Completed

Pilot Intervention Trial of Ceramic Water Filters to Reduce the Burden of Cryptosporidium in Household Drinking Water in Rural Kenya.

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What is being tested

Ceramic water filter

Other
Who is being recruted

Animal Diseases+17

+ Coccidiosis

+ Digestive System Diseases

From 4 to 10 Months
See all eligibility criteria
How is the trial designed

Prevention Study

Interventional
Study Start: January 2013
See protocol details

Summary

Principal SponsorCenters for Disease Control and Prevention
Last updated: March 22, 2017
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2013

Actual date on which the first participant was enrolled.

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.

NCT01695304
Principal SponsorCenters for Disease Control and Prevention
Last updated: March 22, 2017
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

227 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 4 to 10 Months

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Animal DiseasesCoccidiosisDigestive System DiseasesGastrointestinal DiseasesInfectionsIntestinal DiseasesIntestinal Diseases, ParasiticParasitic DiseasesParasitic Diseases, AnimalPathologic ProcessesProtozoan InfectionsProtozoan Infections, AnimalSigns and SymptomsSigns and Symptoms, DigestivePathological Conditions, Signs and SymptomsDisease AttributesWaterborne DiseasesCommunicable DiseasesCryptosporidiosisDiarrhea

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. -

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Group II

No Intervention
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.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Kemri/Cdc

Kisumu, KenyaOpen Kemri/Cdc in Google Maps
CompletedOne Study Center