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Early Life Malnutrition, Environmental Enteric Dysfunction and Microbiome Trajectories

Recruitingn/aAges 18 Years - anyFemaleUniversity of Zimbabwe
NCT07195006 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 po

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📋 Eligibility rules (as published)
Inclusion Criteria for Cases: * MUAC ≤23 cm in pregnancy * ≥18 years' old * At least 20 weeks' gestational age * Height ≥150 cm * Planning to be staying in the study area for the next 3 years * Willing to participate and comply with all study requirements and procedures. Any 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 Inclusion criteria for Controls * Age, HIV status, gestational age at enrolment, and area residence matched normo-nourished peers with MUAC ≥25 - ≤35 cm * Haemoglobin level of ≥11g/dL * ≥18 years' old * At least 20 weeks' gestational age * Height ≥150 cm * Planning to stay in the study area for the next 3 years Exclusion Criteria * Acute or chronic conditions in mothers interfering with the study according to the judgment of the investigator (HIV infection is not an exclusion criterion) * Presence of severe mental health disorders interfering with study procedures according to the judgment of the investigator.
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What it tests

  • Malnutrition in pregnancy as exposure
  • Poor WASH living conditions as exposure
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Where

1 site
University of Zimbabwe
Harare, Zimbabwe
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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