Clinical trial NCT01695304: Trial of Ceramic Water Filters to Reduce Cryptosporidium Infection in Kenya
Official title: Pilot Intervention Trial of Ceramic Water Filters to Reduce the Burden of Cryptosporidium in Household Drinking Water in Rural Kenya.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cryptosporidium; Diarrhea
Cryptosporidiosis
Communicable Diseases
Diarrheal Disease
Keywords: Cryptosporidiosis
Waterborne disease
Diarrheal disease
Ceramic water filters
infants
young children
drinking water
Kenya
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
Collaborators: name: Kenya Medical Research Institute
First posted: 2012-09-27
Enrollment: 227
Sex: ALL
Minimum age (years): 4
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: 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.

Eligibility criteria: 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.

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Primary outcomes:
measure: Longitudinal Diarrhea Prevalence
timeFrame: 6 months
measure: Health Facility Visits for Diarrheal Disease
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kisumu
country: Kenya
facility: Kemri/Cdc
Study officials:
affiliation: Centers for Disease Control and Prevention
name: Eric Mintz, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: