Condition category
Digestive System
Date applied
11/12/2017
Date assigned
19/12/2017
Last edited
19/12/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Diarrhoeal disease and lack of access to safe water remain significant public health issues in developing countries. There is also growing concern about the potential for disease, including diarrhoeal infections, to be transmitted from livestock to humans. This project addresses the potential drinking-water contamination risks to human health in rural sub-Saharan Africa, where people and livestock often live in close proximity. Preliminary fieldwork will be carried out in rural Kenya, building on an ongoing study that is simultaneously recording human and livestock disease in ten villages. The fieldwork will test different techniques to identify contamination hazards from livestock, alongside water quality testing and recording of diarrhoea in children. These techniques will include checklists for recording signs of livestock hazards at water sources and around water stored in the home. The aim of this study is to look at how feasible it is to record hazards using these techniques and statistically assess whether we find greater water contamination and greater diarrhoea in children where there are more recorded hazards.

Who can participate?
Children aged 6-59 months old and their households.

What does the study involve?
Participants who agree to take part in the study are asked about how they store, treat and handle water in the home, as well as livestock-keeping, handwashing and sanitation arrangements. The study team makes observations of potential contamination hazards, both concerning water stored in the home and at water sources. The study team also takes samples of source water and of water stored in the home, testing these for microbial contamination. The team returns 12 weeks later, asking the same questions, taking the same water samples, and making the same observations. Participants are also asked about diarrhea in children 1 week and 13 weeks later as part of the ongoing study of human and livestock disease.

What are the possible benefits and risks of participating?
Where practical to do so, participants are provided with advice on steps that could be taken to reduce contamination risks affecting water sources such as wells or rainwater systems. There is potential for the study team to inadvertently contaminate stored water during sampling.

Where is the study run from?
Kenya Medical Research Institute (Kenya)

When is the study starting and how long is it expected to run for?
October 2016 to September 2018

Who is funding the study?
Medical Research Council (UK)

Who is the main contact?
Dr James Wright

Trial website

http://onehealthwater.org/

Contact information

Type

Public

Primary contact

Dr James Wright

ORCID ID

http://orcid.org/0000-0002-8842-2181

Contact details

University of Southampton
Geography and Environment
Highfield
Southampton
SO17 1BJ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MR/P024920/1

Study information

Scientific title

A longitudinal study of child diarrhoea and stored water contamination in rural Kenyan households in relation to livestock management and ownership

Acronym

OneHealthWater

Study hypothesis

Livestock management and ownership affects faecal contamination of household stored water and thereby diarrhoea in children.

Ethics approval

1. Kenya Medical Research Institute Scientific and Ethics Review Unit, 17/10/2017, ref: KEMRI/SERU/CGHR/091/3493
2. Ethics Committe of the Faculty of Social, Human and Mathematical Sciences, University of Southampton, 20/07/2017, ref: 25247

Study design

Prospective observational longitudinal study at a single centre, Siaya County, Kenya, with two sets of observations taking place in wet and dry seasons in a six month period

Primary study design

Observational

Secondary study design

Longitudinal study

Trial setting

Community

Trial type

Prevention

Patient information sheet

See additional files

Condition

Self-reported diarrhoeal disease

Intervention

Participants who give their informed consent to participate in the study are asked via questionnaire interview about how they store, treat and handle water in the home, as well as livestock-keeping, handwashing and sanitation arrangements. Recording observations and questionnaire responses via cell phone data entry, the study team makes observations of potential contamination hazards, both concerning water stored in the home and at water sources. The study team also takes samples of source water and of water stored in the home, testing these for two faecal indicator bacteria groups, E. coli and intestinal enterococci. The team then returns 12 weeks after baseline to administer the same questionnaire, taking the same water samples and testing these for faecal indicator bacteria, and making the same observations. Participants are also asked via questionnaire interview about diarrhea in children 1 week and 13 weeks after baseline, via their participation in the ongoing linked human and animal disease syndromic (PBASS) study. The total duration of observation is thus 13 weeks with 12 weeks of follow-up, thereby observing conditions in both wet and dry season.

Intervention type

Phase

Drug names

Primary outcome measures

E. coli and intestinal enterococci in household stored water are measured respectively through membrane filtration (0.45μm pore size) and culture with chromogenic coliform agar medium (incubation period: 24 hours) and m-Enterococcus agar medium (incubation period: 48 hours), followed by enumeration of both target organisms at baseline and 12 weeks thereafter.

Secondary outcome measures

Self-reported diarrhea (defined as ≥3 loose stools within a 24-hour period) is measured using questionnaire interview to household members at 1 week and 13 weeks.

Overall trial start date

01/10/2016

Overall trial end date

30/09/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Children aged 6-59 months (as the cohort at greatest risk of diarrhoeal disease) in households
2. Participating in an ongoing population-based animal syndromic surveillance (PBASS) study

Participant type

Healthy volunteer

Age group

Child

Gender

Both

Target number of participants

200

Participant exclusion criteria

Child's carer/parent unavailable or unable to provide informed consent

Recruitment start date

15/01/2018

Recruitment end date

15/03/2018

Locations

Countries of recruitment

Kenya

Trial participating centre

Kenya Medical Research Institute
Kisumu
PO Box 1578-40100
Kenya

Sponsor information

Organisation

University of Southampton

Sponsor details

Research Governance Office
Building 37
Highfield
Southampton
SO17 1BJ
United Kingdom

Sponsor type

University/education

Website

https://www.southampton.ac.uk/

Funders

Funder type

Government

Funder name

Medical Research Council

Alternative name(s)

MRC

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Funder name

Department for International Development

Alternative name(s)

Department for International Development, UK, DFID

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal with an approximate planned publication date of 01/10/2019. We do not plan to make our study protocol available.

IPD sharing statement:
The current data sharing plans for the current study are unknown and will be made available at a later date

Intention to publish date

01/10/2019

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes