The PRoRota-project will use probiotics, improved education in hygiene and advanced mathematical models to prevent children from dying of diarrhea in low and middle-income countries.
Diarrhea kills nearly two million lives every year and is one of the main causes of child deaths globally. Rotavirus is one of the most important causes of childhood diarrhea, and vaccines against the virus have reduced the incidences of diarrhea:
However, the vaccines efficacies remain significantly lower in developing countries compared to high income countries."
Sabrina Moyo, researcher from the Tropical Infectious Diseases Group, Department of Clinical Science, UiB
She is the project leader of the project PRoRota, who just recently was given 5 300 000 Euros from the EU over four years, to try to enhance the efficacy of the vaccines in low to middle income countries. From the Tropical Infectious Diseases Group, Sabrina Moyo, Nina Langeland and Bjørn Blomberg are the main researchers in the project.
Used of probiotics to improve infants' gut microbiota
The project hypothesis is that the low vaccine efficacy is related to the children's gut microbiota. Moyo explains:
"In our guts we have both "good" and "bad" bacteria. The microbiota in our guts is affected by both hygiene and nutrition, and other factors".
In a previous study performed at children in Tanzania, the research group found a high rate of resistant bacteria in the gut of children less than three months old.
In a later project, they tested the effect of giving probiotic to infants. The hypothesis was that the intake of probiotics would increase the number of "good" bacteria, and reduce the amount of multi-resistant bacteria in the gut:
"We observed that those who had received probiotics daily for one month, had a reduction of resistant bacteria in the gut, compared to the control group", says Moyo.
The children also had an increased proportion of "good" bacteria in the gut compared to the control group. However, stool samples taken 6 months after the intervention showed that the effect was relatively short-lived.
Could probiotics also increase vaccine immune responses?
Now, the researchers are eager to see if repeated doses of probiotics prior to standard childhood immunization enhances the effect of the rotavirus vaccination.
"Very few studies have looked at how probiotic affects vaccination. In PRoRota we will give probiotics from birth, and for longer periods", Moyo explains.
"Our hypothesis is that probiotics can, through improving a destabilized gut microbiome, increase the vaccine immune responses".
To test this, the researchers will conduct a double-blind, placebo-controlled trial in 4000 newborns across Tanzania, Malawi, and the Ivory Coast.
The infants included will be randomized to receive four-week courses of probiotics or placebo at birth and at 6, 10, and 14 weeks of age, and followed until 6 months to measure diarrhea incidence (primary outcome), immune response to the rotavirus vaccine, and risk of multidrug-resistant bacterial gut colonization (secondary outcomes).
The study includes five international partners, from the four countries involved in the project (Norway, Tanzania, Ivory Coast and Malawi).
Better hygiene education
The project also includes a work package where the researchers will look at the implementation of training for better hygiene routines for the caretakers.
"We know that hygiene and sanitation not optimal", says Moyo.
Routinely the mothers are given what the researchers call "Water, Sanitation, and Hygiene" (WASH) education, but they have seen that the implementation of the routine is not good enough:
"In the study, all groups will receive an enhanced "WASH" education, and we will study what is needed to make the WASH-education work", Moyo explains.
Improved cost effectiveness
Together with this the group will also look at the cost effectiveness of the different measures.
Researcher Amani Mori at the Department of Global Public Health and Primary Care is responsible for this part of the PRoRota project. How will the intervention improve the health costs in the countries?
"We know that care takers of sick children spend more time going to and from the hospital and less time working", says the researcher.
Sick children will also increase the pressure on an already pressed health economy in these low to middle-income countries.
A mathematical tool to predict future outbreaks
Another work package includes making a prediction tool to foresee rotavirus outbreaks.
Professor Iain Johnston at the Faculty of Science and Technology at the UiB will use temperature and precipitation data coupled with rotavirus infection data in Tanzania, Malawi and the Ivory Coast during the period 2015-2025 to develop a model that could predict the future:
"The creation of early-warning systems for outbreak prediction, could be an important tool for the Health Administration of these three countries", says Moyo.
The main goal of the project is, however, to reduce diarrhea incidence, reduce the number of drug-resistant bacteria in the gut of the children, and improve the immune response to rotavirus.
None of this would be possible without the generous support of the EU, as Moyo confirms: "This funding means that we are able realize all our plans".
Partners in the PRoRota project:
1. Coordinator: University of Bergen, Norway
2. Partner: Muhimbili University of Health and Allied Sciences, Tanzania
3. Partner: National Institute for Medical Research, Tanzania
4. Partner: Association PAC-Ci CI IC, Ivory Couast ASSOCIATION PAC-CI CI IC; Ivory Coast
5. Partner: Training & Research Unit of Excellence Limited, Malawi.