Actively Recruiting

Age: 18Years +
FEMALE
Healthy Volunteers
ID07195006

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)

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

368

Participants Needed

1

Research Sites

156 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 among women of reproductive age is a significant health issue in Sub-Saharan Africa, including Zimbabwe, affecting both mothers and their infants. This research investigates how maternal malnutrition and poor water, sanitation, and hygiene (WASH) conditions influence infant growth, intestinal microbiota development, immune system maturation, and the risk of intestinal inflammation and malnutrition. The study also considers maternal stress and mental health as factors potentially impacting infant care and health outcomes. The study follows pregnant women from at least 20 weeks gestation, divided into groups based on nutritional status and WASH living conditions. Four groups include malnourished and well-nourished women living in improved or poor WASH environments. Researchers will observe maternal and infant microbiota, breast milk composition, infant gut function, and immune responses from pregnancy through the infant's first three years. The study includes detailed bio-sample collection and analysis at multiple time points to understand the role of environmental and biological factors in infant malnutrition. Participants will undergo regular assessments including maternal and infant stool, blood, and breast milk samples, alongside questionnaires on maternal stress and empowerment. Infant growth and health will be monitored through measures like mid-upper arm circumference, weight, height, and diarrhea episodes. The study aims to track infant intestinal inflammation, permeability, and immune cell populations, with follow-up visits continuing until the child reaches three years old. This comprehensive approach seeks to clarify how maternal and environmental factors contribute to infant malnutrition and development.

CONDITIONS

Brief 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...

  • Pregnant women with mid-upper arm circumference (MUAC) 23 cm or less (cases) or 25-35 cm (controls)
  • At least 18 years old
  • At least 20 weeks gestational age
  • Height 150 cm or taller
  • Planning to stay in the study area for the next 3 years
  • Willing to participate and comply with all study requirements and procedures
  • Controls must have hemoglobin level of 11 g/dL or higher
Not Eligible

You will not qualify if you...

  • Acute or chronic conditions in mothers that interfere with the study as judged by the investigator
  • Severe mental health disorders interfering with study procedures as judged by the investigator
  • HIV infection is not an exclusion criteria

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - From pregnancy (≥20 weeks gestation) until infant is 3 years old

Participants are observed from pregnancy through the infant’s first 3 years of life with repeated assessments of maternal and infant health, microbiota development, intestinal function, and environmental factors.

Multiple visits including assessments during pregnancy, at birth, and at weeks 1, 6, 14, 24, 48, 96, and 144 after delivery; infant visits at birth, 6, 12, 24, and 36 months of age; maternal visits every 6 months until 3 years after delivery

Trial Site Locations

Total: 1 location

1

University of Zimbabwe

Harare, Zimbabwe

Actively Recruiting

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Research Team

K

Kerina Duri, PhD

P

Patience Kuona, PhD/MD

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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Frequently Asked Questions

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Published Research Related To This Trial

The path to longer and healthier lives for all Africans by 2030: the Lancet Commission on the future of health in sub-Saharan Africa.

Irene Akua Agyepong, Nelson Sewankambo, Agnes Binagwaho...

https://pubmed.ncbi.nlm.nih.gov/28917958

Understanding the association between stunting and child development in low- and middle-income countries: Next steps for research and intervention.

Jessica M Perkins, Rockli Kim, Aditi Krishna...

https://pubmed.ncbi.nlm.nih.gov/29028557

Functional characterization of IgA-targeted bacterial taxa from undernourished Malawian children that produce diet-dependent enteropathy.

Andrew L Kau, Joseph D Planer, Jie Liu...

https://pubmed.ncbi.nlm.nih.gov/25717097

Independent and combined effects of improved water, sanitation, and hygiene, and improved complementary feeding, on child stunting and anaemia in rural Zimbabwe: a cluster-randomised trial.

Jean H Humphrey, Mduduzi N N Mbuya, Robert Ntozini...

https://pubmed.ncbi.nlm.nih.gov/30554749