Clinical teams in Pakistan launch groundbreaking maternal probiotic study to address EED and stunting. This pilot intervention aims to enhance gut health using regulated drug therapies.
The study is recruiting participants as of October 2025.
In this article:
What is the study about?
A clinical trial named “Maternal Probiotic Intervention to Improve Gut Health-Trial II-Pakistan” is recruiting candidates to address two major public health challenges: Environmental Enteric Dysfunction (EED) and stunting. Both conditions severely impact childhood development and long-term health, particularly in low-resource environments.
EED is characterized by chronic inflammation and poor absorption in the intestinal tract, which impairs nutritional intake. Stunting, a condition marked by reduced growth and development, often stems from inadequate nutrition and unsanitary living conditions. This study aims to explore whether maternal probiotics during pregnancy and early postnatal periods can equip offspring with improved gut health, paving the way for preventive outcomes against stunting.
What interventions are being tested?
The trial will evaluate the safety and efficacy of three intervention arms:
- Oral Vancomycin: A well-known antibiotic.
- VE818: A novel probiotic drug candidate designed for gut microbiota modulation.
- Placebo: Used as the control to measure the efficacy of the two active interventions.
Patients will be randomly assigned to one of these arms under strict regulatory protocols to ensure compliance with patient safety and informed consent regulations.
According to manufacturer documentation, VE818 has demonstrated promising data in initial studies for rebalancing gut flora—an important factor in preventing EED and stunting. The collaboration emphasizes robust clinical oversight to address regulatory requirements.
Who is conducting the research?
This trial is a joint effort among internationally recognized health organizations:
- Aga Khan University: Leading local research efforts in Pakistan.
- Bill and Melinda Gates Foundation: Funding global health innovation.
- International Centre for Diarrhoeal Disease Research, Bangladesh: Providing scientific expertise.
- University of Zambia: Contributing regional knowledge.
- Institut Pasteur de Dakar: Offering microbiology support.
The collaborative approach ensures the trial is conducted leveraging diverse perspectives on EED and stunting prevention strategies in both local and global contexts.
FAQ
- Who is eligible for the trial?
Pregnant women meeting specific eligibility criteria will be invited to participate. Full inclusion and exclusion criteria are accessible through the official trial link. - Why is stunting prevention urgent?
Stunting affects millions of children worldwide, limiting their physical, cognitive, and economic potential. Addressing this issue in the maternal phase can have long-term benefits. - Are these interventions approved?
Vancomycin is an established antibiotic. VE818 remains under clinical investigation. All interventions in this study are conducted under stringent regulatory oversight.
Conclusion
This trial highlights Pakistan’s proactive role in global health research addressing entrenched developmental challenges like EED and stunting. Regulatory, clinical, and quality professionals should monitor this study’s progress to evaluate its potential contributions to public health frameworks.
Disclaimer
This article is intended for informational purposes only and is not legal or regulatory advice. Always consult official resources.
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07207434?term=medical+device