Actively Recruiting

Age: 18Years +
FEMALE
Healthy Volunteers
NCT07195006

Early Life Malnutrition, Environmental Enteric Dysfunction and Microbiome Trajectories

Led by University of Zimbabwe · Updated on 2025-09-26

368

Participants Needed

1

Research Sites

413 weeks

Total Duration

On this page

Sponsors

U

University of Zimbabwe

Lead Sponsor

U

University of Bern

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Early Life Malnutrition, Environmental Enteric Dysfunction and Microbiome Trajectories

Who Can Participate

Age: 18Years +
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Mid-upper arm circumference (MUAC) less than or equal to 23 cm during pregnancy
  • At least 18 years old
  • Pregnancy at least 20 weeks gestational age
  • Height at least 150 cm
  • Planning to stay in the study area for the next 3 years
  • Willing to participate and follow all study procedures
  • For controls: MUAC between 25 and 35 cm
  • For controls: Hemoglobin level of at least 11 g/dL
  • Controls matched by age, HIV status, gestational age, and residence area
Not Eligible

You will not qualify if you...

  • Acute or chronic conditions interfering with the study as judged by the investigator (HIV infection is not an exclusion)
  • Severe mental health disorders interfering with study procedures as judged by the investigator

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

University of Zimbabwe

Harare, Zimbabwe

Actively Recruiting

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Research Team

K

Kerina Duri, PhD

CONTACT

P

Patience Kuona, PhD/MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

4

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