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Schistosomiasis in Senegal

Primary Purpose

Schistosomiasis

Status
Active
Phase
Not Applicable
Locations
Senegal
Study Type
Interventional
Intervention
Bottom-up intervention
Sponsored by
University of Notre Dame
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Schistosomiasis

Eligibility Criteria

5 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • School age children

Exclusion Criteria:

  • Non-school age children

Sites / Locations

  • Espoir Pour La Santé (EPLS)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Experimental

Arm Label

Status quo

Low risk

No agrochemicals

Arm Description

Status quo pesticide use

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

Villages that eliminate agrochemicals

Outcomes

Primary Outcome Measures

Schistosomiasis reinfection rate
Schistosomiasis reinfection rate

Secondary Outcome Measures

Crop yields
Crop yields

Full Information

First Posted
June 12, 2017
Last Updated
March 21, 2023
Sponsor
University of Notre Dame
Collaborators
Biomedical Research Center EPLS
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1. Study Identification

Unique Protocol Identification Number
NCT03187366
Brief Title
Schistosomiasis in Senegal
Official Title
EID: Using Community Ecology Theory to Predict the Effects of Agricultural Expansion and Intensification on Infections of Humans: Implications for Sustainable Agriculture
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 2, 2017 (Actual)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
September 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Notre Dame
Collaborators
Biomedical Research Center EPLS

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schistosomiasis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1477 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Status quo
Arm Type
No Intervention
Arm Description
Status quo pesticide use
Arm Title
Low risk
Arm Type
Active Comparator
Arm Description
Villages shifted to low risk pesticides that don't kill prawns
Arm Title
No agrochemicals
Arm Type
Experimental
Arm Description
Villages that eliminate agrochemicals
Intervention Type
Other
Intervention Name(s)
Bottom-up intervention
Other Intervention Name(s)
Top-down intervention
Intervention Description
Some interventions are bottom-up, where we manipulate the resources of snails and some are top-down, where we manipulate the predators of snails.
Primary Outcome Measure Information:
Title
Schistosomiasis reinfection rate
Description
Schistosomiasis reinfection rate
Time Frame
One year
Secondary Outcome Measure Information:
Title
Crop yields
Description
Crop yields
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: School age children Exclusion Criteria: Non-school age children
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason R Rohr, PhD
Organizational Affiliation
University of South Florida, Department of Integrative Biology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Espoir Pour La Santé (EPLS)
City
Saint-Louis
Country
Senegal

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Schistosomiasis in Senegal

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