A randomised controlled trial to assess the LifeStraw® Family household gravity filter

ISRCTN ISRCTN03844341
DOI https://doi.org/10.1186/ISRCTN03844341
Secondary identifying numbers N/A
Submission date
20/05/2008
Registration date
12/06/2008
Last edited
23/02/2011
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Thomas Clasen
Scientific

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

Phone + 44 (0)207 927 2916
Email Thomas.Clasen@lshtm.ac.uk

Study information

Study designTwo-armed randomised placebo-controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typePrevention
Participant information sheet Not available in web format, please use the contact details below to request a patient information
Scientific title
Study objectivesThe objectives of the study are:
1. To assess the effectiveness of the LifeStraw® Family household filter in preventing diarrhoeal diseases
2. To determine the effectiveness of the LifeStraw® household filter in reducing the bacterial load of drinking water
3. To evaluate the extent to which it is used correctly and consistently by, and is acceptable to, the target population
4. We will also measure longevity of the filter as it is used in a field setting
Ethics approval(s)Ethics approval received from:
1. The London School of Hygiene and Tropical Medicine (LSHTM) Ethics Board on the 15th November 2007 (ref: 5206)
2. Ecole de sante publique, Democratic Republic of Congo on the 22nd January 2008 (ref: ESP/CE/004/2008)
Health condition(s) or problem(s) studiedDiarrhoea
InterventionA two-arm randomised placebo-controlled trial will be conducted over a 12-month period. The trial will include two groups of households: half of the participating households will receive the LifeStraw® filter and the other half will receive a filter which looks like the LifeStraw® filter but which does not remove pathogens from the water.

The placebo has the same outside components as the real filter but the filtering membranes inside the cartridge have been replaced by some extra piping to imitate the weight of the real cartridge and the flow coming out of it.

Within one month of distributing the filters, field investigators will visit each household once a month (i.e. 12 visits per household during the overall follow-up period) to conduct a health survey. They will record for each household member, whether she/he had experienced any illness in the past 7 days, prompting a list of symptoms - in which diarrhoea is included - if no answer was spontaneously given.
Intervention typeOther
Primary outcome measureDiarrhoea longitudinal prevalence, measured as weekly period prevalence.
Secondary outcome measures1. Use of device, measured every month
2. Bacterial load reduction in drinking water, measured every month
3. Acceptability, measured once at the end of the study
Overall study start date01/06/2008
Completion date30/06/2009

Eligibility

Participant type(s)Patient
Age groupOther
SexBoth
Target number of participants240 households with around 1200 participants
Key inclusion criteriaHouseholds including members of all ages living in the study communities.
Key exclusion criteriaHouseholds and individuals who treat their water in a way that is deemed effective to prevent diarrhoea (e.g. boiling, filtration with a state of the art filter, regular use of bleach).
Date of first enrolment01/06/2008
Date of final enrolment30/06/2009

Locations

Countries of recruitment

  • Congo, Democratic Republic
  • England
  • United Kingdom

Study participating centre

DCVBU
London
WC1E 7HT
United Kingdom

Sponsor information

Vestergaard Frandsen (Switzerland)
Industry

Head Office - Switzerland
Chemin de Messidor 5 - 7
Lausanne
CH-1006
Switzerland

Phone +41 (0)21 310 7333
Email info@vestergaard-frandsen.com
Website http://www.vestergaard-frandsen.com/
ROR logo "ROR" https://ror.org/02fj56008

Funders

Funder type

Industry

Vestergaard Frandsen (Switzerland)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 10/09/2010 Yes No