A randomised controlled trial to assess the LifeStraw® Family household gravity filter
| ISRCTN | ISRCTN03844341 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN03844341 |
| Protocol serial number | N/A |
| Sponsor | Vestergaard Frandsen (Switzerland) |
| Funder | Vestergaard Frandsen (Switzerland) |
- 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
Scientific
DCVBU
London School of Hygiene and Tropical Medicine
Keppel Street
London
WC1E 7HT
United Kingdom
| Phone | + 44 (0)207 927 2916 |
|---|---|
| Thomas.Clasen@lshtm.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Two-armed randomised placebo-controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | |
| Study objectives | The 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) studied | Diarrhoea |
| Intervention | A 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 The placebo has the same outside components as the real filter but the filtering membranes inside the cartridge have been replaced by some extra piping to imitate the weight of the real cartridge and the flow coming out of it.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 type | Other |
| Primary outcome measure(s) |
Diarrhoea longitudinal prevalence, measured as weekly period prevalence. |
| Key secondary outcome measure(s) |
1. Use of device, measured every month |
| Completion date | 30/06/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | All |
| Target sample size at registration | 1200 |
| Key inclusion criteria | Households including members of all ages living in the study communities. |
| Key exclusion criteria | Households 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 enrolment | 01/06/2008 |
| Date of final enrolment | 30/06/2009 |
Locations
Countries of recruitment
- United Kingdom
- England
- Congo, Democratic Republic
Study participating centre
DCVBU
London
WC1E 7HT
United Kingdom
WC1E 7HT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
