Trial of Ceramic Water Filters to Reduce Cryptosporidium Infection in Kenya

Not Applicable

Completed

Conditions: Cryptosporidium; Diarrhea
Communicable Diseases
Cryptosporidiosis
Diarrheal Disease

Interventions: Other: Ceramic water filter

Registration Number: NCT01695304

Lead Sponsor: Centers for Disease Control and Prevention

Brief Summary: The aim of the study is to examine the efficacy of ceramic water filters to reduce the burden of waterborne diarrheal illness among infants in selected villages in Kenya. In Kenya very young children are given drinking water or water is used in reconstitution of their food. We hypothesize that ceramic water filters will remove Cryptosporidium from drinking water reducing infection in infants.

Detailed Description: Diarrhea is a major cause of illness among children in Africa. Cryptosporidium is a protozoan waterborne diarrheal pathogen resistant to chlorine. Ceramic filters are effective at improving drinking water quality, including removal of protozoa. In a recent preliminary analysis of \>22,000 children \<5 years enrolled in the Global Enterics Multi-Center Study (GEMS) case-control study of moderate-to-severe diarrhea, Cryptosporidium was identified as a leading cause of diarrhea in infants across all four participating African sites. This pilot is the first Cryptosporidium specific intervention trial of household ceramic water filters to reduce the burden of cryptosporidiosis acquired through drinking water in rural Kenya.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 227

Inclusion Criteria

Children 4-10 months old living in selected villages in the Asembo Health and Demographic Surveillance System (HDSS) study area in Kenya whose primary caretakers consent on their behalf to be visited weekly for 6 months to carry out weekly illness surveillance, and have a follow up home visit one year after initial enrollment into the trial. The household in which the child resides must be a consenting participant in the HDSS. As the children included in the trial are infants, the child's primary caretaker will be invited to participate and be administered questionnaires. Random selection will be at the compound level. Only one household per compound will be eligible for selection.

Exclusion Criteria

Children 4-10 months old whose households are not active consenting participants in the HDSS will not be eligible for inclusion. Only the subset of children 4-10 months old who are randomly selected in the sample will be eligible for participation.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Arm	Ceramic water filter	Households with a child 4-10 months old will receive a Cera Maji ceramic water filter for treatment of drinking water.

Primary Outcome Measures

Name	Time	Method
Longitudinal Diarrhea Prevalence	6 months	The primary outcome measure is the longitudinal prevalence of diarrheal disease.
Health Facility Visits for Diarrheal Disease	6 months	incidence rate of health facility visits for diarrheal disease per 100 person-week of observation

Secondary Outcome Measures