Trial of Ceramic Water Filters to Reduce Cryptosporidium Infection in Kenya

Centers for Disease Control and Prevention (CDC)

Status: Completed

Conditions: Cryptosporidium; Diarrhea; Cryptosporidiosis; Diarrheal Disease; Communicable Diseases

Treatments: Other: Ceramic water filter

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01695304

CDCEID10A.1 (Other Identifier)

CDC-NCEZID-6369

2439 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 227 patients

Sex: All

Ages: 4 to 10 months old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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227 participants in 2 patient groups

Intervention Arm

Experimental group

Description:

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

Treatment:

Other: Ceramic water filter

Control Arm

No Intervention group

Description:

Households with a child 4-10 months old at initial entry into the study will not receive a ceramic water filter (control group). The study duration will be 6 months. All households in the control group will receive a Cera Maji ceramic water filter when the study ends.