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Can Probiotics Reduce Diarrhea and Infant Mortality in Africa?: The Project of a Pilot Study
Mario Del Piano1, Francesco Coggiola, Marco Pane
1*Gastroenterology Department, Santa Rita Hospital-Policlinico di Monza †Department of Gynecology and Obstetrics, Santa Rita Hospital-Policlinico di Monza, Vercelli ‡Biolab Research Ltd, Novara, Italy.
Insights
This study investigates a probiotic intervention to reduce diarrhea and infectious diseases in Ugandan infants, aiming to decrease infant mortality. The research focuses on improving child survival rates through targeted microbial therapy.
Area of Science:
- Pediatrics
- Microbiology
- Public Health
Background:
- Diarrhea is a leading cause of mortality in children under five globally, particularly in sub-Saharan Africa.
- Infant mortality in Uganda is high, with malnutrition and infectious diseases like diarrhea and pneumonia as major contributors.
- There is a critical need for effective interventions to prevent and manage diarrheal diseases in vulnerable populations.
Purpose of the Study:
- To evaluate the efficacy of a specific probiotic formulation in reducing the incidence and severity of diarrhea and infectious diseases in infants.
- To assess the impact of the probiotic intervention on infant mortality rates in the study population.
- To provide evidence-based strategies for controlling diarrheal diseases and improving child survival in low-resource settings.
Main Methods:
- An open-label, randomized controlled trial involving 4000 infants in Uganda (2000 treatment, 2000 control).
- The probiotic intervention consists of a daily dose of three microorganisms: Bifidobacterium breve BR03, B. breve B632, and Lactobacillus delbrueckii subsp. delbrueckii LDD01.
- Infants will be followed for one year to assess primary endpoints (diarrhea and infectious disease episodes/severity) and secondary endpoint (infant mortality).
Main Results:
- The study is powered to detect significant differences with 80% power at a 5% significance level for a total sample of 4000 babies.
- Primary endpoint: reduction in diarrhea and infectious diseases (number of episodes/severity).
- Secondary endpoint: decrease in infant mortality.
Conclusions:
- The findings will inform the potential use of probiotics as a public health intervention to combat childhood diarrhea and reduce infant mortality in Uganda.
- This research addresses a significant public health challenge by exploring novel therapeutic approaches for infectious diseases in infants.
- Successful outcomes could lead to scalable and cost-effective strategies for improving child health in similar settings worldwide.
Background:
Diarrhea accounts for 9% of the mortality among children under 5 years of age worldwide, and it is significantly associated with malnutrition. Each year, diarrhea kills around 760,000 children under 5 years of age and most of these are in sub-Saharan Africa.In Uganda, the infant mortality rate of 58 per 1000 is unacceptably high, and the major contributors include malnutrition, diarrhea, pneumonia, malaria, prematurity, sepsis, and newborn illnesses.There is an urgent need for intervention to prevent and control diarrheal diseases.
Study Design:
Our open-label, randomized controlled study has the primary endpoint of reducing diarrhea and infectious diseases (number of episodes/severity) and the secondary endpoint of decreasing infant mortality. The trial is currently conducted in Luzira, a suburb of Kampala, the capital of Uganda, and in Gulu and Lira, in the north of Uganda.The study is projected to enroll 4000 babies (control=2000 and treatment=2000) who will be followed till 1 year of life. As controls, 2000 babies of the same community are planned to be considered.The probiotic product selected for the trial is composed of 3 designated microorganisms, namely Bifidobacterium breve BR03 (DSM 16604), B. breve B632 (DSM 24706), and Lactobacillus delbrueckii subsp. delbrueckii LDD01 (DSM 22106). The concentration of the 3 bacteria is 10 viable cells/strain/daily dose (5 drops).
Perspectives:
For a total sample of 4000 babies, the study has an 80% power at a 5% significance level.
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