SchistosomiasisNCT03187366
Schistosomiasis in Senegal
A study testing Bottom-up intervention in people with Schistosomiasis, run by University of Notre Dame at 1 site in Senegal.
Trial 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 more about this study
- Who is it for?
- Ages 5 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Schistosomiasis
- What is being tested?
- Bottom-up intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,477 participants
- Where
- 1 siteSenegal
- Study dates
- 2 Jan 2017to Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- School age children
Who cannot join
- Non-school age children
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EID: Using Community Ecology Theory to Predict the Effects of Agricultural Expansion and Intensification on Infections of Humans: Implications for Sustainable Agriculture
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.
- Conditions
- Schistosomiasis
- Being tested
- Bottom-up intervention
- Medical subject headings
- Schistosomiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bottom-up interventionOther
Also called Top-down 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.
| Study group | Role | What they receive |
|---|---|---|
| Status quo | No intervention | Status quo pesticide use |
| Low risk | Active comparator | Villages shifted to low risk pesticides that don't kill prawns Receives: Other: Bottom-up intervention |
| No agrochemicals | Experimental | Villages that eliminate agrochemicals Receives: Other: Bottom-up intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Schistosomiasis reinfection rate
Schistosomiasis reinfection rate
Measured: One year
Secondary outcomes (1)
Crop yields
Crop yields
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study start2 Jan 2017
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchistosomiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,477 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Notre Dame
- Sponsor type
- University, hospital or other
- Collaborators
- Biomedical Research Center EPLS
- Responsible party
- Sponsor
- Investigators
- Jason R Rohr, PhD, Principal investigator, University of South Florida, Department of Integrative Biology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03187366
- Sponsor's protocol ID
- R01TW010286
- Status last verified
- Mar 2023
- First submitted
- 12 Jun 2017
- Last updated
- 22 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Rohr JR, Sack A, Bakhoum S, Barrett CB, Lopez-Carr D, Chamberlin AJ, Civitello DJ, Diatta C, Doruska MJ, De Leo GA, Haggerty CJE, Jones IJ, Jouanard N, Lund AJ, Ly AT, Ndione RA, Remais JV, Riveau G, Schacht AM, Seck M, Senghor S, Sokolow SH, Wolfe C. A planetary health innovation for disease, food and water challenges in Africa. Nature. 2023 Jul;619(7971):782-787. doi: 10.1038/s41586-023-06313-z. Epub 2023 Jul 12.
PubMed 37438520
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EID: Using Community Ecology Theory to Predict the Effects of Agricultural Expansion and Intensification on Infections of Humans: Implications for Sustainable Agriculture
- ClinicalTrials.gov ID
- NCT03187366
- Acronym / sponsor ID
- R01TW010286
- Conditions
- Schistosomiasis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,477 participants (actual)
- Lead sponsor
- University of Notre DameUniversity, hospital or other
- Collaborators
- Biomedical Research Center EPLS
- Study start
- 2 Jan 2017 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 14 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Status quo | No intervention | –Status quo pesticide use |
| Low risk | Active comparator | Other: Bottom-up interventionVillages shifted to low risk pesticides that don't kill prawns |
| No agrochemicals | Experimental | Other: Bottom-up interventionVillages that eliminate agrochemicals |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- School age children
Key exclusion criteria (1 listed)
- Non-school age children
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bottom-up interventionAlso: Top-down interventionSome interventions are bottom-up, where we manipulate the resources of snails and some are top-down, where we manipulate the predators of snails. | Other | Low risk, No agrochemicals |
Primary outcome
Schistosomiasis reinfection rate
Time frame: One year
Schistosomiasis reinfection rate
1 secondary outcome
Crop yields
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2023.
- Derived from this study: PubMed 37438520Rohr JR, Sack A, Bakhoum S, Barrett CB, Lopez-Carr D, Chamberlin AJ, Civitello DJ, Diatta C, Doruska MJ, De Leo GA, Haggerty CJE, Jones IJ, Jouanard N, Lund AJ, Ly AT, Ndione RA, Remais JV, Riveau G, Schacht AM, Seck M, Senghor S, Sokolow SH, Wolfe C. A planetary health innovation for disease, food and water challenges in Africa. Nature. 2023 Jul;619(7971):782-787. doi: 10.1038/s41586-023-06313-z. Epub 2023 Jul 12.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason R Rohr, PhD principal investigator
University of South Florida, Department of Integrative Biology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bottom-up intervention in people with Schistosomiasis, run by University of Notre Dame at 1 site in Senegal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Senegal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Schistosomiasis reinfection rate (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03187366, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2023.