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Active, not recruitingNCT03187366Updated Mar 22, 2023

Schistosomiasis in Senegal

An interventional study of Bottom-up intervention in Schistosomiasis, sponsored by University of Notre Dame. Active, not recruiting at 1 site in Senegal. Open to participants aged 5 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-22.

Sponsored by University of Notre Dame · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
1,477
Allocation
Randomized
Ages
5 Years to 17 Years
Sex
All
01

Study summary

Schistosomiasis is a flatworm transmitted from freshwater snails to humans in the tropics. In addition to this infectious disease, tropical developing countries are faced with malnutrition. We propose to alter pesticide and compost use to reduce schistosomiasis and maintain or even improve crop production.

Read the detailed description

We propose two types of manipulations. Bottom-up manipulations will affect snail resources, whereas top-down manipulations will affect snail predators. For the bottom-up manipulations, we will clear schistosoma infections in school children, then remove the primary habitat for snails, the submerged macrophyte Ceratophyllum demersum (with proper unmanipulated controls), compost it, apply it to crops, and then quantify reinfection rates and crop yields. The second bottom-up manipulation will be to clear schistosoma infections in school children, apply three agrochemical treatments (status quo control, shift to lower risk herbicides, or eliminate herbicides and fertilizers), and then quantify reinfection rates and crop yields. Farmers will be compensated for any loss in yields. For the top-down manipulations, every village will receive prawns that depredate snails. We will clear schistosoma infections in school children, apply three agrochemical treatments (status quo control, shift to lower risk insecticides that don't kill prawns, or eliminate insecticides), and then quantify reinfection rates and crop yields. Farmers will be compensated for any loss in yields.

02

Conditions studied

  • Schistosomiasis

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03

Who can participate

Ages eligible
5 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • School age children

Exclusion criteria

Exclusion Criteria:

  • Non-school age children
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,477 participants (actual)

Study arms

  • No intervention
    Status quo

    Status quo pesticide use

  • Active comparator
    Low risk

    Villages shifted to low risk pesticides that don't kill prawns

    Other: Bottom-up intervention

  • Experimental
    No agrochemicals

    Villages that eliminate agrochemicals

    Other: Bottom-up intervention

Interventions

  • OtherBottom-up intervention

    Some interventions are bottom-up, where we manipulate the resources of snails and some are top-down, where we manipulate the predators of snails.

    Also known as: Top-down intervention

05

What researchers measure

Primary outcomes

  1. Schistosomiasis reinfection rate

    Schistosomiasis reinfection rate

    Time frame: One year

Secondary outcomes

  1. Crop yields

    Crop yields

    Time frame: One year

06

Study locations

1 site
  • Espoir Pour La Santé (EPLS)
    Saint-Louis, Senegal
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03187366
Lead sponsor
University of Notre Dame
Collaborators
Biomedical Research Center EPLS
Responsible party
Sponsor
First posted
Jun 14, 2017
Start date
Jan 2, 2017
Primary completion
Sep 2025 (estimated)
Completion
Sep 2025 (estimated)
Last update
Mar 22, 2023

Study contacts

Jason R Rohr, PhD
principal investigator · University of South Florida, Department of Integrative Biology

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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