Environmental Enteric DysfunctionPhase 2MPIGH-IINCT06817031
Maternal Probiotic Intervention to Improve Gut Health - Trial II - Bangladesh
A Phase 2 study testing VE818 and Oral Vancomycin in people with Environmental Enteric Dysfunction, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 1 site in Bangladesh.
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 years and older, women only
- Conditions the study is for
- Environmental Enteric Dysfunction
- What is being tested?
- VE818 and Oral Vancomycin
- 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 siteBangladesh
- Study dates
- 20 Apr 2025to Oct 2026
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older 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
- AND
- 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.
- AND
- Presence of any of the following WASH conditions -
- use surface water, unimproved water, or limited water for drinking; OR
Show all 10Show fewer
- 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. Contact the study team or a site near you to ask about taking part.
Bangladesh1 site
International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b)
Chāndpur
About this study
Official title: Ability of the Probiotic 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.
Knowledge gap: To date the focus of research on childhood stunting has been on the young child. It is increasingly appreciated, however, that stunting often begins in utero and the focus has shifted to women's health and pregnancy. Results from rural Bangladesh reveal poor gestational weight gain that ultimately leads to intrauterine growth restriction, low birth weight and ultimately stunting and wasting. Another study recently completed in slum settlements of Dhaka, Bangladesh demonstrated a high prevalence of EED among undernourished women. Intestinal histopathology was abnormal in more than 80% of women. We postulate that growth retardation in utero is a consequence of EED in the mother during pregnancy and lactation. This leads to systemic inflammation, which lead to disadvantageous partitioning of nutrients, and reduced nutrient availability.
Read more
Relevance: This trial will explore the conceptual framework that a probiotic or live biotherapeutic product that can improve the composition of gut microbiota, can also displace enteropathogens and reduce biomarkers of intestinal inflammation to promote 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 in antenatal clinics and in the community in Matlab in Bangladesh, Matiari in Pakistan, Lusaka in Zambia and, and Bobo-Dioulasso in Burkina Faso. 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 either 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 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 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
Across the site pregnant women will be screened for eligibility in their first or early second trimester of pregnancy (13-17 weeks of GA) and will be enrolled and randomized into three arms (48 women per arm). Participants will be dosed depending on the randomized arm.
As per WHO recommendation, participants in all 3 arms will receive Multiple Micronutrient Supplements (MMS) as part of routine antenatal care, which they will begin taking at enrollment and continue throughout pregnancy.
Blinding will be implemented for the comparison between the Treatment arm and the Placebo arm. However, it is not feasible to apply blinding to the Observation-only arm as the participants in this group will receive no intervention and the arm solely serves as an observational arm.
After the end of the intervention, pregnant women will be followed up until birth to record birth and pregnancy outcomes. Mother-infant dyads will be sampled 7 days after birth. Maternal and Infant health outcomes will be followed up to 1 month after childbirth to record clinical outcomes during this period.
- Conditions
- Environmental Enteric Dysfunction
- Being tested
- VE818, Placebo, Oral Vancomycin
- Keywords
- probiotic, environmental enteropathy, pregnancy, maternal, gut health, microbiome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
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
| Study group | Role | What they receive |
|---|---|---|
| Observation only arm | No intervention | Not described |
| oral vancomycin + placebo | Placebo comparator | Not described Receives: Drug: Placebo; Drug: Oral Vancomycin |
| oral vancomycin + VE818 | Active comparator | Not described Receives: Drug: VE818; Drug: Oral Vancomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the mean count in the number of 11 selected fecal bacterial pathogen groups present between baseline and endline
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 35th day, +2 from the first dose of oral vancomycin.
Measured: Between baseline 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
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 (comparable timepoints)
Measured: Baseline, day 6, day 21, day 35, day 63 and 7 day post-partum
Engraftment of VE818 strains in pregnant women
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: day 21, day 35, day 63 and 7 day post-partum
Change in a panel of plasma biomarkers in pregnant women 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 (comparable timepoints)
Measured: Baseline, day 6, day 35, and day 63
Change in a panel of fecal biomarkers in pregnant women 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 (comparable timepoints)
Measured: Baseline, day 6, day 21, day 35, day 63 and 7 day post-partum
Change in intestinal permeability as measured by Lactulose/Rhamnose (LR) ratio in pregnant women
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 (comparable timepoints)
Measured: Baseline and day 35
Change in alpha and beta diversity of fecal microbiome in pregnant women
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 ( comparable timepoints)
Measured: Baseline, day 6, day 21, day 35, day 63 and 7 day post-partum
Change in alpha and beta diversity of vaginal microbiome in pregnant women
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 (comparable timepoints)
Measured: Baseline, day 6, day 35, and day 63
Change in alpha and beta diversity of oral microbiome in pregnant women
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 (comparable timepoints)
Measured: Baseline and day 35
Change in metabolome (plasma and stool) in pregnant women
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 (comparable timepoints)
Measured: Baseline, day 6, day 21, day 35, day 63 and 7 day post-partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start20 Apr 2025
- Primary completionApr 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Environmental Enteric DysfunctionStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06817031
- Sponsor's protocol ID
- PR-24002
- Acronym
- MPIGH-II
- Status last verified
- Dec 2025
- First submitted
- 4 Feb 2025
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ability of the Probiotic 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
- NCT06817031
- Acronym / sponsor ID
- MPIGH-II / PR-24002
- Conditions
- Environmental Enteric Dysfunction
- Keywords
- probiotic, environmental enteropathy, pregnancy, maternal, gut health, microbiome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, BangladeshUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Study start
- 20 Apr 2025 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 10 Feb 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.
Knowledge gap: To date the focus of research on childhood stunting has been on the young child. It is increasingly appreciated, however, that stunting often begins in utero and the focus has shifted to women's health and pregnancy. Results from rural Bangladesh reveal poor gestational weight gain that ultimately leads to intrauterine growth restriction, low birth weight and ultimately stunting and wasting. Another study recently completed in slum settlements of Dhaka, Bangladesh demonstrated a high prevalence of EED among undernourished women. Intestinal histopathology was abnormal in more than 80% of women. We postulate that growth retardation in utero is a consequence of EED in the mother during pregnancy and lactation. This leads to systemic inflammation, which lead to disadvantageous partitioning of nutrients, and reduced nutrient availability.
Relevance: This trial will explore the conceptual framework that a probiotic or live biotherapeutic product that can improve the composition of gut microbiota, can also displace enteropathogens and reduce biomarkers of intestinal inflammation to promote 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 in antenatal clinics and in the community in Matlab in Bangladesh, Matiari in Pakistan, Lusaka in Zambia and, and Bobo-Dioulasso in Burkina Faso. 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 either 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 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 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
Across the site pregnant women will be screened for eligibility in their first or early second trimester of pregnancy (13-17 weeks of GA) and will be enrolled and randomized into three arms (48 women per arm). Participants will be dosed depending on the randomized arm.
As per WHO recommendation, participants in all 3 arms will receive Multiple Micronutrient Supplements (MMS) as part of routine antenatal care, which they will begin taking at enrollment and continue throughout pregnancy.
Blinding will be implemented for the comparison between the Treatment arm and the Placebo arm. However, it is not feasible to apply blinding to the Observation-only arm as the participants in this group will receive no intervention and the arm solely serves as an observational arm.
After the end of the intervention, pregnant women will be followed up until birth to record birth and pregnancy outcomes. Mother-infant dyads will be sampled 7 days after birth. Maternal and Infant health outcomes will be followed up to 1 month after childbirth to record clinical outcomes during this period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Observation only arm | No intervention | – |
| oral vancomycin + placebo | Placebo comparator | Drug: Placebo, Drug: Oral Vancomycin |
| oral vancomycin + VE818 | Active comparator | Drug: VE818, Drug: Oral Vancomycin |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 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
- AND
- 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.
- AND
- 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 |
|---|---|---|
| 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 |
| 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 + VE818, oral vancomycin + placebo |
Primary outcome
Change in the mean count in the number of 11 selected fecal bacterial pathogen groups present between baseline and endline
Time frame: Between baseline 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 baseline 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
Time frame: Baseline, day 6, day 21, day 35, day 63 and 7 day post-partum
Engraftment of VE818 strains in pregnant women
Time frame: day 21, day 35, day 63 and 7 day post-partum
Change in a panel of plasma biomarkers in pregnant women as measured by ELISA
Time frame: Baseline, day 6, day 35, and day 63
Change in a panel of fecal biomarkers in pregnant women as measured by ELISA
Time frame: Baseline, day 6, day 21, day 35, day 63 and 7 day post-partum
Change in intestinal permeability as measured by Lactulose/Rhamnose (LR) ratio in pregnant women
Time frame: Baseline and day 35
Change in alpha and beta diversity of fecal microbiome in pregnant women
Time frame: Baseline, day 6, day 21, day 35, day 63 and 7 day post-partum
Change in alpha and beta diversity of vaginal microbiome in pregnant women
Time frame: Baseline, day 6, day 35, and day 63
Change in alpha and beta diversity of oral microbiome in pregnant women
Time frame: Baseline and day 35
Change in metabolome (plasma and stool) in pregnant women
Time frame: Baseline, day 6, day 21, day 35, day 63 and 7 day post-partum
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 10 Dec 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 VE818 and Oral Vancomycin in people with Environmental Enteric Dysfunction, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 1 site in Bangladesh.
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 10 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: enrolling by invitation, as of the sponsor's last update on 10 Dec 2025. 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 Bangladesh. 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 in the number of 11 selected fecal bacterial pathogen groups present between baseline and endline (time frame: Between baseline 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 10 Dec 2025.