Clinical Evaluation of Ujiplus® Against Schistosoma Mansoni
Status:
Not yet recruiting
Trial end date:
2021-04-30
Target enrollment:
Participant gender:
Summary
Schistosomiasis is classified as among the world's neglected tropical diseases (NTD).
Morbidity due to Schistosoma mansoni (S. mansoni) is greatest among school-age children who
typically have the highest burden of infection. In 2001, World Health Organization (WHO)
passed a resolution for large-scale mass drug administration (MDA) using chemotherapy to
deworm vulnerable children through school-based programs. While MDA has significantly
contributed to reducing the burden of these infections, several concerns still exist over the
large-scale use of chemotherapeutic drugs in deworming. The large population of children and
the high frequency of dosage may pose a challenge to the sustainability of these programs.
Further, the MDAs exert increasing drug pressure on parasite populations, a circumstance that
is likely to favor parasite genotypes that can resist chemotherapy. Additionally, the current
school-based MDA does not consider child malnutrition a very common malady in African
countries. The greatest shortcoming is that currently approved S. mansoni chemotherapeutic
treatment, Praziquantel is not recommended for children under six years of age due to its
perceived toxicity. This excludes a highly vulnerable group from treatment.
The above has called for alternative management options for S. mansoni among school and
pre-school age children. The current study seeks to test the feasibility of the use of a
nutritional supplement (Ujiplus®), as a potential deworming strategy against S. mansoni.
Ujiplus® is a porridge flour fortified with papaya (Carica papaya) seeds extracts. In a
previous study (NCT 027-25255), the product was found to have an effect on soil-transmitted
helminths among a group of school children with no serious adverse events. We intend to
evaluate the efficacy of Ujiplus® when given through school feeding programs and compare the
outcome with praziquantel- the recommended MDA agent for deworming school children. The
investigators will design and formulate the Ujiplus®, and test it among children in four
primary schools in Mbita, Homabay county, Kenya.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Kenya Medical Research Institute
Collaborators:
Kanazawa University Terik Essential Programs Agency for Development, Kenya