Clinical Evaluation of Ujiplus® Against Schistosoma Mansoni

NCT ID: NCT04679831

Last Updated: 2022-07-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-06
• Study Completion Date: 2022-03-30

Brief 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.

Conditions

Schistosoma Mansoni

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Ujiplus® porridge

Arm receiving porridge fortified with dried papaya seeds (Ujiplus)

Group Type: EXPERIMENTAL

Ujiplus®

Intervention Type: DIETARY_SUPPLEMENT

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.

Praziquantel 400mg

Arm receiving the approved Praziquantel treatment of 400mg once with plain porridge daily (without papaya seeds)

Group Type: ACTIVE_COMPARATOR

Praziquantel 400mg

Intervention Type: DRUG

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,

Interventions

Ujiplus®

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.

Intervention Type: DIETARY_SUPPLEMENT

Praziquantel 400mg

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,

Intervention Type: DRUG

Other Intervention Names

Biltricide

Eligibility Criteria

Inclusion Criteria

• Consenting parents and guardians

Exclusion Criteria

• Children with known allergy to papaya fruit products

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kanazawa University

OTHER

Sponsor Role: collaborator

Kenya Medical Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Elijah M. Songok

Proffesor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elijah M Songok, PhD

Role: PRINCIPAL_INVESTIGATOR

Kenya Medical Research Institute

Locations

Mbita

Mbita, , Kenya

Countries

Kenya

References

Avila 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 Sep 1;323:126808. doi: 10.1016/j.foodchem.2020.126808. Epub 2020 Apr 15.

Reference Type: BACKGROUND

PMID: 32335458 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30526582 (View on PubMed)

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. doi: 10.1089/jmf.2005.065.

Reference Type: BACKGROUND

PMID: 17472487 (View on PubMed)

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. doi: 10.1016/s0031-9422(01)00077-2.

Reference Type: BACKGROUND

PMID: 11393524 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23202594 (View on PubMed)

Other Identifiers

SSC2580/2

Identifier Type: -

Identifier Source: org_study_id