Early Life Malnutrition, Environmental Enteric Dysfunction and Microbiome Trajectories

NCT07195006 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 368

Last updated 2025-09-26

No results posted yet for this study

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.

Conditions

  • 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

Interventions

OTHER

Malnutrition in pregnancy as exposure

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

OTHER

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. 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%)

Sponsors & Collaborators

  • University of Bern

    collaborator OTHER
  • Insel Gruppe AG, University Hospital Bern

    collaborator OTHER
  • LMU Klinikum

    collaborator OTHER
  • University of Zimbabwe

    lead OTHER

Principal Investigators

  • Kerina Duri, Phd · University of Zimbabwe

  • Exnevia Gomo, PhD · University of Zimbabwe

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-01-27
Primary Completion
2029-12-31
Completion
2032-12-31

Countries

  • Zimbabwe

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07195006 on ClinicalTrials.gov