[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100607934":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":35,"centralContacts":42,"locations":52,"responsibleParty":106,"collaborators":108,"id":115,"slug":116,"hasResults":117,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":121,"eligibilityCriteria":122,"healthyVolunteers":123,"sex":124,"minAge":125,"maxAge":10,"enrollmentInfo":126,"targetDuration":10,"studyType":129,"phases":10,"briefSummary":130,"conditions":131,"keywords":145,"overallStatus":54,"whyStopped":10,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":172},{"fullName":5,"class":6},"University of Zimbabwe","OTHER",[8,14,17,22],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1; Malnourished pregnant women, improved WASH living conditions",null,"Malnourished, improved WASH: Pregnant women (≥20 weeks) with MUAC ≤23 cm, residing in improved WASH area (Kuwadzana research site, Harare)",[13],"Other: Malnutrition in pregnancy as exposure",{"label":15,"type":10,"description":16,"interventionNames":10},"Group 2; Normo-nourished pregnant women, improved WASH living conditions","Normo-nourished women, improved WASH living conditions: Pregnant women (≥20 weeks) with MUAC 25-35 cm and Hb ≥11 g\u002FdL, residing in improved WASH area (Kuwadzana research site, Harare)",{"label":18,"type":10,"description":19,"interventionNames":20},"Group 3; Malnourished pregnant women, poor WASH living conditions","Malnourished women, poor WASH: Pregnant women (≥20 weeks) with MUAC ≤23 cm, residing in poor WASH area (Hopley research site, Harare)",[13,21],"Other: Poor WASH living conditions as exposure",{"label":23,"type":10,"description":24,"interventionNames":25},"Group 4; Normo-nourished pregnant women, poor WASH living conditions","Normo-nourished women, poor WASH: Pregnant women (≥20 weeks) with MUAC 25-35 cm and Hb ≥11 g\u002FdL, residing in poor WASH area (Hopley research site, Harare)",[21],[27,31],{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":10},"Malnutrition in pregnancy as exposure","MUAC ≤23 cm in pregnancy at least 20 weeks gestational age",[9,18],{"type":6,"name":32,"description":33,"armGroupLabels":34,"otherNames":10},"Poor WASH living conditions as exposure","Poor water (source, quality, access, reliability), sanitation (toilet type, cleanliness, number of people using toilet) and personal (hand wash practices) and household hygiene (dumpster availability and emptying frequency) index scores.\n\nWASH Index score ranges; 1.Basic services (76-100%), 2.Semi-basic services (51-75%) 3.Poor services (26-50%) 4.No services (0-25%)",[18,23],[36,39],{"name":37,"affiliation":5,"role":38},"Kerina Duri, Phd","PRINCIPAL_INVESTIGATOR",{"name":40,"affiliation":5,"role":41},"Exnevia Gomo, PhD","STUDY_DIRECTOR",[43,49],{"name":44,"role":45,"phone":46,"phoneExt":47,"email":48},"Kerina Duri, PhD","CONTACT","+2634791631","2428","kerina.duri@gmail.com",{"name":50,"role":45,"phone":46,"phoneExt":10,"email":51},"Patience Kuona, PhD\u002FMD","patiekuona@gmail.com",[53],{"facility":5,"status":54,"city":55,"state":10,"zip":10,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"RECRUITING","Harare","Zimbabwe","ZW",{"type":59,"coordinates":60},"Point",[61,62],31.05337,-17.82772,{"lat":62,"lon":61},[65,66,69,70,72,74,76,78,80,82,84,86,88,90,92,94,96,98,100,102,104],{"name":44,"role":45,"phone":46,"phoneExt":10,"email":48},{"name":67,"role":68,"phone":10,"phoneExt":10,"email":10},"Benjamin Misselwitz, MD","SUB_INVESTIGATOR",{"name":40,"role":68,"phone":10,"phoneExt":10,"email":10},{"name":71,"role":38,"phone":10,"phoneExt":10,"email":10},"Patience Kuona, MD\u002FPhD",{"name":73,"role":68,"phone":10,"phoneExt":10,"email":10},"Mutsa Bwakura- Dangarembizi, MD\u002FPhD",{"name":75,"role":68,"phone":10,"phoneExt":10,"email":10},"Rudo Makunike-Mutasa, MD\u002FPhD",{"name":77,"role":68,"phone":10,"phoneExt":10,"email":10},"Leolin Katsidzira, MD\u002FPhD",{"name":79,"role":68,"phone":10,"phoneExt":10,"email":10},"Munyaradzi P Mapingure, MSc",{"name":81,"role":68,"phone":10,"phoneExt":10,"email":10},"Fiona Makoni, MD",{"name":83,"role":68,"phone":10,"phoneExt":10,"email":10},"Asaph Ziruma, MD\u002FMMED",{"name":85,"role":68,"phone":10,"phoneExt":10,"email":10},"Privilege T Munjoma, MSc",{"name":87,"role":38,"phone":10,"phoneExt":10,"email":10},"Kerina Duri, MSc\u002FPhD",{"name":89,"role":68,"phone":10,"phoneExt":10,"email":10},"Dixon Chibanda, MD\u002FPhD",{"name":91,"role":68,"phone":10,"phoneExt":10,"email":10},"Bahtiyar Yilmaz, PhD",{"name":93,"role":68,"phone":10,"phoneExt":10,"email":10},"Stephanie Ganal-Vonarburg, PhD",{"name":95,"role":68,"phone":10,"phoneExt":10,"email":10},"Christiane Sokollik, MD",{"name":97,"role":68,"phone":10,"phoneExt":10,"email":10},"Andrew Macpherson, MD\u002FPhD",{"name":99,"role":68,"phone":10,"phoneExt":10,"email":10},"Michael Kaess, MD\u002FPhD",{"name":101,"role":68,"phone":10,"phoneExt":10,"email":10},"Siegfried Hapfelmeier, PhD",{"name":103,"role":68,"phone":10,"phoneExt":10,"email":10},"Nabhani Ziad, PhD",{"name":105,"role":68,"phone":10,"phoneExt":10,"email":10},"Arthur J Mazhandu, MSc",{"type":107,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[109,111,113],{"name":110,"class":6},"University of Bern",{"name":112,"class":6},"Insel Gruppe AG, University Hospital Bern",{"name":114,"class":6},"LMU Klinikum","100607934","early-life-malnutrition-environmental-enteric-dysfunction-and-microbiome-trajectories-100607934",false,"NCT07195006","Early Life Malnutrition, Environmental Enteric Dysfunction and Microbiome Trajectories","Early Life Diarrhoea Episode(s), Malnutrition, Environmental Enteric Dysfunction and Microbiome Trajectories From Birth Until 3 Years of Life ; The University of Zimbabwe Birth Cohort Study-2 (UZBCS-2)","UZBCS-2","Inclusion Criteria for Cases:\n\n* MUAC ≤23 cm in pregnancy\n* ≥18 years' old\n* At least 20 weeks' gestational age\n* Height ≥150 cm\n* Planning to be staying in the study area for the next 3 years\n* Willing to participate and comply with all study requirements and procedures.\n\nAny pregnant woman meeting the above eligible criteria regardless of HIV status who meet the above inclusion criteria will be invited to participate in the study\n\nInclusion criteria for Controls\n\n* Age, HIV status, gestational age at enrolment, and area residence matched normo-nourished peers with MUAC ≥25 - ≤35 cm\n* Haemoglobin level of ≥11g\u002FdL\n* ≥18 years' old\n* At least 20 weeks' gestational age\n* Height ≥150 cm\n* Planning to stay in the study area for the next 3 years\n\nExclusion Criteria\n\n* Acute or chronic conditions in mothers interfering with the study according to the judgment of the investigator (HIV infection is not an exclusion criterion)\n* Presence of severe mental health disorders interfering with study procedures according to the judgment of the investigator.",true,"FEMALE","18 Years",{"count":127,"type":128},368,"ESTIMATED","OBSERVATIONAL","Malnutrition in women of reproductive age remains a public health concern in Sub-Saharan Africa (SSA). Malnutrition during pregnancy affects foetal growth with a tendency of the exposed infants to also develop it. The interaction of the mother with the infant shapes the seeding and the trajectory of the infant intestinal microbiota which is crucial for development of a healthy immune system Malnutrition has been associated with intestinal inflammation, intestinal leakage and reduced calorie absorption. Early life malnutrition and environmental enteric dysfunction (EED) immunopathology remains poorly described in the context of mother-infant dyads. This is essential as malnutrition, poor water, sanitation and hygiene (WASH), including the presence of infectious diseases limit the developmental potential of the exposed infants in SSA, including Zimbabwe. In addition, maternal stress and poor mental health may also affect standard hygiene practices, including how a mother cares for her baby, potentially aggravating EED and the risk of the infant being malnourished.\n\nPrimary outcomes\n\n1. Infant malnutrition and recovery.\n2. Gut dysfunction (gut inflammation, leaky gut, malabsorption, dysbiosis)\n3. Diarrhea episodes, defined as any episode of acute diarrhoea (≥3 passages of loose stool within 24 hours as reported by the mother) occurring before the next study visit.\n\nDefinition of malnutrition outcomes to be assessed in babies born to malnourished women, is a mid- upper arm circumference (MUAC) \\\u003C23cm;\n\n* MUAC for age: Malnourished defined as those below -2 standard (SD) of the World Health Organisation (WHO) reference\n* Weight-for-age: Underweight defined as those below -2SD WHO reference\n* Weight-for-height: Wasted defined as those below -2SD WHO reference\n* Height-for-age: Stunted defined as those below -2SD WHO reference\n* Z-scores (as they are i.e. a continuous variable, taking age of infants into account)\n* A composite variable, any of malnourished, underweight, wasted or stunted.",[132,133,134,135,136,137,138,139,140,141,142,143,144],"Malnutrition Pregnancy","Malnutrition in Children","Malnutrition (Calorie)","Environmental Enteric Dysfunction","Gut Dysbiosis","Gut Permeability, Gut Inflammation","Diarrhea Infectious","Maternal Stress","Child Mental Health","Natural Killer Cell Mediated Immunity","Mycotoxin Biomonitoring","Environmental Exposures","Cell-Mediated Immune Deficiency",[146,147,148,149,150,151,152,153,154,155,156,157,158,159,160,161,162],"diarrhoeal episodes","short chain fatty acids receptor agonists","intestinal inflammation, leakage and calory extraction","toxins in drinking water and food","macro- and micronutrient composition of breast milk","human anti-Gal antibodies","mitochondria health and nutrient uptake","endothelial dysfunction and oxidative stress","hormonal mediated molecular signalling mechanisms","interaction of epigenetics & socioeconomic factors","microbiota, pathobionts and oral microbiota","metagenomics","undernutrition and intestinal infections","infant mortality, morbidity within 1st 1000 days of life","low mid upper arm circumference","sleep adequacy in maternal mental health","chronic inflammation","2025-09-18",{"date":165,"type":166},"2025-09-26","ACTUAL",{"date":168,"type":166},"2025-01-27",{"date":170,"type":128},"2032-12-31",{"name":5,"class":6},1]