[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05553743":3,"trial-entities:NCT05553743":104,"trial-summary:NCT05553743":107},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":24,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":28,"interventions":31,"primary_outcomes":44,"secondary_outcomes":53,"sex":61,"minimum_age":62,"maximum_age":26,"healthy_volunteers":63,"eligibility_criteria":64,"std_ages":71,"locations":74,"central_contacts":87,"overall_officials":95,"references":98,"see_also_links":103},"NCT05553743","130658","Researchers At UC San Diego Are Learning About the Benefits of Human Milk and How It Influences Infant and Child Health","The UCSD Human Milk Biorepository","RECRUITING","2040-03","2024-12","2025-01-31","2014-03-27","University of California, San Diego","OTHER",false,"The purpose of the UCSD Human Milk Biorepository is to establish and maintain a repository of breast milk samples that can be used to learn more about how breast milk influences infant and child health.","Participants in this study will participate in the following:\n\n1. Provide a milk sample:\n\n   If participants agree, the investigators will ask participants to express 50ml (about 2 ounces) of milk. The investigators will take as much as participants wish to donate, or as little as one teaspoon.\n2. Answer questions about participant's health:\n\n   Future researchers may need to know if participants have any health problems, or about any treatments participants have had while breastfeeding. The investigators will ask participants for some contact information, health habits, and family's health history.\n3. Fill out online questionnaires about participant's eating habits and mood:\n\n   The investigators will ask the participant to answer an online questionnaire about how often participants eat certain foods.\n\n   The investigators will also have the participant answer some questions about the participant's mood and how the participant has been feeling recently. The questionnaires can be completed on a tablet at the visit, or the investigators may send an email with a link to fill it out online. These questionnaires take about 30 minutes altogether.\n4. The investigators will store the participant's sample and information in the Human Milk Biorepository:\n\n   The investigators will keep the participant's milk and health information in the Human Milk Biorepository. There is no limit on the length of time we will keep the milk and information. The investigators will keep them as long as they are useful, unless the participant asks to remove them.\n5. The investigators will let researchers use the stored materials for approved research studies:\n\n   Researchers can apply to study the samples and information stored in the Human Milk Biorepository.\n6. If the participant agrees, the investigators may contact the participant with information about other research studies.",[19,20,21,22,23],"Breastfeeding","COVID-19 Infection","COVID-19 Vaccine","Remdesivir","Antibiotics",[19,20,21,22,23],"OBSERVATIONAL",null,[],{"count":29,"type":30},5000,"ESTIMATED",[32,38],{"type":33,"name":34,"description":35,"armGroupLabels":36},"BIOLOGICAL","COVID-19 Exposure","Have been or may have been exposed to COVID-19.",[37],"Sub-study 100: COVID-19 Exposure",{"type":39,"name":40,"description":41,"armGroupLabels":42},"DRUG","Antibiotic","Have or have not been prescribed one of several commonly used antibiotics including azithromycin, amoxicillin and clavulanic acid, amoxicillin, or nitrofurantoin.",[43],"Sub-study 101: Antibiotic Exposure",[45,49],{"measure":46,"description":47,"timeFrame":48},"Human Milk Repository","Establish a human milk repository at UCSD","1 year",{"measure":50,"description":51,"timeFrame":52},"Develop, maintain and manage the Repository","Develop, maintain and manage the Repository as a resource for investigators to conduct research on the health characteristics and benefits of human breast milk.","Through study completion, an average of 2 years",[54,56,58],{"measure":37,"description":55,"timeFrame":52},"Develop, maintain and manage collection of other specimens for evidence of exposure to SARS-CoV-2, the virus responsible for COVID-19 disease.",{"measure":43,"description":57,"timeFrame":52},"Determine the pharmacokinetics of commonly used antibiotics (e.g., azithromycin, amoxicillin and clavulanic acid, amoxicillin or nitrofurantoin) in human milk samples.",{"measure":59,"description":60,"timeFrame":52},"Sub-study 102: P50 MPRINT Admin Supplement","Expand enrollment in the UC San Diego human milk research biorepository to include 300 new participants who will provide milk samples paired with maternal and infant blood, stool, skin swabs, and maternal saliva.","FEMALE","18 Years",true,{"inclusion":65,"exclusion":68,"raw_text":70},[66,19,67],"Women who are 18 years old or older","Producing sufficient breast milk to donate an excess to the Biorepository",[69],"Women under 18 years old","Inclusion Criteria:\n\n* Women who are 18 years old or older\n* Breastfeeding\n* Producing sufficient breast milk to donate an excess to the Biorepository\n\nExclusion Criteria:\n\n* Women under 18 years old",[72,73],"ADULT","OLDER_ADULT",[75],{"facility":13,"status":8,"city":76,"state":77,"zip":78,"country":79,"contacts":80,"geoPoint":84},"San Diego","California","92093","United States",[81],{"name":82,"role":83},"Christina Chambers, PhD, MPH","CONTACT",{"lat":85,"lon":86},32.71571,-117.16472,[88,91],{"name":82,"role":83,"phone":89,"email":90},"858-246-1793","chchambers@ucsd.edu",{"name":92,"role":83,"phone":93,"email":94},"Kerri Bertrand","858-246-1713","kdutcher@ucsd.edu",[96],{"name":82,"affiliation":13,"role":97},"PRINCIPAL_INVESTIGATOR",[99],{"pmid":100,"type":101,"citation":102},"36454186","DERIVED","Bertrand K, Kelly A, Chambers CD. The Prevalence of Nonserious Events in a Cohort of Breastfed Infants. Breastfeed Med. 2023 Jan;18(1):43-47. doi: 10.1089\u002Fbfm.2022.0245. Epub 2022 Nov 28.",[],{"nct_id":4,"conditions":105,"biomarkers":106},[20],[],{"nct_id":4,"found":63,"summary":108,"prompt_version":118},{"design":109,"status":110,"heading":111,"summary":112,"follow_up":113,"word_count":114,"commitments":115,"compensation":116,"drugs_mentioned":117},"This is an observational study with a planned enrollment of 5000 participants. It is designed to collect and store breast milk samples and health information.","completed","Learning About Human Milk and Infant Health","Researchers at UC San Diego are creating a collection of breast milk samples to understand how human milk affects the health of babies and children. This observational study is open to breastfeeding women aged 18 or older who can donate extra milk. They are collecting milk samples and information about participants' health, including any exposure to COVID-19, COVID-19 vaccination, or use of medications like Remdesivir or common antibiotics (azithromycin, amoxicillin and clavulanic acid, amoxicillin, or nitrofurantoin). The goal is to build and manage this milk collection over an average of two years to support future research.","Your milk sample and information will be stored in the Human Milk Biorepository, which will be maintained and managed through study completion, an average of two years.",96,"You would provide a milk sample (as little as one teaspoon up to 50ml), answer questions about your health and medical history, and complete online questionnaires about your eating habits and mood (about 30 minutes).","Not stated in the trial record.",[40],"v2"]