Wells e prova di trasmissione di malattie enteriche (WET - prova)
Wells e trasmissione di malattie enteriche: uno studio controllato randomizzato (studio WET)
Approximately 40 million people in the US are served by private wells, many of which are untreated. The investigators estimate that 1.29 million cases of gastrointestinal illness (GI) per year are attributed to consuming water from untreated private wells in the US. These cases of GI can cause a significant burden in terms of health care costs and lost work/school days, as well as increased risk to developing longer term health complications. This impact is magnified when accounting for vulnerable populations such as children under the age of 5, the elderly and the immunocompromised. The investigators are preparing to conduct the first household randomized controlled trial (RCT) to investigate whether consuming well water treated by ultraviolet light (UV) compared to consuming untreated private well water decreases the incidence of self-reported gastrointestinal illness and respiratory infections in children under 5. The investigators will collect illness symptom data using a combination of weekly text messages and online illness questionnaires.
Panoramica dello studio
Stato
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Pennsylvania
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Philadelphia, Pennsylvania, Stati Uniti, 19122
- Temple University
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Household must rely on a private groundwater supply (private well or spring)
- Child must be over six months and under 4 years old at enrollment so that they will be under five years of age for the duration of the 12-month study period.
- >75% of the water the child consumes must be tap water untreated by any treatment device capable of microbial water treatment. Proportion is estimated by the parent and includes water used to make juice or formula.
- Child must be a full-time resident of the home, defined as living in the home for five or more days every week. The intervention is administered at the household level; therefore the child must reside at home and be regularly exposed to the intervention.
Exclusion Criteria:
- Child has a chronic, gastrointestinal condition (e.g., Crohn's disease), which may complicate differentiation between signs and symptoms of gastrointestinal illness associated with drinking water and those of the pre-existing condition.
- Child is immunocompromised, which may result in increased susceptibility to waterborne illness. Daily oral steroids also considered an exclusion criteria due to their associated immunosuppressive effects.
- Parents are unable to submit data through short message service (SMS) text messages (smartphone was not required).
- Household treats their water for microbiological contamination at point-of-entry or point-of-use.
In the case where multiple children met the eligibility criteria, the youngest eligible child was enrolled. Records were maintained on the recruitment process documenting reasons for eligibility and those that declined to participate in the study.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Comparatore attivo: Active UV Device
A household water treatment device with a lamp emitting germicidal UV. The device will be operated at 50 millijoule per square centimeter to treat >99.9% of all bacteria, protozoa, and most viruses in water supplies. |
This point-of-entry treatment device will use germicidal UV to treat all of the well water used in the home. |
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Comparatore fittizio: Inactive UV Device
A device that appears identical to the active comparator device except the lamp will not emit germicidal UV. |
This sham device will use a lamp not emitting germicidal UV. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Incident gastrointestinal illness
Lasso di tempo: 12 months
|
The investigators will collect data on the presence of gastrointestinal illness symptoms through weekly text messages. Households that report symptoms through text messages will be directed to an online illness questionnaire to characterize the symptoms (incidence, severity, duration, diarrhea, vomiting, coughing, etc.), febrile episodes, as well as relevant exposure information such as recent travel, exposure to ill persons, etc. Incident gastrointestinal illness (GI) is defined by the reporting of a minimum of three episodes of diarrhea or vomiting in a 24 hour period. Each illness will be considered distinct when separated by ≥ 6 symptom-free days. |
12 months
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Acute respiratory illness (ARI)
Lasso di tempo: 12 months
|
As some waterborne pathogens (e.g., enterovirus and adenovirus) manifest with respiratory symptoms, we also captured ARI episodes, defined as: nasal congestion, nasal discharge, sore throat, mouth sores, or cough lasting at least one day, in the absence of another explanation such as isolated cough with a known history of asthma. Each incidence of respiratory infection was considered a unique illness event when preceded by ≥six symptom-free days. |
12 months
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Heather Murphy, PhD, Assistant Professor
Pubblicazioni e link utili
Pubblicazioni generali
- Hellard ME, Sinclair MI, Harris AH, Kirk M, Fairley CK. Cost of community gastroenteritis. J Gastroenterol Hepatol. 2003 Mar;18(3):322-8. doi: 10.1046/j.1440-1746.2003.02959.x.
- Johnson TD, Belitz K, Lombard MA. Estimating domestic well locations and populations served in the contiguous U.S. for years 2000 and 2010. Sci Total Environ. 2019 Oct 15;687:1261-1273. doi: 10.1016/j.scitotenv.2019.06.036. Epub 2019 Jun 6.
- Roberts JA, Cumberland P, Sockett PN, Wheeler J, Rodrigues LC, Sethi D, Roderick PJ; Infectious Intestinal Disease Study Executive. The study of infectious intestinal disease in England: socio-economic impact. Epidemiol Infect. 2003 Feb;130(1):1-11. doi: 10.1017/s0950268802007690.
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 25665 (Pilot Trial)
Piano per i dati dei singoli partecipanti (IPD)
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Informazioni su farmaci e dispositivi, documenti di studio
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