NCT02725255

Design and Clinical Evaluation of a School Meal With Deworming Properties

Completed Phase 2/Phase 3 Last updated 3 September 2016

What this trial tests

Phase 2/Phase 3 trial testing Ujiplus in Helminthiasis in 326 participants. Completed in 1 March 2016.

Timeline

1 May 2015

Primary endpoint
1 November 2015

1 March 2016

Quick facts

Lead sponsor	Kenya Medical Research Institute
Phase	Phase 2/Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	326
Start date	1 May 2015
Primary completion	1 November 2015
Estimated completion	1 March 2016

Drugs / interventions tested

• Ujiplus
• Albendazole (ALBENDAZOLE) — full drug profile →
• uji

Conditions studied

• Helminthiasis — all drugs for Helminthiasis →
• Tinea Capitis — all drugs for Tinea Capitis →
• Anemia — all drugs for Anemia →

Sponsor

Kenya Medical Research Institute

Who can join

Adults 4 to 12, any sex, with Helminthiasis or Tinea Capitis. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• parasite egg count
  Time frame: 60 days after randomization
  ova and cyst counts of various helminths in stool sample at end of intervention

Sponsor's own description

Intestinal parasites (IP) are among the world's neglected tropical diseases. Morbidity due to IPs is greatest in school-age children who typically have the highest burden of infection. In 2001, WHO passed a resolution for the use of large-scale mass drug administration (MDA) of antihelminthic drugs to deworm children in developing countries. Though initially effective, there is concern that MDA might not be sustainable over extended periods especially considering the large children populations and the high frequency of dosing. Further, the MDAs exert increasing drug pressure on parasite populations, a circumstance that is likely to favor parasite genotypes that can resist anthelmintic drugs. There is hence a need for alternatives that are not only affordable and sustainable but easier to implement in the long term with a minimal chance of development of resistance. The investigators propose to develop and test the feasibility of a corn porridge meal fortified with papaya fruit extracts that have been shown to have antihelminthic properties. The investigators intend to evaluate its efficacy when given through school feeding programs and compare the outcome with albendazole- the recommended MDA agent for deworming school children. The investigators will design and formulate the product and test it among children in three primary schools in Western Kenya.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Public health deworming programmes for soil-transmitted helminths in children living in endemic areas.
   Taylor-Robinson DC, Maayan N, Donegan S, Chaplin M, et al · · 2019 · cited 46× · PMID 31508807 · DOI 10.1002/14651858.cd000371.pub7
2. Fortification of Carica papaya fruit seeds to school meal snacks may aid Africa mass deworming programs: a preliminary survey.
   Kugo M, Keter L, Maiyo A, Kinyua J, et al · · 2018 · cited 5× · PMID 30526582 · DOI 10.1186/s12906-018-2379-2