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)

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: t
View:

• 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

• 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

Locations
Other Locations
Zimbabwe
University of Zimbabwe
RECRUITING
Harare
Contact Information
Primary
Kerina Duri, PhD
kerina.duri@gmail.com
+2634791631
Backup
Patience Kuona, PhD/MD
patiekuona@gmail.com
+2634791631
Time Frame
Start Date: 2025-01-27
Estimated Completion Date: 2032-12-31
Participants
Target number of participants: 368
Treatments
Group 1; Malnourished pregnant women, improved WASH living conditions
Malnourished, improved WASH: Pregnant women (≥20 weeks) with MUAC ≤23 cm, residing in improved WASH area (Kuwadzana research site, Harare)
Group 2; Normo-nourished pregnant women, improved WASH living conditions
Normo-nourished women, improved WASH living conditions: Pregnant women (≥20 weeks) with MUAC 25-35 cm and Hb ≥11 g/dL, residing in improved WASH area (Kuwadzana research site, Harare)
Group 3; Malnourished pregnant women, poor WASH living conditions
Malnourished women, poor WASH: Pregnant women (≥20 weeks) with MUAC ≤23 cm, residing in poor WASH area (Hopley research site, Harare)
Group 4; Normo-nourished pregnant women, poor WASH living conditions
Normo-nourished women, poor WASH: Pregnant women (≥20 weeks) with MUAC 25-35 cm and Hb ≥11 g/dL, residing in poor WASH area (Hopley research site, Harare)
Related Therapeutic Areas
Sponsors
Leads: University of Zimbabwe
Collaborators: Insel Gruppe AG, University Hospital Bern, LMU Klinikum, University of Bern

This content was sourced from clinicaltrials.gov