**Background:** Childhood undernutrition contributes up to 45% of deaths in children under 5 years globally and impairs long-term health, cognition, and productivity. Undernutrition may begin in utero due to maternal deficiencies and is exacerbated postnatally by poor nutrient intake, infections, and intestinal inflammation (Environmental Enteric Dysfunction, EED). The first 1000 days from conception to 24 months are critical for intervention. Moringa oleifera is a drought-resistant, nutrient-dense tree whose leaves contain high protein (30 g/100 g dried leaf), iron (97.9 mcg/g), vitamin A precursors (17.6–39.6 mg/100 g), B vitamins, calcium, and fiber. A prior systematic review by the authors found that high-dose moringa (14–30 g/day) improved iron and vitamin A status and growth in limited human studies, and 0.5 g/day increased human milk production in one high-quality study. Preclinical studies suggest moringa reduces intestinal inflammation and may influence the microbiome. This protocol describes a pilot trial to investigate moringa's effects on maternal and infant nutritional and intestinal health.
**Methods:** This is a single-blinded cluster randomized controlled pilot trial enrolling 50 mother-infant pairs (100 participants) in Kisumu, Kenya, at Kombewa County Hospital and Chulaimbo Sub-County Hospital. Cluster randomization is at the facility level by coin toss. Eligible participants are women with a single infant born at ≥36 weeks gestation, ≤30 days old at enrollment, intending to exclusively breastfeed for ≥3 months. Exclusion criteria include contraindication to breastfeeding, regular fortified food supplementation, current moringa use, refusal to consume corn porridge with/without moringa after 3 days' attempt, and infants unable to feed orally or with significant congenital disease. The intervention group receives 20 g moringa leaf powder daily (10 g in corn porridge twice daily) for 3 months; the control group receives corn porridge alone twice daily. Blinding of the primary investigator is maintained during data collection and primary outcome analysis (infant growth and 24-hour milk output). Data collection occurs at enrollment and 3-month exit: anthropometrics (weight, height/length, mid-arm circumference), 2 mL capillary blood for hemoglobin (HemoCue Hb201), ferritin, serum retinol, soluble transferrin receptor, C-reactive protein, alpha-1-glycoprotein, and IGF-1; 8 g fecal samples for microbiome and EED markers (maternal fecal calprotectin; infant fecal neopterin, myeloperoxidase, alpha-1-antitrypsin); 24-hour breastmilk output by manual pump; and breastmilk samples for volume, fat and fatty acid profile, vitamin A/carotenoids, and microbiome. Monthly follow-up collects data on confounders (diarrhea, illness, supplementation). Adherence is assessed via pictograph diaries and weighing remaining moringa and corn flour. Sample size was calculated at 16 pairs for 80% power at 95% confidence based on prior milk output data, inflated to 50 pairs to account for attrition (estimated 10%) and smaller effect on growth.
**Key Results:** This is a protocol paper; no results are reported. The study is registered at ClinicalTrials.gov (NCT04587271). Ethical approval was obtained from University of Kentucky IRB and Amref Health Africa Ethics and Scientific Review Committee in Kenya. Enrollment and follow-up are anticipated to take up to 6 months.
**Clinical Implications:** If effective, moringa leaf powder could serve as a practical, low-cost, locally grown intervention to improve maternal and infant nutrition and intestinal health in resource-limited settings. The study addresses critical gaps: effects of moringa on breastmilk composition in humans, impact on infant and maternal intestinal health (microbiome and EED markers), and combined effects on growth and micronutrient status. The open-label design (due to inability to create a placebo matching moringa's color and taste) is a limitation, but blinding of the primary investigator through primary outcome analysis mitigates bias. Results will inform larger trials and potentially guide public health nutrition policy in regions with high undernutrition.