 in people with Environmental Enteric Dysfunction (EED) and Stunting, run by Aga Khan University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Mean Count of 11 Selected Fecal Bacterial Pathogen Groups as Measured by TAC-qPCR between enrollment and 2 weeks after completion of the 14-day course with Placebo or VE818 (time frame: Between enrollment and 2 weeks after completion of the 14-day course with Placebo or VE818). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026; AzTrials last refreshed its copy on 8 Nov 2026.