Shedding of enteric pathogens in stool and associated sequelae in children under 5 years of age. Digestive System
Conditions
Interventions
We will revisit both the intervention and control compounds from the MapSan trial to cross-sectionally assess enteric pathogen detection, growth, and seven-day period prevalence of diarrhea in the chi
Sponsors
University of North Carolina at Chapel Hill
Instituto Nacional de Saúde
London School of Hygiene & Tropical Medicine
Eligibility
Sex/Gender
All
Age
29 Days to 60 Months
Inclusion criteria
Inclusion criteria: 1. Child aged 29 days – 60 months old 2. Born and residing in a MapSan trial intervention or control compound; in intervention compounds, child must have been born following the delivery of the sanitation intervention 3. Has continuously resided in the MapSan trial compound for the preceding 6 months 4. Has a parent or guardian who is able to understand and complete the written informed consent process and allow their child to participate
Exclusion criteria
Exclusion criteria: Any caregiver-indicated medical condition or disability that precludes the participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stool-based enteric pathogen detection is assessed by reverse-transcription quantitative polymerase chain reaction (RT-qPCR) using a custom TaqMan Array Card (TAC) to simultaneously detect genetic targets corresponding to 13 bacterial pathogens: (Aeromonas spp.; Campylobacter jejuni/coli; Escherichia coli O157; Clostridioides difficile; enteroaggregative E. coli (EAEC); Shiga toxin-producing E. coli (STEC); enteropathogenic E. coli (EPEC); enterotoxigenic E. coli (ETEC); enteroinvasive E. coli (EIEC)/Shigella spp.; Helicobacter pylori; Plesiomonas shigelloides; Salmonella enterica; Vibrio cholerae) 4 protozoan parasites: (Cryptosporidium spp.; Cyclospora cayetanensis; Entamoeba histolytica; Giardia spp.) and 5 soil transmitted helminths: (Ascaris lumbricoides; Ancylostoma duodenale; Necator americanus; Strongyloides stercolaris; Trichuris trichiura) in child stool collected cross-sectionally one or more days after enrollment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Concurrent with the 22 primary outcome enteric pathogens, stool-based detection of 5 enteric viruses (adenovirus 40/41; astrovirus; norovirus GI/GII; rotavirus, sapovirus) is assessed by RT-qPCR using a custom TAC in child stool collected cross-sectionally one or more days after enrollment. 2. Gene copy density of 27 enteric pathogens is assessed by RT-qPCR using a custom TAC in child stool collected cross-sectionally one or more days after enrollment. 3. Child weight and recumbent length (child age < 24 months) or standing height (24 – 60 months) is assessed according to standard World Health Organization (WHO) protocols and transformed to age-adjusted z-scores using WHO reference populations to obtain height-for-age (HAZ), weight-for-age (WAZ), and weight-for-height (WHZ) z-scores, with stunting defined as HAZ < -2, underweight as WAZ < -2, and wasting as WHZ < -2, at the time of enrollment. 4. Caregiver-reported child diarrheal disease, defined as the passage of three or more loose or watery stools in a 24-hour period, or any bloody stool, in the past 7 days, is assessed by surveys administered to the child's caregiver at the time of enrollment. | — |
Countries
Mozambique
Outcome results
None listed