Clinical Evaluation of Ujiplus® Against Schistosoma Mansoni

NCT04679831 | Completed Phase 2 DMC

• 1 other identifier: SSC2580/2
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Schistosoma Mansoni

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Body Mass Index for age

  90 days after intervention

• Class attendance

  90 days after randomization

• Haemoglobin levels

  90 days after randomization

• Number of children with Schistosoma mansoni

  90 days after randomization

Study Arms (2)

Ujiplus® porridge

EXPERIMENTAL

Arm receiving porridge fortified with dried papaya seeds (Ujiplus)

Dietary Supplement: Ujiplus®

Praziquantel 400mg

ACTIVE COMPARATOR

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

Drug: Praziquantel 400mg

Interventions

Ujiplus® 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.

Ujiplus® porridge

Praziquantel 400mg 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,

Also known as: Biltricide

Praziquantel 400mg

Eligibility Criteria

• Age: 6 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Consenting parents and guardians

You may not qualify if:

• Children with known allergy to papaya fruit products

Sponsors & Collaborators

• Kenya Medical Research Institute: lead
• Kanazawa University: collaborator

Study Sites (1)

Mbita

Mbita, 40305, Kenya

Location

Related Publications (5)

• 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.

  PMID: 32335458 BACKGROUND

• 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.

  PMID: 30526582 BACKGROUND

• 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.

  PMID: 17472487 BACKGROUND

• 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.

  PMID: 11393524 BACKGROUND

• 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.

  PMID: 23202594 BACKGROUND

MeSH Terms

Conditions

Schistosomiasis

Interventions

Praziquantel

Condition Hierarchy (Ancestors)

Trematode Infections; Helminthiasis; Parasitic Diseases; Infections; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Elijah M Songok, PhD

  Kenya Medical Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Proffesor

Model Details: 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.

Study Record Dates

• First Submitted: December 18, 2020
• First Posted: December 22, 2020
• Study Start: May 6, 2021
• Primary Completion: March 30, 2022
• Study Completion: March 30, 2022
• Last Updated: July 12, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Starting September 2021
• Access Criteria: Publication

Locations

KE (1)