Ignite Creation Date:
2025-12-24 @ 4:20 PM
Ignite Modification Date:
2026-01-29 @ 1:39 AM
Study NCT ID:
NCT03187366
Status:
UNKNOWN
Last Update Posted:
2023-03-22
First Post:
2017-06-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Schistosomiasis in Senegal
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-08-28', 'releaseDate': '2025-08-12'}, {'resetDate': '2025-09-18', 'releaseDate': '2025-08-29'}], 'estimatedResultsFirstSubmitDate': '2025-08-12'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D012552', 'term': 'Schistosomiasis'}], 'ancestors': [{'id': 'D014201', 'term': 'Trematode Infections'}, {'id': 'D006373', 'term': 'Helminthiasis'}, {'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1477}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-21', 'studyFirstSubmitDate': '2017-06-12', 'studyFirstSubmitQcDate': '2017-06-12', 'lastUpdatePostDateStruct': {'date': '2023-03-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Schistosomiasis reinfection rate', 'timeFrame': 'One year', 'description': 'Schistosomiasis reinfection rate'}], 'secondaryOutcomes': [{'measure': 'Crop yields', 'timeFrame': 'One year', 'description': 'Crop yields'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Schistosomiasis']}, 'referencesModule': {'references': [{'pmid': '37438520', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '5 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* School age children\n\nExclusion Criteria:\n\n* Non-school age children'}, 'identificationModule': {'nctId': 'NCT03187366', 'briefTitle': 'Schistosomiasis in Senegal', 'organization': {'class': 'OTHER', 'fullName': 'University of Notre Dame'}, 'officialTitle': 'EID: Using Community Ecology Theory to Predict the Effects of Agricultural Expansion and Intensification on Infections of Humans: Implications for Sustainable Agriculture', 'orgStudyIdInfo': {'id': 'R01TW010286', 'link': 'https://reporter.nih.gov/quickSearch/R01TW010286', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Status quo', 'description': 'Status quo pesticide use'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Low risk', 'description': "Villages shifted to low risk pesticides that don't kill prawns", 'interventionNames': ['Other: Bottom-up intervention']}, {'type': 'EXPERIMENTAL', 'label': 'No agrochemicals', 'description': 'Villages that eliminate agrochemicals', 'interventionNames': ['Other: Bottom-up intervention']}], 'interventions': [{'name': 'Bottom-up intervention', 'type': 'OTHER', 'otherNames': ['Top-down 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.', 'armGroupLabels': ['Low risk', 'No agrochemicals']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Saint-Louis', 'country': 'Senegal', 'facility': 'Espoir Pour La Santé (EPLS)', 'geoPoint': {'lat': 16.01793, 'lon': -16.48962}}], 'overallOfficials': [{'name': 'Jason R Rohr, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of South Florida, Department of Integrative Biology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Notre Dame', 'class': 'OTHER'}, 'collaborators': [{'name': 'Biomedical Research Center EPLS', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-08-12', 'type': 'RELEASE'}, {'date': '2025-08-28', 'type': 'RESET'}, {'date': '2025-08-29', 'type': 'RELEASE'}, {'date': '2025-09-18', 'type': 'RESET'}], 'unpostedResponsibleParty': 'University of Notre Dame'}}}}