Schistosoma Mansoni Clinical Trial
Official title:
Clinical Evaluation of Ujiplus®, a Porridge Snack With Deworming Properties for Activity Against Schistosoma Mansoni
Verified date | July 2022 |
Source | Kenya Medical Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 400 |
Est. completion date | March 30, 2022 |
Est. primary completion date | March 30, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Years to 8 Years |
Eligibility | Inclusion Criteria: - Consenting parents and guardians Exclusion Criteria: - Children with known allergy to papaya fruit products |
Country | Name | City | State |
---|---|---|---|
Kenya | Mbita | Mbita |
Lead Sponsor | Collaborator |
---|---|
Kenya Medical Research Institute | Kanazawa University |
Kenya,
Ávila S, Kugo M, Silveira Hornung P, Apea-Bah FB, Songok EM, Beta T. Carica papaya seed enhances phytochemicals and functional properties in cornmeal porridges. Food Chem. 2020 Apr 15;323:126808. doi: 10.1016/j.foodchem.2020.126808. [Epub ahead of print] — View Citation
Kermanshai R, McCarry BE, Rosenfeld J, Summers PS, Weretilnyk EA, Sorger GJ. Benzyl isothiocyanate is the chief or sole anthelmintic in papaya seed extracts. Phytochemistry. 2001 Jun;57(3):427-35. — View Citation
Kugo M, Keter L, Maiyo A, Kinyua J, Ndemwa P, Maina G, Otieno P, Songok EM. Fortification of Carica papaya fruit seeds to school meal snacks may aid Africa mass deworming programs: a preliminary survey. BMC Complement Altern Med. 2018 Dec 7;18(1):327. doi: 10.1186/s12906-018-2379-2. — View Citation
Okeniyi JA, Ogunlesi TA, Oyelami OA, Adeyemi LA. Effectiveness of dried Carica papaya seeds against human intestinal parasitosis: a pilot study. J Med Food. 2007 Mar;10(1):194-6. — View Citation
Sapaat A, Satrija F, Mahsol HH, Ahmad AH. Anthelmintic activity of papaya seeds on Hymenolepis diminuta infections in rats. Trop Biomed. 2012 Dec;29(4):508-12. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Parasite egg count | Parasitic eggs in a stool sample will be counted at the end of the intervention, using the Katz thick smear technique, and recorded as eggs per gram of faeces (EPG) | 90 days after randomization | |
Secondary | Body Mass Index for age | Height, Weight and age will be collected. BMI will be calculated using WHO guidelines. | 90 days after intervention | |
Secondary | Class attendance | The class register used by the class teacher to record daily student attendance will be used to gather information on attendance, enrollment, and retention of students. | 90 days after randomization | |
Secondary | Haemoglobin levels | Blood sample will be taken for hemoglobin amounts at start and end of intervention | 90 days after randomization | |
Secondary | Number of children with Schistosoma mansoni | Number of children with Schistosoma mansoni will be recorded at start and end of intervention | 90 days after randomization |
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