- 2016-11
- Journal of clinical gastroenterology 50(Supplement 2)
- Mario Del Piano
- Francesco Coggiola
- Marco Pane
- Angela Amoruso
- Stefania Nicola
- Luca Mogna
Study Design
- Type
- Randomized Controlled Trial (RCT)
- Population
- 4000 infants (babies) in Luzira, Gulu, and Lira, Uganda
- Methods
- open-label, randomized controlled study; probiotic composed of Bifidobacterium breve BR03, B. breve B632, and Lactobacillus delbrueckii subsp. delbrueckii LDD01, 10 viable cells/strain/daily dose; control group of 2000 babies; followed till 1 year
- Blinding
- Open-label
- Duration
- 1 year
- Funding
- Unclear
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.