The Sanitation Hygiene Infant Nutrition Efficacy (SHINE) Trial: Rationale, Design, and Methods
Open accessAbstract
UNLABELLED: Child stunting and anemia are intractable public health problems in developing countries and have profound short- and long-term consequences. The Sanitation Hygiene Infant Nutrition Efficacy (SHINE) trial is motivated by the premise that environmental enteric dysfunction (EED) is a major underlying cause of both stunting and anemia, that chronic inflammation is the central characteristic of EED mediating these adverse effects, and that EED is primarily caused by high fecal ingestion due to living in conditions of poor water, sanitation, and hygiene (WASH). SHINE is a proof-of-concept, 2 × 2 factorial, cluster-randomized, community-based trial in 2 rural districts of Zimbabwe that will test the independent and combined effects of protecting babies from fecal ingestion (factor 1, operationalized through a WASH intervention) and optimizing nutritional adequacy of infant diet (factor 2, operationalized through an infant and young child feeding [IYCF] intervention) on length and hemoglobin at 18 months of age. Within SHINE we will measure 2 causal pathways. The program impact pathway comprises the series of processes and behaviors linking implementation of the interventions with the 2 child health primary outcomes; it will be modeled using measures of fidelity of intervention delivery and household uptake of promoted behaviors and practices. We will also measure a range of household and individual characteristics, social interactions, and maternal capabilities for childcare, which we hypothesize will explain heterogeneity along these pathways. The biomedical pathway comprises the infant biologic responses to the WASH and IYCF interventions that ultimately result in attained stature and hemoglobin concentration at 18 months of age; it will be elucidated by measuring biomarkers of intestinal structure and function (inflammation, regeneration, absorption, and permeability); microbial translocation; systemic inflammation; and hormonal determinants of growth and anemia among a subgroup of infants enrolled in an EED substudy. This article describes the rationale, design, and methods underlying the SHINE trial. CLINICAL TRIALS REGISTRATION: NCT01824940.
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Previous water treatment and sanitation intervention trials conducted in urban informal settlements or peri-urban settings have typically only based effectiveness on demonstrated reductions in child diarrhea and/or improvements in child growth.
“Previous water treatment and sanitation intervention trials conducted in urban informal settlements or peri-urban settings have typically only based effectiveness on demonstrated reductions in child diarrhea and/or improvements in child growth 110,112-114 .”
From Urban informal settlements as hotspots of antimicrobial resistance and the need to curb environmental transmission. (2020) · cites this paper as [113]
The section “Among WASH Interventions, Sanitation May Be Central” reports child-growth results from a review of five water-quality and handwashing trials. The “WASH May Be More Strongly Associated With Child Stunting Than With Diarrhea” section also discusses diarrhea and growth, but largely in observational studies. Neither passage establishes that trials in urban informal or peri-urban settings typically judged effectiveness only by those outcomes; the five trials cited in the review did not include improved sanitation. (LLM, conf=0.78)
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Environmental enteric dysfunction and child stunting
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- Authors
- Humphrey, J. H., Jones, A. D., Manges, A. R., Mangwadu, G., Maluccio, J. A., Mbuya, M. N. N., Moulton, L. H., Ntozini, R., Prendergast, A. J., Stoltzfus, R. J., & Tielsch, J. M.
- ORCID
- Venue
- Clinical Infectious Diseases
- Publisher
- Oxford University Press (OUP)
- Published
- 2015-11-24
- Volume
- 61
- Issue
- suppl 7
- Pages
- S685-S702
- ISSN
- 1058-4838 (ISSN-L)
- 1537-6591
- PMC
- PMC4657589
- OpenAlex
- W2311594836
- Cited by
- 161
- References
- 95
- Citations by year
- 2026: 6 · 2025: 7 · 2024: 20 · 2023: 10 · 2022: 14 · 2021: 11 · 2020: 22 · 2019: 21 · 2018: 19 · 2017: 17 · 2016: 6 · 2015: 7
- FWCI
- 15.74
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Clinical Infectious Diseases (publishedVersion)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Funders
- the Bill & Melinda Gates Foundation (OPP1021542 and OPP1143707)
- Department for International Development
- Wellcome Trust (093768/Z/10/Z)
- Swiss Agency for Development and Cooperation
- National Institutes of Health (2R01HD060338-06)
- Topics
- Health Sciences › Nursing › Nutrition and Dietetics › Child Nutrition and Water Access
- Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Public Health and Nutrition
- Health Sciences › Nursing › Nutrition and Dietetics › Infant Nutrition and Health
- Keywords
- environmental enteric dysfunction, child stunting, infant anemia, water, sanitation and hygiene, infant and young child feeding, infant nutrition, chronic inflammation, microbial translocation, intestinal permeability, hemoglobin, infant growth, Zimbabwe
- MeSH terms
- Anemia, Eating, Feces, Female, Growth Disorders, Hemoglobins, Humans, Hygiene, Infant, Intestines, Male, Research Design, Rural Population, Sanitation, Zimbabwe, Multicenter Studies as Topic, Randomized Controlled Trials as Topic
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
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