Clinical Evaluation of Ujiplus® Against Schistosoma Mansoni
Condition: Schistosoma Mansoni
Study type: Interventional
Phase: Phase 2/Phase 3

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.
    

Detailed description: 
      Background: 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. Moreover,
      chemotherapeutic drugs are not recommended for children under the age of 6 years due to their
      toxicity, despite the fact that this is the age group most infected with S. mansoni.
      Additionally, the current school-based MDA does not consider child malnutrition a very common
      malady in African countries.

      Based on the above, we have designed a nutritional food supplement, Ujiplus®, with the
      potential as a homegrown mass drug administration tool against intestinal parasites including
      S.mansoni. Porridge (Uji) made from corn flour is one of the most prevalent traditional
      school meal snacks in developing countries. Because of its low cost, and popularity in
      schools, it has been adopted as a component in school meals, often prepared and given as a
      snack at break time. To enhance its effect, we have fortified the Uji flour with
      micronutrients and extracts from papaya (Carica papaya) seeds to form Ujiplus®. Carica papaya
      seeds have been found in various studies to have an anthelminthic effect with benzyl
      isothiocyanate (BITC) as the potential active ingredient. In a previous clinical trial,
      Ujiplus® reduced the Ascaris lumbricoides egg count by 63.9% after the two month period as
      compared to the albendazole arm, 78.8%.

      In this study, primary school children (ages 6-8) from four schools in Homabay County Kenya
      will be randomized into two arms: Children from two schools will receive 300 ml Ujiplus®
      porridge daily (test school), and the other two schools will receive a similar serving of
      plain porridge (cornflour and micronutrients only) with Praziquantel. Prior to the
      randomization, an initial baseline stool microscopy analysis will be done to determine the
      presence and intensity of intestinal worms. Core indicators of nutrition-height, weight, and
      hemoglobin counts-will also be assessed. The children will be monitored daily for three
      months and final stool sample analysis and clinical monitoring done at the end of the study.
      Baseline and follow-up data will be collected through Redcap software (Vanderbilt, Nashville,
      Tenn) analyzed and compared through the latest software of SAS statistical package.
    

Intervention name(s): Ujiplus®; Praziquantel 400mg
Intervention type(s): Dietary Supplement; Drug
Intervention description(s): Ujiplus® flour, a nutritional supplement will be used to prepare porridge, and each child will be given a serving of 300 ml every school day for 90 days.; 400mg of Praziquantel will be given to each child once at the beginning of the study and maize flour porridge fortified only with micronutrients cooked and served to each child, 300 ml per every school day for 90 days,
Other intervention name(s): Biltricide
Intervention MeSH terms: Praziquantel
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Dietary Supplement: Ujiplus Ujiplus flour, a nutritional supplement. The flour will be used to prepare porridge and each child is given a serving of 300 ml every school day for 90 days.
Masking: Single (Investigator)
Primary purpose: Treatment