RecruitingNCT07195006

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)


Sponsor

University of Zimbabwe

Enrollment

368 participants

Start Date

Jan 27, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

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. Primary outcomes 1. Infant malnutrition and recovery. 2. Gut dysfunction (gut inflammation, leaky gut, malabsorption, dysbiosis) 3. 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. Definition of malnutrition outcomes to be assessed in babies born to malnourished women, is a mid- upper arm circumference (MUAC) \<23cm; * MUAC for age: Malnourished defined as those below -2 standard (SD) of the World Health Organisation (WHO) reference * Weight-for-age: Underweight defined as those below -2SD WHO reference * Weight-for-height: Wasted defined as those below -2SD WHO reference * Height-for-age: Stunted defined as those below -2SD WHO reference * Z-scores (as they are i.e. a continuous variable, taking age of infants into account) * A composite variable, any of malnourished, underweight, wasted or stunted.


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria12

  • 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.
  • 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 Criteria2

  • 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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Interventions

OTHERMalnutrition in pregnancy as exposure

MUAC ≤23 cm in pregnancy at least 20 weeks gestational age

OTHERPoor 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. WASH Index score ranges; 1.Basic services (76-100%), 2.Semi-basic services (51-75%) 3.Poor services (26-50%) 4.No services (0-25%)


Locations(1)

University of Zimbabwe

Harare, Zimbabwe

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NCT07195006


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