Contacts

Rotalactis S.r.l.
Via Ribes, 5 - 10010
Colleretto Giacosa (TO)
Italy
Tel 0039 0125-561000

Mission

The Problem addressed

The rotavirus is the most important cause of severe gastroenteritis in children (under five years).
The virus is spread by oro-faecal route and targets the mature enterocytes of the apical villi of the small intestine, causing severe gastroenteritis, usually with complete healing and no sequelae.
The infection is, however, cause of death in infants malnourished and dehydrated, especially in underdeveloped countries, since mortality is associated with dehydration and electrolyte imbalance.

The Solution

Objective of Rotalactis for the three years funded by Eporgen is the development of a dietary supplement derived from equine milk for the prevention of neonatal infection by rotavirus. The product is targeted primarily for babies who are not breastfed and therefore can not enjoy the natural protection provided by breast milk, but could also be used to enrich milk for growth.

Epidemological aspects of gastroenteritis caused by the rotavirus

According to the World Health Organization (WHO), the rotavirus is the most serious cause of gastroenteritis in children under 5 years of age. Every year this pathology provokes around 25 million visits to the doctor, 2 million hospitalizations and 500,000 deaths, especially in children under 2 years of age [1].
85% of these deaths occur in developing countries where the poor hygiene conditions contribute to the difficulty in accessing rehydration therapy and other medical care. In 2004, it was estimated that 527,000 children worldwide died from gastroenteritis caused by the rotavirus and 65% of these deaths occurred in the 11 developing countries reported in the figure below (WHO source).

For the previously described motives, this disease is considered to be a real health emergency by WHO. Moreover, the fight against this infection was identified as a priority area by the Melinda and Bill Gates Foundation.

Even in the richer countries, gastroenteritis caused by the rotavirus is widespread thug rarely lethal. The disease is associated with a heavy cost in health expenditure, including the direct costs (medical visits, therapy and recoveries in hospital) and the social costs (days of sick leave taken from work)[2]. In the USA, the rotavirus is responsible for over 400,000 visits to the doctor every year, more than 200,000 admissions to “A&E”, between 55,000 and 70,000 recoveries in hospital and 20-60 deaths in children under 5 years of age [3]. Every year in Europe, the rotavirus is responsible for around 230 deaths, 87,000 recoveries in hospital, 700,000 visits to the doctor and 2.8 million episodes of illness at home [1].

In Italy, it is estimated that every year infections from the rotavirus cause more than 300,000 cases which are cured at home, more than 80,000 visits to the doctor, around 10,000 recoveries in hospital and 10 deaths [4].

Epidemology and clinical symptoms

Infection caused by the rotavirus is a widespread endemic infection and is occasionally associated with epidemics. In countries with temperate climates, the virus has seasonal characteristics, peaking in the winter, whereas in tropical countries, the virus is present all year round with the occasional peak in cases.

The infection is transmitted via the faecal-oral route but may also be transmitted by inhalation or through physical contact. The incubation period is between 36 to 48 hours and the infected patient may still eliminate the virus in feces for 2-5 days after the last episode of diarrhea. There is no specific clinical description of gastroenteritis caused by the rotavirus. Acute episodes are characterized by a moderate fever, gastric disturbance, vomiting and watery diarrhea for 3-8 days, which may also have a longer duration of up to 3 weeks. With respect to most cases of gastroenteritis, the infection in milk-fed babies leads more frequently to dehydration.

Nearly all the population is exposed to rotavirus infections within the first few years of life. The incidence of infection is higher in young children and babies than in adolescents and adults, where there are less important clinical symptoms and may remain asymptomatic, though still representing a possible source of infection within a family unit.

Rotalactis’ approach to the problem

Currently there are NO medicines available to specifically treat the rotavirus infections and the only possible treatment for gastroenteritis caused by the rotavirus is a reintegration with liquids and correction of the body’s electrolyte balance.

The limitations and social acceptability of vaccines against the rotavirus, due to demonstrated serious collateral effects or because of viral contamination of the vaccine preparation, has caused the withdrawal of 2 of the 3 commercially available vaccines.

In this context, Rotalactis’ product, administered as a dietary supplement, would have a large social impact, as it would be easily accepted by parents and children.

The innovative strategy of Rotalactis consists of identification of an equine (donkey) milk protein and its derivative peptides, which impede the contact between the rotavirus and the target cells thus preventing infection. These products will be used as dietary supplements for infants or as ingredients to improve the quality of formula milk.