Environmental Enteric DysfunctionPhase 2MPIGHNCT05922683
Maternal Probiotic Intervention to Improve Gut Health
A Phase 2 study testing Vivomixx and CapScan® in people with Environmental Enteric Dysfunction and Stunting, run by Aga Khan University at 1 site in Pakistan.
Trial summary
There is an urgent need to identify interventions that can improve the supportive uterine environment in which the fetus establishes his/her growth. Investigators believe that this necessitates improving the delivery of nutrients to the mother, and in turn that requires a healthy microbiota. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Environmental Enteric Dysfunction, Stunting
- What is being tested?
- Vivomixx and CapScan®
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 sitePakistan
- Study dates
- 9 Aug 2023to 30 Jun 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 over the age of 18 in their second trimester of pregnancy living in defined geographical areas of Matiari, where it can be assumed that environmental enteropathy is universal.
Who cannot join
- 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 non-steroidal anti-inflammatory drugs or steroids in the preceding 14 days;
- have haemoglobin concentration <8g/dl;
- have any illness which in the opinion of the investigator will complicate assessment of safety or efficacy;
- 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 leave the study area within the follow-up period;
- 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
Matiari, Sindh, 71000
About this study
Official title: Ability of the Probiotic Vivomixx to Improve Environmental Enteropathy in Pregnant Women: a Proof of Concept Trial in Bangladesh, Pakistan, Senegal, and Zambia
There is an urgent need to identify interventions that can improve the supportive uterine environment in which the fetus establishes his/her growth. Investigators believe that this necessitates improving the delivery of nutrients to the mother, and in turn that requires a healthy microbiota. Reducing intestinal inflammation will also have a profound impact on maternal and fetal immunity, though there is limited information on the impact of maternal health on placental function. This trial will determine if a well-established probiotic, Vivomixx, can modulate the maternal microbiota and ameliorate the maternal environmental enteropathy which compromises growth in the first 1000 days. This trial is the first in a proposed series of proof-of-concept intervention studies that are intended to provide data to enable a rational selection of interventions to be evaluated at scale in future large-scale trials.
This initial study will also serve the purpose of developing a harmonized multi-site Experimental Medicine Platform across four countries (Bangladesh, Pakistan, Senegal, Zambia). Harmonized procedures will develop the capacity to deliver high-quality trials for the evaluation of potential interventions to improve maternal nutritional status and growth in utero. To this end, measuring and understanding variability in endpoint measurements is a key deliverable.
Read the detailed description
76 healthy pregnant women in their second trimester will be enrolled and will be randomized to receive either probiotic or placebo for 8 weeks. It will be a double-blind trial.
Pregnant women will be recruited in the community through 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 taken in which investigators will assess them clinically and will measure their hemoglobin level and gestational ultrasound for confirmation of their trimester/gestational weeks. Based on the screening results and clinical staff assessment, women will be enrolled after taking trial participation consent.
Once the participant is enrolled, investigators will collect blood, urine LR, and stool samples (flash frozen and CapScan) before giving either a placebo or probiotic(which will be replenished after every 3 days). investigators will then follow them weekly for compliance and adverse event data collection for 56 days (8 weeks). investigators will again collect the same blood and stool samples after completion of 56 days. An additional visit at 36 weeks will be done to record weight and for a gestational ultrasound. Pregnancy outcomes will be recorded and then the child will be followed at 3,6,9 and 12 weeks for anthropometry and morbidity data collection. Gestational ultrasounds will be performed at screening at 20, 28 and 36 weeks of gestation.
- Conditions
- Environmental Enteric Dysfunction, Stunting
- Being tested
- Vivomixx, CapScan®
- Keywords
- probiotic, microbiome, pregnant women, capscan device, urine LR, vivomixx, 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.
VivomixxDrug
Also called VSL#3
Vivomixx (a mixture of Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus casei, Lactobacillus delbrueckii subspecies bulgaricus, Streptococcus salivarius subspecies thermophiles, Bifidobacterium breve, Bifidobacterium longum, and Bifidobacterium infantis), as VivomixxAll consenting participants will be randomized into the treatment to control arm, receiving either Vivomixx or a placebo for 8 weeks.
During the study, women will visit the healthcare center or vice-versa on a bi-weekly basis to receive sachets of Vivomixx or a placebo according to their trial arm.
CapScan®Device
The only non-standard sample collection instrument is the CapScan device. The CapScan Collection Capsule ("Capsule") is a non-invasive device that collects gastrointestinal samples along the GI tract that are then analyzed outside the body. Samples collected by the Capsule will be expressed, then undergo DNA sequencing and mass spectrometric analysis to determine the identity and function of the bacterial and host cells in the different regions of the GI tract and compared to similar analyses conducted on concomitantly collected stool samples.
| Study group | Role | What they receive |
|---|---|---|
| Vivomixx | Experimental | Participant in the treatment arm will receive a daily dose of the probiotic Vivomixx for 8 weeks. Receives: Drug: Vivomixx; Device: CapScan® |
| Placebo | Placebo comparator | Participant in the control arm will receive a daily dose of a placebo (microcrystalline maltose) for 8 weeks. Receives: Device: CapScan® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in inflammation and epithelial damage in pregnant women with environmental enteropathy
Percentage change (mean, unweighted) in a multiple panels of biomarkers between baseline and last sample collected after 56 days of treatment, compared to a control group.
Measured: Day 0 (screening) - Day 56
Secondary outcomes (6)
Reduction in enteropathogen colonisation
Reduction in colonisation with specific enteropathogens (Salmonella, Shigella, Campylobacter, ETEC, EPEC, EAEC, rotavirus, norovirus, Giardia and Cryptosporidium), by qPCR, between baseline and last sample collected after 56 days of treatment, in Vivomixx compared to placebo groups
Measured: Day 1 - Day 56
Impact of Vivomixx on the structure and function of the microbiome
Change in relative abundance values of alpha and beta diversity pre- and post-treatment samples.
Measured: Day 1 - Day 56
Vivomixx Reduction in permeability
Reduction in LR ratio in Vivomixx compared to placebo groups
Measured: Day 1 - Day 56
Impact of the host metabolome in pregnant woman
Change in the metabolome, Untargeted urine, and plasma (and fecal) metabolome before and after the intervention.
Measured: Day 1 - Day 56
Rate of weight gain in the 2nd trimester of pregnancy
Weight gain velocity in the 2nd trimester of pregnancy
Measured: Day 1 - Day 56
Variability in endpoints across geographies and participating laboratories
Measurements of variability, including standard deviations and kappa values; Preliminary work across all sites using identical kits and harmonised SOPs
Measured: Day 1 - Day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2023
- Study start9 Aug 2023
- Primary completion30 Jun 2024
- Study completion30 Jun 2025
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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 76 participants (actual)
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, MPH, Principal investigator, Aga Khan University Hospital, Karachi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05922683
- Sponsor's protocol ID
- 51975
- Acronym
- MPIGH
- Status last verified
- Jul 2025
- First submitted
- 20 Jun 2023
- Last updated
- 16 Jul 2025
- 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 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ability of the Probiotic Vivomixx to Improve Environmental Enteropathy in Pregnant Women: a Proof of Concept Trial in Bangladesh, Pakistan, Senegal, and Zambia
- ClinicalTrials.gov ID
- NCT05922683
- Acronym / sponsor ID
- MPIGH / 51975
- Conditions
- Environmental Enteric Dysfunction, Stunting
- Keywords
- probiotic, microbiome, pregnant women, capscan device, urine LR, vivomixx, pakistan, malnourished children
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- 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
- 9 Aug 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 28 Jun 2023 (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.
There is an urgent need to identify interventions that can improve the supportive uterine environment in which the fetus establishes his/her growth. Investigators believe that this necessitates improving the delivery of nutrients to the mother, and in turn that requires a healthy microbiota. Reducing intestinal inflammation will also have a profound impact on maternal and fetal immunity, though there is limited information on the impact of maternal health on placental function. This trial will determine if a well-established probiotic, Vivomixx, can modulate the maternal microbiota and ameliorate the maternal environmental enteropathy which compromises growth in the first 1000 days. This trial is the first in a proposed series of proof-of-concept intervention studies that are intended to provide data to enable a rational selection of interventions to be evaluated at scale in future large-scale trials.
This initial study will also serve the purpose of developing a harmonized multi-site Experimental Medicine Platform across four countries (Bangladesh, Pakistan, Senegal, Zambia). Harmonized procedures will develop the capacity to deliver high-quality trials for the evaluation of potential interventions to improve maternal nutritional status and growth in utero. To this end, measuring and understanding variability in endpoint measurements is a key deliverable.
Detailed description
76 healthy pregnant women in their second trimester will be enrolled and will be randomized to receive either probiotic or placebo for 8 weeks. It will be a double-blind trial.
Pregnant women will be recruited in the community through 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 taken in which investigators will assess them clinically and will measure their hemoglobin level and gestational ultrasound for confirmation of their trimester/gestational weeks. Based on the screening results and clinical staff assessment, women will be enrolled after taking trial participation consent.
Once the participant is enrolled, investigators will collect blood, urine LR, and stool samples (flash frozen and CapScan) before giving either a placebo or probiotic(which will be replenished after every 3 days). investigators will then follow them weekly for compliance and adverse event data collection for 56 days (8 weeks). investigators will again collect the same blood and stool samples after completion of 56 days. An additional visit at 36 weeks will be done to record weight and for a gestational ultrasound. Pregnancy outcomes will be recorded and then the child will be followed at 3,6,9 and 12 weeks for anthropometry and morbidity data collection. Gestational ultrasounds will be performed at screening at 20, 28 and 36 weeks of gestation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vivomixx | Experimental | Drug: Vivomixx, Device: CapScan®Participant in the treatment arm will receive a daily dose of the probiotic Vivomixx for 8 weeks. |
| Placebo | Placebo comparator | Device: CapScan®Participant in the control arm will receive a daily dose of a placebo (microcrystalline maltose) for 8 weeks. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women over the age of 18 in their second trimester of pregnancy living in defined geographical areas of Matiari, where it can be assumed that environmental enteropathy is universal.
Key exclusion criteria (8 listed)
- 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 non-steroidal anti-inflammatory drugs or steroids in the preceding 14 days;
- have haemoglobin concentration <8g/dl;
- have any illness which in the opinion of the investigator will complicate assessment of safety or efficacy;
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 |
|---|---|---|
| VivomixxAlso: VSL#3Vivomixx (a mixture of Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus casei, Lactobacillus delbrueckii subspecies bulgaricus, Streptococcus salivarius subspecies thermophiles, Bifidobacterium breve, Bifidobacterium longum, and Bifidobacterium infantis), as VivomixxAll consenting participants will be randomized into the treatment to control arm, receiving either Vivomixx or a placebo for 8 weeks. During the study, women will visit the healthcare center or vice-versa on a bi-weekly basis to receive sachets of Vivomixx or a placebo according to their trial arm. | Drug | Vivomixx |
| CapScan®The only non-standard sample collection instrument is the CapScan device. The CapScan Collection Capsule ("Capsule") is a non-invasive device that collects gastrointestinal samples along the GI tract that are then analyzed outside the body. Samples collected by the Capsule will be expressed, then undergo DNA sequencing and mass spectrometric analysis to determine the identity and function of the bacterial and host cells in the different regions of the GI tract and compared to similar analyses conducted on concomitantly collected stool samples. | Device | Placebo, Vivomixx |
Primary outcome
Reduction in inflammation and epithelial damage in pregnant women with environmental enteropathy
Time frame: Day 0 (screening) - Day 56
Percentage change (mean, unweighted) in a multiple panels of biomarkers between baseline and last sample collected after 56 days of treatment, compared to a control group.
6 secondary outcomes
Reduction in enteropathogen colonisation
Time frame: Day 1 - Day 56
Impact of Vivomixx on the structure and function of the microbiome
Time frame: Day 1 - Day 56
Vivomixx Reduction in permeability
Time frame: Day 1 - Day 56
Impact of the host metabolome in pregnant woman
Time frame: Day 1 - Day 56
Rate of weight gain in the 2nd trimester of pregnancy
Time frame: Day 1 - Day 56
Variability in endpoints across geographies and participating laboratories
Time frame: Day 1 - Day 56
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
- Individual participant dataSharing planned: Yes. De-identified individual data for all primary and secondary outcome measures will be made available.
Related trials for Environmental Enteric Dysfunction
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Glucagon-like Peptide 2 (GLP-2) in Undernourished Women Improving From Histology-Confirmed Environmental Enteric Dysfunction (EED)
Environmental Enteric Dysfunction
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, MPH principal investigator
Aga Khan University Hospital, Karachi
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 Vivomixx and CapScan® in people with Environmental Enteric Dysfunction 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 1 inclusion and 8 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: finished, as of the sponsor's last update on 16 Jul 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Reduction in inflammation and epithelial damage in pregnant women with environmental enteropathy (time frame: Day 0 (screening) - Day 56). 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 16 Jul 2025.