Ignite Creation Date:
2025-12-25 @ 4:57 AM
Ignite Modification Date:
2026-02-28 @ 7:28 AM
Study NCT ID:
NCT02764918
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-03-30
First Post:
2016-05-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cryptosporidiosis and Enteropathogens in Bangladesh
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003457', 'term': 'Cryptosporidiosis'}], 'ancestors': [{'id': 'D007411', 'term': 'Intestinal Diseases, Parasitic'}, {'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011529', 'term': 'Protozoan Infections, Animal'}, {'id': 'D010273', 'term': 'Parasitic Diseases, Animal'}, {'id': 'D003048', 'term': 'Coccidiosis'}, {'id': 'D011528', 'term': 'Protozoan Infections'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D000820', 'term': 'Animal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2029-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-25', 'studyFirstSubmitDate': '2016-05-02', 'studyFirstSubmitQcDate': '2016-05-04', 'lastUpdatePostDateStruct': {'date': '2025-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional characterization of anti-Cryptosporidium antibodies associated with protection', 'timeFrame': 'Birth until 4 years', 'description': 'Measure antibody isotype and subclass, mucosal (stool) vs systemic (plasma), complement fixation and opsonophagocytosis using bead-based multiplex immunoassays.'}], 'secondaryOutcomes': [{'measure': 'In depth characterization of Cryptosporidium antigens recognized by the child humoral immune response', 'timeFrame': 'Birth until 4 years.', 'description': 'Utilize this longitudinal study of children and a Cryptosporidium protein microarray to probe plasma for the breadth of antigens recognized as well as the specific antigens to which children respond as they develop protective immunity.'}, {'measure': 'Polymerase chain reaction (PCR) testing for diarrheal pathogens during acute infection', 'timeFrame': 'Birth to 4 years old', 'description': "To be conducted on children's acute and convalescent stool during diarrheal episodes."}, {'measure': 'Determine the role of circulating T follicular helper (cTfh) cells in induction of antibody response', 'timeFrame': 'Through collection of blood specimens on day 0, 14 and 28 during acute infection.', 'description': 'Use Activation Induced Marker (AIM) assays to test parasite infection-dependent changes in the activation, frequency, and immunophenotype of circulating Tfh cells.'}, {'measure': 'Determination of maternal humoral response and impact on child infection/immunity', 'timeFrame': 'On enrollment (all) and 4 months (breast milk only).', 'description': 'Collect mother blood, stool and breast milk on enrollment. Collect second breast milk at 4 months.'}, {'measure': 'Surveillance polymerase chain reaction (PCR) testing for diarrheal pathogens', 'timeFrame': 'Birth until 4 years.', 'description': 'To be conducted on child non diarrheal stool collected twice monthly.'}, {'measure': 'Determine child anthropometric measures', 'timeFrame': 'Every 6 months until 4 years', 'description': 'Collect height, weight, mid-upper arm circumference.'}, {'measure': 'Socioeconomic status questionnaire', 'timeFrame': 'At enrollment', 'description': 'To be conducted on mothers.'}, {'measure': 'Household sanitation questionnaire', 'timeFrame': 'At enrollment', 'description': 'To be conducted on mothers.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cryptosporidiosis']}, 'referencesModule': {'references': [{'pmid': '29514308', 'type': 'BACKGROUND', 'citation': 'Gilchrist CA, Cotton JA, Burkey C, Arju T, Gilmartin A, Lin Y, Ahmed E, Steiner K, Alam M, Ahmed S, Robinson G, Zaman SU, Kabir M, Sanders M, Chalmers RM, Ahmed T, Ma JZ, Haque R, Faruque ASG, Berriman M, Petri WA. Genetic Diversity of Cryptosporidium hominis in a Bangladeshi Community as Revealed by Whole-Genome Sequencing. J Infect Dis. 2018 Jun 20;218(2):259-264. doi: 10.1093/infdis/jiy121.'}, {'pmid': '29897482', 'type': 'BACKGROUND', 'citation': 'Steiner KL, Ahmed S, Gilchrist CA, Burkey C, Cook H, Ma JZ, Korpe PS, Ahmed E, Alam M, Kabir M, Tofail F, Ahmed T, Haque R, Petri WA Jr, Faruque ASG. Species of Cryptosporidia Causing Subclinical Infection Associated With Growth Faltering in Rural and Urban Bangladesh: A Birth Cohort Study. Clin Infect Dis. 2018 Oct 15;67(9):1347-1355. doi: 10.1093/cid/ciy310.'}, {'pmid': '31131855', 'type': 'BACKGROUND', 'citation': 'Steiner KL, Kabir M, Priest JW, Hossain B, Gilchrist CA, Cook H, Ma JZ, Korpe PS, Ahmed T, Faruque ASG, Haque R, Petri WA. Fecal Immunoglobulin A Against a Sporozoite Antigen at 12 Months Is Associated With Delayed Time to Subsequent Cryptosporidiosis in Urban Bangladesh: A Prospective Cohort Study. Clin Infect Dis. 2020 Jan 2;70(2):323-326. doi: 10.1093/cid/ciz430.'}, {'pmid': '33399861', 'type': 'BACKGROUND', 'citation': 'Donowitz JR, Drew J, Taniuchi M, Platts-Mills JA, Alam M, Ferdous T, Shama T, Islam MO, Kabir M, Nayak U, Haque R, Petri WA. Diarrheal Pathogens Associated With Growth and Neurodevelopment. Clin Infect Dis. 2021 Aug 2;73(3):e683-e691. doi: 10.1093/cid/ciaa1938.'}, {'pmid': '34693912', 'type': 'BACKGROUND', 'citation': 'Donowitz JR, Pu Z, Lin Y, Alam M, Ferdous T, Shama T, Taniuchi M, Islam MO, Kabir M, Nayak U, Faruque ASG, Haque R, Ma JZ, Petri WA Jr. Small Intestine Bacterial Overgrowth in Bangladeshi Infants Is Associated With Growth Stunting in a Longitudinal Cohort. Am J Gastroenterol. 2022 Jan 1;117(1):167-175. doi: 10.14309/ajg.0000000000001535.'}, {'pmid': '34181697', 'type': 'BACKGROUND', 'citation': 'Kabir M, Alam M, Nayak U, Arju T, Hossain B, Tarannum R, Khatun A, White JA, Ma JZ, Haque R, Petri WA Jr, Gilchrist CA. Nonsterile immunity to cryptosporidiosis in infants is associated with mucosal IgA against the sporozoite and protection from malnutrition. PLoS Pathog. 2021 Jun 28;17(6):e1009445. doi: 10.1371/journal.ppat.1009445. eCollection 2021 Jun.'}, {'pmid': '33684930', 'type': 'BACKGROUND', 'citation': 'Carey MA, Medlock GL, Alam M, Kabir M, Uddin MJ, Nayak U, Papin J, Faruque ASG, Haque R, Petri WA, Gilchrist CA. Megasphaera in the Stool Microbiota Is Negatively Associated With Diarrheal Cryptosporidiosis. Clin Infect Dis. 2021 Sep 15;73(6):e1242-e1251. doi: 10.1093/cid/ciab207.'}, {'pmid': '37347553', 'type': 'BACKGROUND', 'citation': 'Gilchrist CA, Campo JJ, Pablo JV, Ma JZ, Teng A, Oberai A, Shandling AD, Alam M, Kabir M, Faruque ASG, Haque R, Petri WA Jr. Specific Cryptosporidium antigens associate with reinfection immunity and protection from cryptosporidiosis. J Clin Invest. 2023 Aug 15;133(16):e166814. doi: 10.1172/JCI166814.'}, {'pmid': '40488529', 'type': 'DERIVED', 'citation': 'Gilchrist CA, Petri WAO, Hossain B, Kabir M, So HH, Moreau GB, Nayak U, Ma JZ, Noor Z, Faruque ASG, Alam M, Haque R, Petri WA Jr. Decrease in Incidence of Diarrhea Due to Cryptosporidium in Bangladeshi Children Is Associated With an Increase in Anti-Cryptosporidium Antibody Avidity. J Infect Dis. 2025 Sep 15;232(3):e362-e371. doi: 10.1093/infdis/jiaf253.'}, {'pmid': '37832036', 'type': 'DERIVED', 'citation': 'Carey M, Arju T, Cotton JA, Alam M, Kabir M, Faruque ASG, Haque R, Petri WA Jr, Gilchrist CA. Genomic Heterogeneity of Cryptosporidium parvum Isolates From Children in Bangladesh: Implications for Parasite Biology and Human Infection. J Infect Dis. 2023 Nov 2;228(9):1292-1298. doi: 10.1093/infdis/jiad257.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to explore the role of anti-parasite antibody in protection of children from the parasitic infection cryptosporidiosis. This work has the promise of identifying immune pathways important for protection from parasitic infections of the gut, and will help with designing a vaccine to prevent this infection estimated to cause, from diarrhea and malnutrition, an overall burden of 12 million disability-adjusted life-years in children.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Days', 'minimumAge': '1 Day', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Mother-child pairs from the Mirpur Neighborhood of Dhaka, Bangladesh', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Mother willing to sign informed consent form.\n* Healthy infant\n* No obvious congenital abnormalities or birth defects.\n* Stable household with no plans to leave the area for the next one year.\n\nExclusion Criteria:\n\n* Parents are not willing to have child's blood drawn.\n* Parents are planning to enroll child into another interventional clinical study during the time period of this trial that could affect the outcomes of this study.\n* Mother not willing to have blood drawn and breast milk extracted.\n* Parents not willing to have field research assistant in home two times per week.\n* History of seizures or other apparent neurologic disorders.\n* Infant has any sibling currently or previously enrolled in this study, including a twin."}, 'identificationModule': {'nctId': 'NCT02764918', 'briefTitle': 'Cryptosporidiosis and Enteropathogens in Bangladesh', 'organization': {'class': 'OTHER', 'fullName': 'University of Virginia'}, 'officialTitle': 'Field Studies of Cryptosporidiosis and Enteropathogens in Bangladesh', 'orgStudyIdInfo': {'id': 'PR13092'}, 'secondaryIdInfos': [{'id': 'R01AI043596', 'link': 'https://reporter.nih.gov/quickSearch/R01AI043596', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Children', 'description': 'n=150'}, {'label': 'Mothers', 'description': 'n=150'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dhaka', 'country': 'Bangladesh', 'facility': 'The International Centre for Diarrhoeal Disease Research, Bangladesh', 'geoPoint': {'lat': 23.7104, 'lon': 90.40744}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Virginia', 'class': 'OTHER'}, 'collaborators': [{'name': 'International Centre for Diarrhoeal Disease Research, Bangladesh', 'class': 'OTHER'}, {'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Division Chief, Infectious Disease', 'investigatorFullName': 'William Petri, MD, PhD', 'investigatorAffiliation': 'University of Virginia'}}}}