Condition category
Infections and Infestations
Date applied
05/03/2019
Date assigned
20/03/2019
Last edited
01/04/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
This study aims to evaluate different methods of measuring infant diarrhoea prevalence in refugee camps and slums. Currently, the accepted method of doing this is by asking parents if their child has had two or more loose or watery stools in the past two weeks. However, this measurement can lead to an incorrect result due to problems with memory, not answering truthfully, or not understanding the question. As an alternative, in this study this method will be tested against more in depth questions and sampling of stool to test for causes of diarrhoea.

Who can participate?
Household with at least one adult over the age of 18 and children under the age of five in the Cox’s bazar refugee camp

What does the study involve?
The study involves selection of 400 households by house to house surveying, recruiting consenting households who have a child under the age of five. Consenting households are initially given a survey on their demographics, health status, and access to care, toilets, and water. Households are then randomly allocated to receive either the enhanced survey or the standard survey. 20 households from each survey who report diarrhoea, and 20 surveys from each survey who don’t report diarrhoea, are also asked to provide stool samples. Stool samples are collected, visually inspected by a researcher for presence of diarrhoea, and sent for laboratory analysis. Households are first surveyed in April, a time with low diarrhoea prevalence; and again in June/July, a time with high diarrhoea prevalence.

What are the possible benefits and risks of participating?
There are no benefits to participating, with no compensation. However, if a participant gives an answer indicating that the child requires medical care, or if stool samples indicate that medical care is required, the carer will be notified. Risks include discomfort with questions being asked, and discomfort collecting stool. Households will be instructed that they are free to stop the survey and withdraw at any time. A small amount of risk results in data being traceable back to participants, however, all measures have been taken to mitigate this – including storing identifiers and data separately; and encryption of all data on a secure server.

Where is the study run from?
University of Warwick (UK) and International Center for Diarrhoeal Disease Research (Bangladesh)

When is the study starting and how long is it expected to run for?
November 2018 to August 2019

Who is funding the study?
University of Warwick (UK)

Who is the main contact?
1. Ryan Rego
ryan.rego@warwick.ac.uk
2. Dr Samuel Watson
s.watson.1@warwick.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Mr Ryan Trevor Titus Rego

ORCID ID

http://orcid.org/0000-0003-1361-9366

Contact details

Warwick Medical School
University of Warwick
Coventry
CV47AL
United Kingdom
+44 (0)7462890990
ryan.rego@warwick.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

REGO-2019-2345

Study information

Scientific title

Comparison of traditional diarrhoea measurement methods with microbiological indicators

Acronym

DiarrhoeaMeasurement

Study hypothesis

The researchers hypothesise that traditional methods of measuring diarrhoea prevalence in infants (asking questions on loose stools in the past two weeks) are plagued by several issues, including recall bias, social desirability, and ascertainment bias. To evaluate this, the researchers are comparing traditional diarrhoea measurement questions against two alternatives: an enhanced questionnaire using pictorial representation, and stool sampling for visual inspection and microbiological analysis.

Ethics approval

1. Approved 27/02/2019 by the Warwick Biomedical & Scientific Research Ethics Committee in the UK, Contact: Emily Dight, Research Support Officer- Governance & Ethics, University House, University of Warwick, Coventry, CV4 7AL, UK, Tel: +44 (0)24 765 73961, Email: E.C.Dight@warwick.ac.uk, ref: REGO-2019-2345
2. This study has also been submitted to the ICDDR,B Ethics Research Committee in Bangladesh

Study design

Observational longitudinal cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Home

Trial type

Screening

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Diarrhoea/enteric infection

Intervention

Initially 400 households will be randomly selected, of which 200 will be randomised by block randomisation to receive the standard survey (standard diarrhoea measurement questions), and 200 to receive the enhanced survey (with pictorial representation). From each arm, 20 households reporting diarrhoea and 20 not reporting diarrhoea will be chosen for stool sampling.

The study will collect baseline data in April 2019, with follow-up in June/July 2019. The study will be taking place in Camp 18 (Balukhali) of the Cox's Bazar refugee camp in Bangladesh.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Diarrhoea prevalence measured through standard survey or enhanced survey at baseline (April 2019) and endline (June/July 2019)

Secondary outcome measures

Pathogenic profile measured by microbiological analysis of stool at baseline (April 2019) and endline (June/July 2019)

Overall trial start date

01/11/2018

Overall trial end date

01/08/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Household has at least one child under the age of five
2. Household has at least one adult over the age of 18
3. Household consents to study

Participant type

Mixed

Age group

Mixed

Gender

Both

Target number of participants

400

Participant exclusion criteria

Household is expecting to relocate/resettle/repatriate in the next 6 months

Recruitment start date

20/03/2019

Recruitment end date

10/04/2019

Locations

Countries of recruitment

Bangladesh

Trial participating centre

ICDDR,B
68, Shaheed Tajuddin Ahmed Sarani
Dhaka
1212
Bangladesh

Sponsor information

Organisation

University of Warwick

Sponsor details

RIS
University House
Coventry
CV4 7AL
United Kingdom
+44 (0)24 76 524760
wmsgrantssupport@warwick.ac.uk

Sponsor type

University/education

Website

warwick.ac.uk

Funders

Funder type

University/education

Funder name

University of Warwick

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

United Kingdom

Results and Publications

Publication and dissemination plan

1. Conference presentation (Water and Health 2019, USA)
2. Manuscript (TBD)

IPD sharing statement
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.

Intention to publish date

01/11/2019

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

01/04/2019: Uploaded protocol (not peer reviewed) 06/03/2019: Trial's existence confirmed by Warwick Biomedical & Scientific Research Ethics Committee.