PAthogen Transmission and Health Outcome Models of Enteric Disease

NCT05322655 | Completed

• 1 other identifier: 202004606
• Study Type: observational
• Target: 286
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the PATHOME study is to (1) develop statistical and computational methods for examining a complex disease system of interactions between and amongst children, animals, the environment, and enteric pathogens and (2) build a virtual laboratory for predicting which social and environmental developmental improvements best prevents multi-pathogen transmission to infants in urbanizing areas of high disease burden countries. Investigators will characterize how social and environmental development of urban neighborhoods in disease endemic settings modifies the "enteric pathome", i.e. the microbial communities of viral, bacterial, and protozoan pathogens transmitted by human and animal feces in the environment to infants. They will measure the impact of societal development on pathogen transmission to infants by applying a One Health ecosystem-based approach to characterizing interactions between enteric pathome agents in the environment and their transmission via interactions between infants, caregivers (CGs), animals, and environmental materials across domestic and public spaces and climate conditions. Data-validated statistical and computational models can quantify pathogen-specific attributable risk of infection through multiple pathways, and the extent that these risks are due to pathogen interactions with each other and the environment. The overall study hypothesis is that joint modeling of enteric pathome agents across urban households and neighborhoods representing transitional improvements in societal development will show that development leads to lower pathogen-specific detection frequencies, and thus evolution of the pathome from complex to simple microbial community structures. By studying spatial scale, developed and underdeveloped neighborhoods, specific transmission pathways, and seasonality in this process, the conditions that lead to the greatest declines in enteric disease incidence can be identified. This virtual laboratory will be built upon extensive data collection in two different Kenyan cities, including household and neighborhood economic indicators, clinical, zoonotic, and environmental microbiology, behavioral observation, geotracking of humans and domestic animals, climate conditions, population density, and infant anthropometry. This initial virtual lab will provide an evidence-based tool for predicting effective urban interventions to control fecally-transmitted disease in cities globally undergoing epidemiological transitions in infectious disease.

Conditions

Diarrhea, Infantile; Infection Gastrointestinal; Stunting; Wasting; Exposure

Keywords

gastrointestinal infections; feces exposure; infant growth; societal development; environmental contamination; enteric pathogens; hygiene

Outcome Measures

Primary Outcomes (3)

• enteric pathogen prevalence

  the proportion of infants who test positive by qRT-PCR for a specific type of enteric virus or bacteria at enrollment

  continuous over 14 days

• 14-day enteric pathogen incidence

  the proportion of infants whose feces tests positive by qRT-PCR for a specific type of enteric virus or bacteria that was not detected in feces at enrollment

  continuous over 14 days

• enteric pathogen diversity

  cumulative count of unique enteric pathogen types detected in infant feces at enrollment

  continuous over 14 days

Secondary Outcomes (6)

• 14-day self-reported diarrheal symptom prevalence

  continuous over 14 days

• stunting prevalence

  Day 3 or 5

• wasting prevalence

  Day 3 or 5

• preterm birth prevalence

  enrollment Day 1

• 7 day self-reported prevalence of prior symptoms

  enrollment Day 1

Other Outcomes (3)

• frequency of child exposure behaviors

  Day 2/3 of study

• presence and concentration of bacterial pathogens in the environment

  Day 2/3 of study

• presence and concentration of bacterial pathogens in feces of domestic animals

  Day 2/3 of study

Study Arms (4)

infants living in low-income neighborhoods of Nairobi

62 infants between 0 and 12 months age

infants living in middle-income neighborhoods of Nairobi

62 infants between 0 and 12 months age

infants living in low-income neighborhoods of Kisumu

62 infants between 0 and 12 months age

infants living in middle-income neighborhoods of Kisumu

62 infants between 0 and 12 months age

Eligibility Criteria

• Age: 1 Week - 12 Months
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

This study will recruit a cohort of infants between birth and 12 months of age, and their caregivers in urban neighborhoods of Kisumu and Nairobi, Kenya. The study focuses on infants in Kenya because infants in low-income urban Kenyan households and communities are exposed to pathogens via drinking water, food, objects, soil, and caregiver hands in the first months of life. Thus, detection of pathogens in infant feces is very high by six months age, indicating a rapid climb in enteric disease prevalence between birth and six months age. Recruitment of infants in the first months of life is necessary to detect the conditions that result in accumulation of these infections

You may qualify if:

• Infants between 0 and 12 months of age as verified by birth registration card;
• Infants who lack disabilities that would impact normal behavior;
• Infants who live permanently in the study neighborhood;
• Infant's primary guardian is greater than or equal to 18 years of age.

You may not qualify if:

• Infant age older than 12 months;
• Infant has a disability that impact's normal behaviors or health and development status;
• Infant's permanent resident is outside the study neighborhood;
• Infant's guardian is less than 18 years age, or an adolescent.

Sponsors & Collaborators

• State University of New York at Buffalo: lead
• African Population and Health Research Center: collaborator
• University of Iowa: collaborator

Study Sites (1)

African Population Health Research Center

Nairobi, 00000, Kenya

Location

Related Publications (2)

• Mberu B, Simiyu S, Gutema FD, Sewell D, Busienei PJ, Tumwebaze IK, Baker KK. Landscape analysis of the Kenyan policy on the treatment and prevention of diarrheal disease among under-5 children. BMJ Open. 2024 Aug 19;14(8):e081906. doi: 10.1136/bmjopen-2023-081906.

  PMID: 39160109 DERIVED

• Baker KK, Simiyu S, Busienei P, Gutema FD, Okoth B, Agira J, Amondi CS, Ziraba A, Kapanka AG, Osinuga A, Ouma C, Sewell DK, Gaire S, Tumwebaze IK, Mberu B. 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. BMJ Open. 2023 Nov 24;13(11):e076067. doi: 10.1136/bmjopen-2023-076067.

  PMID: 38000826 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Five feces specimens will be collected from each infant over a two week enrollment timeline. A 300 mg portion of each specimen will undergo DNA and RNA extraction using the Zymobiomics Pathogen Extraction kit.

MeSH Terms

Conditions

Diarrhea, Infantile; Growth Disorders; Cachexia

Condition Hierarchy (Ancestors)

Diarrhea; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Weight Loss; Body Weight Changes; Body Weight; Thinness

Study Officials

• Kelly K Baker, PhD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 6, 2021
• First Posted: April 12, 2022
• Study Start: November 15, 2021
• Primary Completion: March 13, 2024
• Study Completion: March 13, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE
• Time Frame: The full datasets should be available around the year 2025 to 2026 when the virtual lab model infrastructure is made public.
• Access Criteria: individuals using the data will be required to agree to cite the data source if used or reused for their own purposes. Otherwise access and re-use will not be restricted.

Locations

KE (1)