Drinking water under a "One Health" lens: quantifying microbial contamination pathways between livestock and drinking water
| ISRCTN | ISRCTN69058168 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN69058168 |
| Secondary identifying numbers | MR/P024920/1 |
- Submission date
- 11/12/2017
- Registration date
- 19/12/2017
- Last edited
- 23/04/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
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 December 2018
Who is funding the study?
Medical Research Council (UK)
Who is the main contact?
Dr James Wright
Contact information
Public
University of Southampton
Geography and Environment
Highfield
Southampton
SO17 1BJ
United Kingdom
 ORCID ID |
0000-0002-8842-2181 |
|---|
Study information
| 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 |
| Study setting(s) | Community |
| Study type | Prevention |
| Participant information sheet | ISRCTN69058168_ParticipantInformationSheet_v1.5_14Dec17.pdf |
| Scientific title | A longitudinal study of child diarrhoea and stored water contamination in rural Kenyan households in relation to livestock management and ownership |
| Study acronym | OneHealthWater |
| Study objectives | Livestock management and ownership affects faecal contamination of household stored water and thereby diarrhoea in children. |
| Ethics approval(s) | 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 |
| Health condition(s) or problem(s) studied | 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 | Other |
| Primary outcome measure | 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 study start date | 01/10/2016 |
| Completion date | 14/12/2018 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Child |
| Lower age limit | 6 Months |
| Upper age limit | 59 Months |
| Sex | Both |
| Target number of participants | 200 |
| Total final enrolment | 234 |
| Key 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 |
| Key exclusion criteria | Child's carer/parent unavailable or unable to provide informed consent |
| Date of first enrolment | 13/02/2018 |
| Date of final enrolment | 29/03/2018 |
Locations
Countries of recruitment
- Kenya
Study participating centre
PO Box 1578-40100
Kenya
Sponsor information
University/education
Research Governance Office
Building 37
Highfield
Southampton
SO17 1BJ
England
United Kingdom
| Website | https://www.southampton.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/01ryk1543 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Government organisation / National government
- Alternative name(s)
- Department for International Development, UK, DFID
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 14/12/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| 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 plan | The datasets generated during and/or analysed during the current study will be stored in a publically available repository at http://doi.org/10.5255/UKDA-SN-854302. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other files | Consent form version v1.5 |
14/12/2017 | 09/08/2018 | No | No |
| Participant information sheet | version v1.5 | 14/12/2017 | 09/08/2018 | No | Yes |
| Basic results | 07/06/2020 | 11/06/2020 | No | No | |
| Results article | 01/09/2020 | 23/04/2021 | Yes | No |
Additional files
- ISRCTN69058168_ParticipantInformationSheet_v1.5_14Dec17.pdf
- Uploaded 09/08/2018
- ISRCTN69058168_ConsentForm_v1.5_14Dec17.pdf
- Uploaded 09/08/2018
- ISRCTN69058168_BasicResults_07Jun2020.pdf
- Uploaded (11/06/2020)
Editorial Notes
23/04/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
11/06/2020: The following changes have been made:
1. The basic results of this trial have been uploaded as an additional file.
2. The IPD sharing statement has been added to the publication and dissemination plan.
09/08/2018: The following changes were made to the trial record:
1. The participant information sheet has been uploaded.
2. The recruitment start date was changed from 15/01/2018 to 13/02/2018.
3. The recruitment end date was changed from 15/03/2018 to 29/03/2018.
4. The overall trial end date was changed from 30/09/2018 to 14/12/2018.
5. The intention to publish date was changed from 01/10/2019 to 14/12/2019.
