NCT07195006 Early Life Malnutrition, Environmental Enteric Dysfunction and Microbiome Trajectories
| NCT ID | NCT07195006 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Zimbabwe |
| Condition | Malnutrition Pregnancy |
| Study Type | OBSERVATIONAL |
| Enrollment | 368 participants |
| Start Date | 2025-01-27 |
| Primary Completion | 2029-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 368 participants in total. It began in 2025-01-27 with a primary completion date of 2029-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria for Cases: * 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 Inclusion criteria for Controls * 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 Criteria * 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.
Contact & Investigator
Kerina Duri, Phd
PRINCIPAL INVESTIGATOR
University of Zimbabwe
Frequently Asked Questions
Who can join the NCT07195006 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Malnutrition Pregnancy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07195006 currently recruiting?
Yes, NCT07195006 is actively recruiting participants. Contact the research team at kerina.duri@gmail.com for enrollment information.
Where is the NCT07195006 trial being conducted?
This trial is being conducted at Harare, Zimbabwe.
Who is sponsoring the NCT07195006 clinical trial?
NCT07195006 is sponsored by University of Zimbabwe. The principal investigator is Kerina Duri, Phd at University of Zimbabwe. The trial plans to enroll 368 participants.