The Safe Start Trial: A Cluster Randomized Controlled Trial for the Effect of an Infant Hygiene Intervention on Enteric Infections and Diarrhoea in Low-Income Informal Settlements of Kisumu, Kenya

Abstract

Background Symptomatic and asymptomatic enteric infections in early childhood are associated with negative effects on childhood growth and development, especially in low and middle-income countries, and food may be an important transmission route. Although basic food hygiene practices might reduce exposure to faecal pathogens and resulting infections, there have been few rigorous interventions studies to assess this, and no studies in poor urban settings where risks are plausibly very high. The aim of this study is to evaluate the impact of a novel infant food hygiene intervention on infant enteric infections and diarrhoea in peri-urban settlements of Kisumu, Kenya. Methods This is a cluster randomized control trial with 50 clusters, representing the catchment areas of community health volunteers (CHVs), randomly assigned to intervention or control, and a total of 750 infants recruited on a rolling basis at 22 weeks of age and then followed for 15 weeks. The intervention targeted four caregiver behaviours related to food hygiene: 1) hand washing with soap before infant food preparation and feeding; 2) bringing all food to the boil before feeding, including when reserving; 3) storing all food in sealed containers; and, 4) using specific utensils for feeding which are kept separate and clean. The primary outcome of interest is the prevalence of one or more of 23 pre-specified enteric infections, determined using quantitative real-time polymerase chain reaction for enteric pathogen gene targets. Infant food samples were collected at 33 weeks, and faecal indicator bacteria (Enterococcus) isolated and enumerated to assess the impact of the intervention on food contamination. Discussion To our knowledge this is the first randomized controlled trial to assess the effect of an infant food hygiene intervention on enteric infections in a high burden, poor urban setting. Our trial responds to growing evidence that food may be a key pathway for early childhood enteric infection and disease and that basic food hygiene behaviours may be able to mitigate these risks. The study seeks to provide new evidence as to whether a locally appropriate infant food hygiene intervention delivered through the local health extension system can improve the health of young children.

Protocol for the PATHOME study: a cohort study on urban societal development and the ecology of enteric disease transmission among infants, domestic animals and the environment

“…The study is situated in low-income and middle-income communities in two different Kenyan cities, Nairobi (population 4.4 million persons) and Kisumu (population~610 000 in 2019) where our team has performed prior health research 38–51. The prevalence of diarrhoea in children in Kenya is high (~15%) with most cases occurring in children under 3 years of age, and roughly 25% of children are severely stunted 52.…”

“…Over the 14-day enrolment window, households participate in a series of data collection activities as shown in figure 3. Between study enrolment and onset of data collection, the field team provides the caregiver a pack of disposable diapers sized by the infant’s weight, and asks her to use them immediately and for the duration of the 14-day study, providing any containing infant faeces to the study team 46. On day 1, our field staff collect the initial baseline diaper with infant faeces and conduct a survey on socioeconomic conditions, behaviours and health in the household.…”

Bacteroides Microbial Source Tracking Markers Perform Poorly in Predicting Enterobacteriaceae and Enteric Pathogen Contamination of Cow Milk Products and Milk-Containing Infant Food

“…Sample collection was completed as part of the joint Safe-Start and Market to Mouth studies in informal settlements of Kisumu, Kenya, from 2018 to 2019, as described elsewhere (Mumma et al, 2019;Hoffmann et al, 2020). The Safe-Start study was approved by the committees from the Great Lakes University of Kisumu (Ref.…”

“…14695), and the University of Iowa (IRB ID 201804204). Briefly, Safe-Start enumerators performed household visits among caregivers enrolled in the Safe-Start clinical trial at an intermediate point of the trial to observe their food preparation, feeding, and storage behaviors for infant food (Mumma et al, 2019). If caregivers intended to use milk, Market to Mouth enumerators arranged to accompany caregivers to the market to purchase milk for infant food.…”