Gut Health and Child Survival Scientific Priority Area

Child Survival

Many children suffer an elevated risk of mortality and chronic malnutrition months after acute infectious illnesses. This prolonged risk may be due to inadequately treated or new bacterial infections, a prolonged state of inflammation as a result of the infection and its associated treatment, or immune-deficiencies that arise after an illness.

Within clinical trials, we are testing whether empiric use of a broad-spectrum antibiotic improves post-infection survival in Kenyan children.  Through data and samples collected in these studies, we are building a platform to identify mechanisms and, eventually, to test additional interventions for reducing the short and long-term consequences of infectious diseases in children.

Growth and Nutrition

Recent estimates suggest that almost half of all childhood deaths are attributed to malnutrition. The relationship between malnutrition and enteric diseases is cyclical; malnutrition is a serious consequence of enteric and diarrheal disease and undernourished children experience a higher risk of death after infection.

Our team is leading a multi-country network of clinical research centers from Sub-Saharan Africa, South East Asia, the UK, and the USA dedicated to identifying risk factors that increase mortality, hospital readmission, and poor recovery in children who are malnourished and suffering from acute infection.

Enteric Disease and Function

Specific bacterial and parasitic enteric infections contribute a disproportionate burden to diarrheal disease, malnutrition, and poor academic performance.  We conduct an array of evidence-generating activities to inform international prevention and treatment policy of specific enteric infections including literature reviews challenging current management guidelines for Shigella infections, household Cryptosporidium transmission studies, and clinical trials testing the feasibility of integrated approaches to eliminating soil-transmitted helminths.

Neglected Tropical Diseases

Neglected tropical diseases, or NTDs, are a group of infections that disproportionately affect populations without adequate access to safe water, housing, or sanitation.  Often referred to as diseases of poverty, NTDs perpetuate inequities through associated morbidities such as blindness (trachoma and onchocerciasis), severe anemia, impaired growth and cognitive development (soil-transmitted helminths), elephantiasis (lymphatic filariasis), and other chronic conditions that prevented infected individuals from reaching their full income earning potential.  Our team has a suite of studies, including clinical trials and implementation research studies, that address opportunities to interrupt the transmission of several NTDs through the delivery of community-based interventions that are acceptable, feasible, and delivered with high coverage. 

Highly Vulnerable Populations

Implementation Science

Many of our studies include both a focus on the clinical effectiveness of new or existing therapeutics, as well as opportunities to improve the delivery of the evidence-based interventions.  Our research uses implementation science methods to determine the acceptability, appropriateness, cost, feasibility, fidelity, reach, and sustainability of different strategies to increase the impact of clinical interventions.  At the core of our implementation science work is a focus on equity and stakeholder engagement. 

Antibiotics for Children with Severe Diarrhea (ABCD)*

The ABCD Trial is a multi-site, double-blind, randomized trial that aims to determine if the addition of azithromycin to the standard management of care for acute non-bloody watery diarrhea for high-risk children in Sub-Saharan Africa and South Asia aged 2 to 23 months could reduce mortality and improve growth. 

Sponsor:  World Health Organization 

Award Years:  07/08/2014 – 07/31/2019

Principal Investigator:  Judd Walson, John Hopkins University

Primary Contact:  Patricia Pavlinac, UW

Click here to read the study protocol.

Azythromycin to Prevent Post-discharge Morbidity and Mortality in Kenyan Children (AZM)*

The Toto Bora Trial is a randomized, double-blind, placebo-controlled trial that aims to determine whether a short course of azithromycin (10 mg/kg on day 1 and 5 mg/kg on days 2-5) given to 1-59 month-old children with recent acute illness being discharged from hospitals reduces re-hospitalization, morbidity, and mortality. 

Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (5R01HD079695-04)

Award Years: 04/01/2015 – 02/29/2021

Principal Investigator:  Judd Walson, John Hopkins University

Primary Contact:  Patricia Pavlinac, UW

Click here to read the study protocol.

The Epidemiology of Extended Spectrum Beta Lactamase and Macrolide Resistance Genes in Kenyan Children Discharged from Hospital (AZM Royalty Grant)*

The AZM Royalty Grant aims to establish the burden, risk factors, and potential sharing of antibiotic resistance determinants using bacterial isolates from children recently discharged from hospital enrolled in the Toto Bora Trial.

Sponsor: University of Washington Royalty Research Fund

Award Years: 9/1/2020 – 9/30/2021

Principal Investigator: Patricia Pavlinac, UW

The role of enteric pathogens and antimicrobial resistance in driving clinical and nutritional deterioration, and azithromycin’s potential effect, among children discharged from hospital in Kenya (AZM Enterics)

Utilizing samples collected in the Toto Bora Trial, the AZM Enterics nested study utilizes aims determine associations between enteric bacterial pathogens detected at hospital discharge and risk of death, re-hospitalization, and growth failure in the six-month post-discharge and to evaluate if detection of these pathogens prior to randomization modifies azithromycin’s efficacy.

Sponsor: National Institute of Allergy and Infectious Diseases (5R01AI150978)

Award Years: 03/15/2020 – 02/08/2025

Principal Investigator: Patricia Pavlinac, UW

Enterics for Global Health (EFGH), Shigella surveillance study

EFGH is a multi-year facility-based, cross-sectional multi-country surveillance and longitudinal study at seven sites in Africa, Asia, and Latin America focusing on children under 36 months of age presenting with moderate-to-severe diarrhea (MSD) to generate data and quickly implement rigorous/efficient Shigella vaccine trials, accelerating the time to vaccine availability for children in low-middle income countries.

During Phases A and B, the EFGH Consortium built a robust collaborative research infrastructure to facilitate shared scientific decision making and protocol standardization, and recently completed enrollment of 9,476 participants in August 2024.

Each of the seven EFGH Consortium implementing sites and the UW coordination body received direct funding from the Gates Foundation (“Phase C”) to support results dissemination, site-led secondary data analysis, and implementation science activities to assess vaccine demand and policy maker preferences to maximize likelihood of future Shigella vaccine uptake and adoption.

Sponsor:  Gates Foundation

Award Years:  10/30/2019 – 4/30/2027

Principal Investigator: Patricia Pavlinac, UW

Collaborators: Asociación Benefica Prisma (PRISMA), Aga Khan University, icddr,b, Center for Vaccine Development in Mali (CVD-Mali), Malawi-Liverpool-Wellcome Trust (MLW) Clinical Research Programme, Medical Research Council Unit – The Gambia (MRCG), Emory University, University of Maryland Baltimore, University of Virginia

Modulation of EPEC susceptibility and severity by the microbiome*

The EPEC study is a cross-sectional study that aims to determine if a reduction in bacterial diversity through antibiotics use or HIV infection is associated with severe enteropathogenic Escherichia coli (EPEC) infection in HIV-exposed Kenyan children aged 6-12 months. 

Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (R21HD094639)

Award Years:  09/21/2017 – 08/31/2019

Principal Investigator:  William DePaulo

Primary Contact: Patricia Pavlinac, UW

Click here to read the study protocol.

Childhood Acute Illness and Nutrition Network (CHAIN) Cohort Study*

The CHAIN study is a multi-site, prospective, observational cohort study that aims to characterize the biomedical and social risk factors for mortality in acutely ill children (based on MUAC) aged 1 week to 2 years from four African and two South Asian countries in hospitals and after discharge. The CHAIN Consortium seeks to examine infectious, immunological, metabolic, nutritional, and other biological factors that link anthropometric status with risk of in-patient and post-discharge mortality. CHAIN includes several sub-studies, including MITS in CHAIN, Immunology, Body Composition, TB, Neurodevelopment, Breast Milk Composition, Enteric Function, HIV, Macronutrient Deficiencies, Social Science, and Skin CHAIN. 

Sponsor:  University of Oxford 

Award Years:  09/15/2015 – 09/30/2021

Principal Investigator: Judd Walson, John Hopkins University

Primary Contact: Kirk Tickell, UW

Click here to read the study protocol.

The CHAIN Consortium*

The CHAIN Consortium is a nested case-control study examining infectious, immunologic, metabolic, nutritional, and other biological mechanisms that link anthropometric status with risk for in-patient and post-discharge mortality, and are independently associated with mortality. The consortium is made up of laboratory partners from around the world.

Sponsor: Gates Foundation

Award Years: 11/25/2019 – 6/30/2022

Principal Investigator:  Judd Walson, John Hopkins University

Primary Contact: Kirk Tickell, UW

Surveillance and Epidemiologic Evaluation of COVID-19 in children with severe acute malnutrition and HIV in Kenya*

Through the partnership of Clinical Information Network (CIN) and CHAIN, the CHAIN-COVID prospective cohort study in Kenya aims to estimate the incidence of COVID and describe the clinical profile of highly vulnerable children and adults with SARS-CoV-2, including those with HIV and malnutrition. In addition, this study also aims to examine the use of respiratory care interventions and determine the impact of local COVID response on the ability of the Kenyan health system to continue delivering other health services.  

Sponsor: Gates Foundation

Award Years:  05/01/2020 – 6/30/2021

Principal Investigator:  Judd Walson, John Hopkins University

Primary Contact: Kirk Tickell, UW

Click here to read the study protocol.

Prevalence and correlates of pediatric guideline deviation across 9 health facilities*

The Pediatric Guideline study combines secondary data analysis and primary qualitative data collection from the CHAIN Network to understand drivers influencing provider adherence to or deviation from pediatric treatment guidelines and to design evidence-based interventions that can be applied to address adherence barriers.

Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (5R03HD099270)

Award Years: 09/17/2019 – 02/28/2022

Principal Investigator: Arianna Means, UW

Collaborators: Aga Khan University, icddr,b, Amsterdam University Medical Centres, KEMRI/Wellcome Trust Research Programme, Makerere University, Kamuzu University for Health Sciences, University of Oxford

Minimally Invasive Tissue Sampling to Improve Understanding of Cause of Death in Children (MITS in CHAIN)*

Case fatality rates among children hospitalized with acute illness are unacceptably high, even when current standards of care are applied. The Childhood Acute Illness and Nutrition (CHAIN) Cohort study aims to identify risk factors for and causes of death (CoD) among hospitalized children aged 2-23 months. Exact CoD are often unknown and difficult to establish, especially for malnourished children. This study aims to improve the understanding of CoD among well-characterized children who die during inpatient admission for acute illness across a spectrum of undernutrition in Malawi. We also introduce a novel strategy – post-mortem intestinal endoscopy and tissue sampling to assess its feasibility and as a method to understand the contribution of intestinal pathology to mortality. Additionally, we have commenced social sciences research to understand health worker, parent, and community leader’s concerns about MITS and barriers and facilitators to acceptance of MITS in Malawi.

Sponsor: University of Oxford

Award Years: 09/15/2017 – 09/30/2021

Principal Investigator: Donna Denno, UW

Minimally Invasive Tissue Sampling (MITS) for Lung Pathology and Immune Response in Fatal COVID-19 Patients in Malawi (MITS COVID-19)*

Even with access to optimum healthcare and intensive management, including mechanical ventilation in high-income settings COVID-19, caused by the SARS-CoV-2 virus kills 0.5 – 2% of infected individuals through a rapidly developing diffuse parenchymal lung disease and severe hypoxia. A vaccine may take many months to develop and longer to deploy. The virus may infect over 50% of the world’s population and without better treatments could cause upwards of 40 million deaths. Immunomodulation is a major prong of treatment investigatory efforts and may be particularly important as the pandemic spreads in low- and middle-income countries (LMICs), including sub-Saharan Africa (SSA), with much diminished intensive care capacity. Higher rates of malaria, HIV, and malnutrition may influence pathogenesis and immune response in these settings. To most effectively and safely target this immunomodulation it is important to understand the tissue-specific immune responses that drive severe disease in tissue, in particular in the lung.

Sponsor: Gates Foundation

Award Years: 08/03/2020 – 08/02/2021

Principal Investigator: Donna Denno, UW

Maternal Administered Malnutrition Monitoring System (Mama Aweza Trial)*

The Mama Aweza Trial is a randomized controlled trial that aims to establish the efficacy and feasibility of a novel malnutrition screening approach, in which caregivers are taught to use MUAC tapes. The caregivers are enrolled in a semi-automated mHealth SMS system that provides health education and MUAC monitoring support to improve early identification and linkage to care for malnourished Kenyan children aged 6-12 months. This scalable childhood growth monitoring system could enable nutrition programs in low and middle-income countries to optimize screening coverage, leading to early identification of malnutrition, lower costs, and a reduction in global under-five mortality.

Sponsor: Thrasher Research Fund

Award Years: 02/01/2019 – 03/31/2022

Principal Investigator: Christine McGrath, UW

Click here to read the study protocol.

Effects of Human Milk Oligosaccharides (HMO) and Gut Microbiome on Growth and Morbidity in HIV-Exposed Uninfected (HEU) Infants - the Tunza Mwana Study

The Tunza Mwana study is a prospective cohort study that aims to evaluate the association between maternal HIV infection, HMO composition, and the infant gut microbiome, and identify breast milk-mediated pathways associated with morbidity and linear growth in HEU infants born to Kenyan pregnant women between 28-42 weeks’ gestation. 

Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (5R01HD096999)

Award Years:  04/24/2019 – 03/31/2026 (NCE)

Principal Investigators: Christine McGrath, UW, Grace Aldrovandi, UCLA

The effect of the maternal plasma and breastmilk metabolome on the infant gut microbiome and growth

Despite breastfeeding and maternal anti-retroviral therapy, HIV-exposed uninfected infants have substantially higher risk of growth faltering and morbidity than HIV-unexposed uninfected infants. The proposed project will leverage a unique funded Tunza Mwana Kenyan birth cohort (NICHD 5R01HD096999) including lactating women living with and without HIV and their infants and expand this cohort to include targeted metabolomics of the maternal plasma and breastmilk to characterize the complex relationship between the mother-breastmilk-infant triad and identify metabolomic profiles associated with the infant gut microbiome and infant growth. Findings from this study will be used to develop targeted metabolomic and microbiome interventions for vulnerable HIV-exposed uninfected infants.

Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (K23HD113374)

Award Years:  08/08/2023 – 06/30/2028 

Principal Investigator: David Taylor Hendrixson, UW

Optimizing nutritional care for HIV exposed children in Migori and Homa Bay Counties - The Lishe Bora Study*

The Lishe Bora study uses qualitative data collection and systems analysis process mapping to evaluate provider adherence to HIV nutrition guidelines for HIV-exposed Kenyan children under two years of age in Migori and Homa Bay Counties to identify gaps in the care cascades and opportunities to more comprehensively integrate HIV and nutritional care. 

Sponsor: University of Washington Center for AIDS Research (CFAR) New Investigator Award

Award Years: 11/16/2020 – 11/15/2022

Principal Investigator: Arianna Means, UW

Feasibility of Interrupting the Transmission of Soil-transmitted Helminths (DeWorm3)*

The DeWorm3 Study is a series of community cluster randomized controlled trials that aim to determine the feasibility of interrupting soil-transmitted helminth transmission in focal geographical areas (Benin, India, and Malawi) by expanding the targeted population and the frequency of mass drug administration with albendazole. A follow-on investment to DeWorm3 aims to work with the extraction and real-time PCR-based testing of DeWorm3 stool samples for helminth infection to finalize the validation of this methodology, ensuring adequate accuracy, precision and reproducibility, and run approximately 100,000 samples from the 3 DeWorm3 countries through this high-throughput qPCR protocol to assess if the prevalence of STH is <2% soon after mass drug administration.

Sponsor: Gates Foundation

Award Years: 11/05/2015 – 9/30/2023

Principal Investigator:  Judd Walson, John Hopkins University

Primary Contact: Arianna Means, UW

Click here to read the study protocol.

Click here to read the implementation science protocol.

DeWorm3 DAC Trial Planning Grant (DeWorm3 Go!)*

The DeWorm3 Go! grant supports the expedited analysis of DeWorm3 data to inform data collection and analytical materials designed for use at study midline (after 3 years of MDA) and endline (after two years of surveillance). The analysis will derive interim biological, social, program, and economic- level correlates of MDA treatment coverage across four rounds of community-wide MDA, and inform the development of a targeted policy profile systematically inform the optimal characteristics and requirements of a practical operational guideline for STH transmission interruption programs.

Sponsor:  Gates Foundation

Award Years:  7/23/2020 – 7/22/2021

Principal Investigator: Arianna Means, UW

Neglected Tropical Disease Community of Practice (Kikundi)*

The NTD Community of Practice aims to foster professional development, pride and identity, community-based decision-making, access to technical expertise, and networking through a collaborative platform of African NTD program managers working to solve common neglected tropical disease implementation and management challenges.

Sponsor:  Gates Foundation

Award Years:  9/28/2020 – 9/14/2023

Principal Investigator: Arianna Means, UW

Collaborators: University of Global Health Equity (UGHE)

Neglected Tropical Disease Community of Practice (Kikundi 2.0)

After three years of start-up investment and platform refinement, the shared vision of BMGF and all funded partners is to continue growth of the CoP and to shift its management to Africa. In the next phase of Kikundi, University of Global Health Equity (UGHE) will lead all aspects of Kikundi management and growth and be the primary grant holder. UW will partner with UGHE as a strong thought partner, co-collaborator, and co-implementer. In Kikundi 1.0, a collaborative and effective partnership was formed between these two institutions, which will be instrumental to the successful execution of Phase 2. UW will provide strategic partnership and will be the lead in developing and supporting NTD Progam Managers to participate in novel training opportunities and provide support for M&E of the platform.

Sponsor:  Gates Foundation

Award Years:  4/216/2024 – 3/31/2027

Principal Investigator: Arianna Means, UW

Collaborators: University of Global Health Equity (UGHE)

Strengthening Economic Evaluation for Multi-sectoral Strategies for Nutrition (SEEMS-Nutrition)*

SEEMS-Nutrition is a multi-sectoral project that aims to fill an information gap on costs, cost-effectiveness, and benefits of scaling up food system strategies in resource-constrained areas combating malnutrition.  The findings will allow program implementers and policymakers to make informed decisions about which nutrition interventions to prioritize to address healthy food systems, dietary intake, and improved nutritional status.  Such interventions can help improve maternal-and-child health outcomes by promoting optimal dietary and feeding practices during critical windows of time when nutritional needs are the greatest.

Sponsor: Gates Foundation

Award Years:  11/05/2018 – 11/31/2024

Contact Principal Investigator:  Carol Levin, UW

Collaborators: Global Alliance for Improved Nutrition (GAIN), International Food Policy Research Institute (IFPRI), International Livestock Research Institute (ILRI), Helen Keller International (HKI), Results for Development (R4P)

Developing a Two-way SMS Platform to Prevent and Treat Wasting Among HIV-infected and HIV-exposed Uninfected Children (MAMMS IYCF)

This proposal will develop a novel two-way short message service (SMS) platform that targets key barriers to improving nutritional care for HEU and HIV-infected children. This intervention will combine a maternally administered malnutrition monitoring system (MAMMS) with infant and young child education (IYCF) delivered by SMS. After developing the intervention using participatory design methods, we will complete a proof-of-concept quasi-experimental trial of MAMMS-IYCF in the R21. If the R21 milestones are meet, we will use the R33 to conduct a randomized trial testing the effectiveness of MAMMS-IYCF at reduced the incidence wasting, and the duration of wasting treatment. During this trial we will also assess the cost and cost-effectiveness of MAMMS-IYCF, and to better understand which barriers are being successfully addressed by intervention we will measure its effect on key attitudinal and behavioral outcomes including trust in the healthcare system, intention to seek if a child becomes wasted, and IYCF knowledge.

Sponsor:  National Institutes of Health (R21HD110150, R33HD110150)

Award Years:  08/17/2022 – 07/01/2027

Principal Investigators:  Arianna Means, Kirk Tickell, UW

Technical Support to the Nigerian Institute of Medical Research (SARMAAN)

The SARMAAN project will establish an implementation science Technical Support Unit at the Global Center for the Integrated Health of Women, Adolescents, and Children (Global WACh), based at the University of Washington (UW). 

Sponsor:  The Royal Commonwealth Society for the Blind (Sightsaver)

Award Years:  04/01/2022 – 12/31/2027

Principal Investigator:  Arianna Means, UW

Collaborators: Nigerian Institute of Medical Research (NIMR)

Lactoferrin and lysozyme to promote nutritional, clinical, and enteric recovery: A factorial placebo-controlled randomized trial among children with diarrhea and malnutrition*

Lactoferrin and lysozyme are milk-derived nutritional supplements that may reduce the duration of diarrheal episodes, treat or prevent underlying enteric infections, improve enteric function, and accelerate nutritional recovery. However, it remains unclear whether their antimicrobial action will translate into significant improvements in the long-term clinical and nutritional outcomes of childhood diarrhea. We propose a factorial, double-blind, placebo-controlled, randomized trial to determine the efficacy and mechanisms of lactoferrin and lysozyme supplementation in minimizing the incidence of diarrhea and promoting nutritional recovery among children recovering from diarrhea and wasting. Kenyan children aged 6-24 months who have been discharged from an inpatient or outpatient hospital stay for diarrhea, and have a mid-upper arm circumference [MUAC] <12.5 cm will be randomized to 16-weeks of lactoferrin, lysozyme, a combination of the two, or placebo. This trial will provide much efficacy, mechanistic, and feasibility data from populations most likely to benefit from these interventions.

Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (R01HD103642)

Award Years:  01/01/2021 – 11/30/2025

Principal Investigator: Patricia Pavlinac, UW

A randomized trial of lactoferrin as a gut-friendly pediatric iron source in low-resource settings

Iron deficiency causes moderate and severe anemia, immunological impairment, and neurodevelopmental deficits, and is associated with linear growth failure. Most widely available iron supplements are poorly tolerated because of their gastrointestinal side effects and do not address the effect of inflammation on blocking iron uptake and sequestering iron within the body. This study, embedded in the Lactolyze parent trial, aims to establish the effect of lactoferrin on three key iron associated outcomes (hemoglobin concentration, linear growth, and neurodevelopment), and to establish if both lactoferrin’s supplemental iron and anti-inflammatory properties mediate its effect on these outcomes.

Sponsor: Thrasher Research Foundation

Award Years:  01/01/2024 – 12/31/2025

Principal Investigator: Kirk Tickell, UW

Micronutrient Status and Gut Health as Risk Factors for Relapse in Severe Wasting

Sponsor:  Action Against Hunger

Award Years:  05/01/2022 – 02/28/2026

Principal Investigator: Indi Trehan, UW

Addressing wasting and stunting in infants and young children by increasing the coverage and quality of selected high impact interventions in Ethiopia

This proposal is an evaluation of micronutrient status and gut health among wasted children and their community controls during and after CMAM treatment to provide information that may improve acute and post-recovery treatment. There is an evaluation of how much of the micronutrient recovery occurs during the “severe” phase of therapy when receiving RUTF and how much occurred during the “moderate” phase of therapy when receiving RUSF.

Sponsor:  Edesia Nutrition

Award Years:  10/10/2024 – 07/31/2026

Principal Investigator: Indi Trehan, UW

Multimorbidity in children with HIV and severe acute malnutrition in sub Saharan Africa

The University of Washington will coordinate research sites in western Kenya. These sites will recruit HIV infected and exposed children with severe acute malnutrition in observational study (year one) and then and series of interventional pilots testing behavioral and biomedical interventions in subsequent years.

Sponsor: National Institute for Health and Care Research

Award Years: 09/01/2021 – 12/31/2026

UW Principal Investigator: Kirk Tickell

Enhanced BReast and cErvical cAncer screening in Kenya THROUGH implementation science research and training (The BREAKTHROUGH Center)

Breast and cervical cancer kill many millions of women around the world, particularly in Sub-Saharan Africa, even though deaths and disability related to these cancers can be prevented by early detection and treatment. There are major gaps in the screening for and coordination of care to prevent women’s cancers in countries like Kenya; a profound inequity that threatens the health and well-being of women, their families, and communities. We propose to establish the Enhanced BReast and cErvical cAncer screening in Kenya THROUGH implementation science research and training (BREAKTHROUGH) Center, a partnership between institutions in Kenya, the US, and Canada improve women’s cancer control in Kenya.

Sponsor: National Cancer Institute (U54CA284036)

Award Years: 09/01/2023 – 08/31/2028

Principal Investigators: Michael Chung, Mohammed Kumail Ali, Emory University; John Kinuthia, Kenyatta National Hospital

UW Principal Investigator: Christine McGrath

Enhancing blood culture surveillance in WHO probiotic trial

The study aims to understand the impact of probiotic supplementation on culture confirmed sepsis in human milk fed preterm and term small for gestational age infants in South Asia and Sub-Saharan Africa.

Sponsors: World Health Organization, Gates Foundation

Award Years: 07/31/2024 – 08/31/2027

Principal Investigator: Kirk Tickell, UW

Planning for MNK02 - probiotic trial for underweight infants

This planning grant will support investigators at Kenya Medical Research Institute (KEMRI) plan for a rigorous clinical trial needed to understand optimal strains, dosing and duration of probiotic supplementation and their impact on underweight infants in Kenya.

Sponsor: Gates Foundation

Award Years: 09/01/2023 – 08/31/2028

Principal Investigators: Benson Singa, KEMRI

UW Contact: Kirk Tickell

Efficacy of probiotic supplementation in preterm and small for gestational age infants: A multi-centre, placebo-controlled, individually-randomised trial (PROPS Trial)

The trial will assess the effect of probiotic supplementation on mortality, morbidity, and growth in 14,000 enrolled preterm or term SGA infants in the first six months of life in five South Asian (Bangladesh, Pakistan) and Sub-Saharan African (Ethiopia, Kenya, Nigeria) countries with high rates of preterm birth and malnutrition among infants.

Sponsor: World Health Organization, Gates Foundation

Award Years: 07/01/2025 – 12/31/2028

Principal Investigator: Judd Walson, Johns Hopkins University

UW Principal Investigator: Kirk Tickell

The prevalence of antimicrobial resistance and effects on gut health among children who are HIV-exposed but uninfected

The study will investigate whether HIV-exposed, but uninfected children (CHEU) receiving cotrimoxazole prophylaxis may have a heightened susceptibility to AMR compared to children who are HIV-unexposed and uninfected (CHU) with similar sociodemographic and health characteristics. Specimens collected from the Linda Kizazi study (a research collaboration with the University of Washington, University of Nairobi, Kenyatta National Hospital, Fred Hutchinson Cancer Center, Emory University, and University of Montreal) will be tested and compared for AMR genes and pathogenic gut bacteria.

Sponsor: Thrasher Research Fund

Award Years: 07/01/2025 – 12/31/2026

Principal Investigator: Emily Begnel, UW