Diarrhoea Clinical Trial
Official title:
Assessment of the Health Benefits Associated With Consumption of Solar Disinfection of Drinking Water by Children Under Age 5 Years, With Particular Emphasis on Dysentery and Childhood Diarrhoea
SODISWATER was a health impact assessment study investigating the effect of sunlight to
inactivate microbial pathogens in drinking water. This study was carried out by observing
whether children younger than 5 years old who drink solar disinfected water were healthier
than those who did not. Health was measured by how often the children had diarrhoea or
dysentery.
Caregivers for the participants were given plastic bottles to place in the sun, water
samples were then collected from these plastic bottles to be analyzed. They were also
requested to fill in diarrhea diaries.
TESTABLE RESEARCH HYPOTHESES:
Health Impact Assessment: Children who use solar disinfected water will have:
(a) lower morbidity due to non-bloody diarrhoea and bloody diarrhoea (c) increased growth
rates (d) lower mortality (e) increased family productivity (f) decreased care-giver burden
(g) increased school attendance
The current evidence base for solar disinfection in the prevention of diarrhoeal disease in
children rests on three published studies. All share two significant weaknesses: all were
carried out in Kenya, in communities which have very high incidences of diarrhoeal disease
and water characterised by high levels of both turbidity and microbial contamination.
Furthermore, neither of the studies of diarrhoeal disease distinguished between dysentery
(associated with significant risk of mortality) and other sorts of diarrhoea, which carry a
far lower risk. The present study will extend the evidence base into communities at lower
risk and with higher water quality. Furthermore, by using pictorial diaries, dysentery can
be analysed as a specific health endpoint. Diarrhoea will be recorded consistent with the
World Health organisation definition: three or more loose or watery stools in a 24-hour
period and/or stools containing blood or mucus.
AIM OF THE PROJECT IN RELATION TO HEALTH IMPACT ASSESSMENT STUDIES:
The primary aim of the SODISWATER PROJECT is to demonstrate that SODIS is an appropriate
intervention against diarrhoeal and waterborne disease among communities in developing
countries and those affected by natural or man-made disasters by conducting multi-centred
epidemiologically controlled Health Impact Assessments of the SODIS technique across the
African Continent under a variety of social, geographical and climactic conditions.
SCIENTIFIC OBJECTIVES OF SODISWATER IN RELATION TO HEALTH IMPACT ASSESSMENT STUDIES:
1. Assessment of the change in health reasonably attributed to the provision of solar
disinfected drinking water at the point of use in 3 countries (Kenya, Zimbabwe and
Cambodia).
2. Assessment of the relationship between solar disinfected drinking water and selected
health indicators (including morbidity due to non-bloody diarrhoea and dysentery,
weight loss, mortality, growth rates, productivity, care-giver burden, and school
attendance. Mortality will also be monitored but the sample sizes are of insufficient
size to produce detailed information and scaling up, to account for this is not
possible due to prohibitive costs).
3. Demonstration of the effectiveness of SODIS at household level.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01214785 -
Cluster Randomised Trial of Improved Sanitation in Rural Orissa, India
|
N/A | |
Recruiting |
NCT05073003 -
A Study on the Safety and Immune Responses to the GVGH altSonflex1-2-3 Vaccine Against Shigellosis in Adults, Children, and Infants
|
Phase 1/Phase 2 | |
Completed |
NCT01969214 -
Safety and Efficacy of IQP-MM-101 in Reducing Symptoms of Diarrhoea
|
N/A | |
Completed |
NCT01202383 -
Double-blinded Trial of Household-based Chlorination in India
|
Phase 3 | |
Completed |
NCT01087892 -
Probiotics in Preventing Antibiotic Associated Diarrhoea Including Clostridium Difficile Infection
|
N/A | |
Completed |
NCT00979056 -
Prophylactic Treatment of Travellers' Diarrhoea With Rifaximin
|
Phase 3 | |
Completed |
NCT02072629 -
HCU: Can VHVs Trained in ICCM Improve Care for Children
|
N/A | |
Completed |
NCT00408356 -
Immunological and Clinical Responses to Zinc in Children With Diarrhoea
|
Phase 3 | |
Completed |
NCT01517230 -
Can Mass Media Campaigns Reduce Child Mortality
|
N/A | |
Completed |
NCT02858609 -
Improving the Diagnosis of Diarrhoea in Emergency Rooms
|
N/A | |
Completed |
NCT00352716 -
Effectiveness of Smecta in the Treatment of Acute Diarrhoea in Children
|
Phase 3 | |
Active, not recruiting |
NCT02606526 -
Early Versus Late BCG Vaccination in HIV-1 Exposed Infants in Uganda in Uganda
|
Phase 3 | |
Completed |
NCT00352989 -
Effectiveness of Smecta in Combination With Oral Rehydration in the Treatment of Acute Watery Diarrhoea in Infants and Children
|
Phase 3 | |
Completed |
NCT00324285 -
Oral Rehydration SolutionContaining Amylase Resistant Starch in Severely Malnourished Children.
|
Phase 3 | |
Recruiting |
NCT02144168 -
The Effect of Enteral Nutrition Supplemented With Prebiotics on Colonic Microbiota in the Critically Ill Patients
|
N/A | |
Completed |
NCT02797353 -
Strengthening Maternal Neonatal and Child Health Services in a Rural District of Pakistan
|
N/A | |
Withdrawn |
NCT01491659 -
A Study to Evaluate the Effect and Safety of Idoform Plus on Bowel Side Effects in Healthy Subjects Treated With Amoxicillin/ Clavulanate
|
Phase 4 | |
Completed |
NCT01557673 -
Effects of Bolus and Continuous Nasogastric Feeding on Small Bowel Water Content and Blood Flow
|
Phase 1/Phase 2 | |
Completed |
NCT00823056 -
The Effect of Probiotics on Infections in Toddlers
|
Phase 3 | |
Completed |
NCT01154803 -
Effectiveness of Nutritional Supplementation in Preventing Malnutrition in Children With Infection
|
N/A |