In rural Zimbabwe, a clinical trial will test whether a common antibiotic called cotrimoxazole can prevent stunting and low birth weight in babies. Stunting—being too short for one’s age—affects millions of children worldwide, begins before birth, and raises the risk of death and lifelong poor health. Standard nutrition interventions, such as supplements and education, have only modest effects. This research addresses a specific gap: whether chronic inflammation, driven by infections and gut dysfunction, is a hidden cause of poor fetal and infant growth. If so, cotrimoxazole, which fights bacteria and reduces inflammation, could break that link. The trial works in two phases. Pregnant women receive a lipid-based nutrient supplement and are randomised to cotrimoxazole or placebo; the key measure is birth weight. After birth, breastfeeding women continue the supplement, and their infants are randomised to cotrimoxazole or placebo; the key measure is height at six months. The researchers will also analyse biological samples to understand how the drug works. If cotrimoxazole improves birth weight and postnatal growth, it could offer a low-cost, scalable addition to nutrition programmes in regions where stunting is entrenched. The findings would also clarify whether targeting inflammation early in life is a viable strategy—a mechanistic insight that could guide future interventions beyond this single drug.
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The goal of this proposal is to evaluate the impact of cotrimoxazole, integrated with a package of nutrition interventions early in the lifecourse, on healthy birth and growth in rural Zimbabwe. Stunting is highly prevalent, begins in utero and causes increased mortality and reduced long-term productivity. Current nutrition-specific interventions have only a marginal impact. New approaches targeting mechanistic pathways early in the life-cycle are needed. We will use cotrimoxazole to test the hy pothesis that inflammation is a common mechanism underlying preterm birth, intrauterine growth restriction and postnatal stunting. We hypothesize that inflammation is driven predominantly by clinical and subclinical infections, abnormal micobiota composition and environmental enteric dysfunction, all of which will be impacted by cotrimoxazole. The specific questions are: 1) Does antenatal cotrimoxazole improve fetal growth and reduce prematurity? 2) Does postnatal cotrimoxazole improve li near growth? 3) Through what mechanistic pathways does cotrimoxazole operate? We will conduct a randomised clinical trial of cotrimoxazole, integrated with a package of evidence-based nutrition interventions, in two phases. First, women will receive a lipid-based nutrient supplement (LiNS) and nutrition education during pregnancy and will be randomised to daily cotrimoxazole or placebo, with a primary outcome of birth weight. Second, breastfeeding women will continue to receive LiNS and nut rition education; their infants will be randomised to daily cotrimoxazole or placebo, with a primary outcome of height-for-age Z-score at 6 months. Finally, we will investigate the impact of cotrimoxazole on underlying biological pathways to better understand its mechanism of action.
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