Clinical Evaluation of Ujiplus® Against Schistosoma Mansoni

July 11, 2022 updated by: Elijah M. Songok, Kenya Medical Research Institute

Clinical Evaluation of Ujiplus®, a Porridge Snack With Deworming Properties for Activity Against Schistosoma Mansoni

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Interventional

Enrollment (Actual)

400

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Mbita, Kenya, 40305
        • Mbita

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 8 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Consenting parents and guardians

Exclusion Criteria:

  • Children with known allergy to papaya fruit products

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Ujiplus® porridge
Arm receiving porridge fortified with dried papaya seeds (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.
ACTIVE_COMPARATOR: Praziquantel 400mg
Arm receiving the approved Praziquantel treatment of 400mg once with plain porridge daily (without papaya seeds)
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 Names:
  • Biltricide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parasite egg count
Time Frame: 90 days after randomization
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body Mass Index for age
Time Frame: 90 days after intervention
Height, Weight and age will be collected. BMI will be calculated using WHO guidelines.
90 days after intervention
Class attendance
Time Frame: 90 days after randomization
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
Haemoglobin levels
Time Frame: 90 days after randomization
Blood sample will be taken for hemoglobin amounts at start and end of intervention
90 days after randomization
Number of children with Schistosoma mansoni
Time Frame: 90 days after randomization
Number of children with Schistosoma mansoni will be recorded at start and end of intervention
90 days after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 6, 2021

Primary Completion (ACTUAL)

March 30, 2022

Study Completion (ACTUAL)

March 30, 2022

Study Registration Dates

First Submitted

December 18, 2020

First Submitted That Met QC Criteria

December 18, 2020

First Posted (ACTUAL)

December 22, 2020

Study Record Updates

Last Update Posted (ACTUAL)

July 12, 2022

Last Update Submitted That Met QC Criteria

July 11, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • SSC2580/2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All IPD that underlie results in a publication

IPD Sharing Time Frame

Starting September 2021

IPD Sharing Access Criteria

Publication

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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