A randomised controlled field trial to assess the LifeStraw® personal water treatment device

ISRCTN	ISRCTN05111243
DOI	https://doi.org/10.1186/ISRCTN05111243
Secondary identifying numbers	1A

Submission date: 16/04/2007
Registration date: 26/06/2007
Last edited: 25/10/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Contact information

Dr Thomas Clasen
Scientific

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

Study information

Study design	Cluster randomised trial. Unit of randomisation is the household.
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Prevention
Scientific title	A randomised controlled field trial to assess the LifeStraw® personal water treatment device
Study hypothesis	LifeStraw® personal water treatment device for use in the home and outside the home reduces diarrhoea.
Ethics approval(s)	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).
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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)
Primary outcome measure	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 study start date	01/06/2007
Overall study end date	30/11/2007

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	280 households, around 1120 individuals
Participant inclusion criteria	1. Inadequate water supply 2. At least one child under the age of five years
Participant exclusion criteria	Adequate water supply.
Recruitment start date	01/06/2007
Recruitment end date	30/11/2007

Locations

Countries of recruitment

England
Ethiopia
United Kingdom

Study participating centre

London School of Hygiene & Tropical Medicine

London
WC1E 7HT
United Kingdom

Sponsor information

London School of Hygiene & Tropical Medicine (UK)
University/education

Keppel Street
London
WC1E 7HT
England
United Kingdom

Email	Helen.Edwards@lshtm.ac.uk
Website	http://www.lshtm.ac.uk/
"ROR"	https://ror.org/00a0jsq62

Funders

Funder type

Industry

Vestergaard Frandsen S.A. (Switzerland)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		17/06/2009	25/10/2021	Yes	No

Editorial Notes

25/10/2021: Publication reference added.