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

ISRCTN	ISRCTN05111243
DOI	https://doi.org/10.1186/ISRCTN05111243
Protocol serial number	1A
Sponsor	London School of Hygiene & Tropical Medicine (UK)
Funder	Vestergaard Frandsen S.A. (Switzerland)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Thomas Clasen
Scientific

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

Primary study design	Interventional
Study design	Cluster randomised trial. Unit of randomisation is the household.
Secondary study design	Randomised controlled trial
Scientific title	A randomised controlled field trial to assess the LifeStraw® personal water treatment device
Study objectives	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).
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)
Primary outcome measure(s)	Diarrhoea, this will be assessed every two weeks for the whole intervention period.
Key secondary outcome measure(s)	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.
Completion date	30/11/2007

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	1120
Key inclusion criteria	1. Inadequate water supply 2. At least one child under the age of five years
Key exclusion criteria	Adequate water supply.
Date of first enrolment	01/06/2007
Date of final enrolment	30/11/2007

London School of Hygiene & Tropical Medicine

London
WC1E 7HT
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

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

25/10/2021: Publication reference added.