Condition category
Digestive System
Date applied
16/04/2007
Date assigned
26/06/2007
Last edited
26/06/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Thomas Clasen

ORCID ID

Contact details

London School of Hygiene & Tropical Medicine
Keppel Street
London
WC1E 7HT
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1A

Study information

Scientific title

Acronym

Study hypothesis

LifeStraw® personal water treatment device for use in the home and outside the home reduces diarrhoea.

Ethics approval

Approval received from the London School of Hygiene and Tropical Medicine (LSHTM) Research Ethics Committee (REC) on the 21st February 2007 (ref: 5095). Local REC approval pending (Ministry of Health [MoH] Ethiopia).

Study design

Cluster randomised trial. Unit of randomisation is the household.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Condition

Diarrhoea

Intervention

All household members old enough to use the device will be given the personal water filter for use at home and away from home.

The control group will be referred to a medical facility when ill, like the intervention group. They will get the intervention device after the end of the study. The intervention period will be five months.

Intervention type

Device

Phase

Not Specified

Drug names

Primary outcome measures

Diarrhoea, this will be assessed every two weeks for the whole intervention period.

Secondary outcome measures

1. Microbiological water quality of treated water, this will be assessed every two weeks for the whole intervention period
2. Acceptability of the device, this will be assessed at the end of the study.

Overall trial start date

01/06/2007

Overall trial end date

30/11/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Inadequate water supply
2. At least one child under the age of five years

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

280 households, around 1120 individuals

Participant exclusion criteria

Adequate water supply.

Recruitment start date

01/06/2007

Recruitment end date

30/11/2007

Locations

Countries of recruitment

Ethiopia

Trial participating centre

London School of Hygiene & Tropical Medicine
London
WC1E 7HT
United Kingdom

Sponsor information

Organisation

London School of Hygiene & Tropical Medicine (UK)

Sponsor details

Keppel Street
London
WC1E 7HT
United Kingdom
Helen.Edwards@lshtm.ac.uk

Sponsor type

University/education

Website

http://www.lshtm.ac.uk/

Funders

Funder type

Industry

Funder name

Vestergaard Frandsen S.A. (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes