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Diarrhoeal Disease clinical trials

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NCT ID: NCT05914363 Recruiting - Hookworm Infection Clinical Trials

Evaluating Impact of Improved Floors on Health

SABABU
Start date: April 12, 2023
Phase: N/A
Study type: Interventional

The goal of this intervention study is to learn about the impact of household flooring on health in rural Kenya, and test whether providing an improved (cement stabilised, washable) floor improves the health of children and their care providers. The main questions the study aims to answer are: - What is the effect of providing a sealed, washable floor on the prevalence of infections that cause diarrhoea, intestinal worms and sand flea infections? - To what extent does the intervention reduce contamination of floors with pathogens within the home? - What is its effect of the intervention on the wellbeing of caregivers and children? - Over the course of a year, do the new floors remain undamaged, with no cracks? - Do participants living with the new floors, and the masons that helped to install the floors, like them and feel they are practical and affordable? The study will involve a trial, where half of the recruited households will be randomly chosen to receive the new floor in addition to some support on how to care for the floor and keep it clean. The other half of households will not receive anything at first, but at the end of the research project will also receive a new floor. Before the new floors are installed, the investigators will make several assessments in all study households. These will include a survey to measure household characteristics; a stool survey, to measure how many people are infected with diarrhoea-causing microorganisms and parasitic worms; a jigger flea examination among children; wellbeing assessments among children and caregivers; and soil sampling to identify microorganisms on the floor of the household. When households receive the new floor, participants will have to move out of their house for up to 7 days during installation. Participants will also be asked to attend some group meetings to discuss ways of taking care of the floor and keeping it clean. Assessments will be repeated 12 months after the floor has been delivered, and additional interviews will be held with a small number of randomly selected participants. Throughout the 12 months following delivery of the intervention, investigators will make unannounced visits to households to check the condition of the floor. Participants will also be offered treatment for parasitic worm infections after assessments have been completed at the start and end of the project.

NCT ID: NCT04123119 Completed - Diarrhoeal Disease Clinical Trials

Development of a Live Attenuated Rotavirus Vaccine as a Human Infection Challenge Model

Start date: January 22, 2019
Phase: N/A
Study type: Interventional

The impact of licensed rotavirus vaccines in LMICs is limited by their lower immunogenicity and efficacy in these settings. Improved vaccines and vaccination schedules would result in substantially greater reductions in infant diarrhoeal disease and mortality. Placebo-controlled trials of new rotavirus vaccines are no longer ethical, leading to challenges for traditional routes of licensure for vaccines that are in the development pipeline. A HIC model of rotavirus would address these challenges, whilst also offering an opportunity to study the causes of poor oral vaccine immunogenicity. Rotarix™ is in routine use in Zambia administered at 6 and 10 weeks infant age. Shedding of rotavirus vaccine after vaccination has recently been explored as a measure of mucosal immunity, analogous to oral poliovirus vaccine challenge models. We propose to explore methodological development of an attenuated vaccine as a HIC model to advance rotavirus immunology and vaccinology in Zambian infants. We will evaluate use of minimally invasive procedures including sublingual/submandibular sampling and stool collection for viral shedding as measures of vaccine-induced and naturally acquired mucosal immunity. This approach holds the potential to develop the first rotavirus HIC model in a low-income country and could be used to accelerate licensure of new rotavirus vaccines and explore causes of poor oral vaccine efficacy as well as correlates of vaccine protection. To do this, we will recruit a cohort of 22 Zambian infants receiving Rotarix™ at 6 and 10 weeks as part of their routine immunisation. Infants will be followed up actively on the day of vaccination, days 1,3,5 and 7 following each vaccine dose for collection of stool and saliva samples. Blood samples for IgA and IgG titres will be collected on days 0, 28, 31 and 56, and standard ELISA methods used to determine vaccine seroconversion. The work brings together collaborators at the Centre for Infectious Disease Research in Zambia, Imperial College in UK and Christian Medical College, Vellore in India to prepare the Zambian centre as a potential HIC model site.

NCT ID: NCT02372851 Completed - Diarrhoeal Disease Clinical Trials

Assessing the Effectiveness of a Water Filter Technology as an Arsenic Mitigation Strategy in West Bengal

Start date: January 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether the use of a point-of-use water filtration technology can reduce the Arsenic content in drinking water and reduce the Arsenic body burden.

NCT ID: NCT02239250 Completed - Pneumonia Clinical Trials

Water Filters and Improved Cookstoves in Western Rwanda

Start date: August 2014
Phase: N/A
Study type: Interventional

DelAgua Health Rwanda (Implementation) Ltd. together with Rwanda Ministry of Health (MoH) are delivering an intervention, consisting on the free distribution of one advance water filter and one improved cookstove to all household classified as ubudehe 1 and 2 according to government approved registers (poorest tertile), in Western Province. The aim of this intervention is to reduce the morbidity and mortality associated with diarrhoeal diseases and pneumonia in Rwanda. The London School of Hygiene and Tropical Medicine (LSHTM) will be undertaking an independent evaluation of this large-scale intervention to assess its impact on health. The trial will evaluate whether the provision of improved cookstoves and advance water filters can reduce pneumonia and diarrhoea disease in children under 5 years of age. A cluster randomized controlled trial (CRCT) with two arms of unequal size (3:1 ratio) will be use to answer this question. The 96 sectors in Western Province, Rwanda, will be randomised to either receive the intervention or the control. Each eligible household in intervention sectors will receive one EcoZoom™ Spartan and one Vestergaard Frandsen Lifestraw Family™ 2.1 water filter free of charge. Eligible households in control sectors will continue with their traditional cooking and drinking practices. Health data on children under 5 years of age will be collected from community health worker (CHW) and health facility records all across Western Province to evaluate the health impact of the intervention. The study will encompass 12 months of follow-up. After this time the control sectors will receive the intervention. This independent evaluation will also include a nested village-level study within the larger sector-level study, with the aim to evaluate uptake, consistent use and acceptability of the intervention, as well as to assess the impact on environmental exposures and health outcomes. 174 villages (74 controls and 74 intervention) will be selected for participation. Household surveys will be used to collect data on intervention use and acceptability as well as on self-reported health data. Water samples will be collected and monitoring of exposure to Households Air Pollution (HAP) will be undertaken. Measurements of blood pressure, expirated Carbon monoxide (CO) and pulse CO-oximetry will be undertake in primary cooks and or children under 5 years of age. Additionally, as part of this nested study, two exploratory studies will also be conducted. One will be focused on assessing the potential of biomarkers as indicators of environmental exposures (mainly HAP and water quality) and health status, while the other exploratory sub-study will assess the reactivity of participants to the use of remotely reporting electronic sensors to measure target behaviours.

NCT ID: NCT02081521 Completed - Diarrhoeal Disease Clinical Trials

Evaluation of a Multiple Behaviour Programme for Diarrhoea Management

Start date: January 2014
Phase: N/A
Study type: Interventional

Control of diarrhoeal disease requires a comprehensive package of preventive and curative interventions. in Zambia, the Programme for Awareness and Elimination of Diarrhoea (PAED) aims to reduce child deaths by combating diarrhoea in Lusaka province, Zambia. The behaviour change component of the PAED programme seeks to change behaviours important for diarrhoea prevention (handwashing with soap and exclusive breastfeeding) and improved treatment outcomes (use of oral rehydration solution (ORS) and zinc in home management of child diarrhoea). The study aims to evaluate the feasibility of implementing a multiple behaviour change community programme to tackle diarrhoeal disease in children under-five and to assess the impact of this programme on practice of the target behaviours by caregivers of children under-five. The research questions will be answered through a a two-arm cluster-randomised trial (eight clusters per study arm).

NCT ID: NCT01350063 Completed - Diarrhoeal Disease Clinical Trials

Health Impact of Treating and Safely Storing Shallow Tubewell Drinking Water

Start date: February 2011
Phase: N/A
Study type: Interventional

When shallow tubewells replaced highly contaminated surface water as the primary source of drinking water in Bangladesh in the late 20th century, contemporary studies demonstrated no reduction in diarrheal disease with this improvement in water source. This lack of improvement in transitioning to tubewells is consistent with the lack of significant health gains observed in intervention studies focusing on water quality improvements at the source. In contrast, high quality intervention studies that improve water quality at the point of use through treatment of water in households show a 39% reduction in diarrhea. The primary objective of this study is within a typical setting in rural Bangladesh where households use shallow tubewell water for drinking. The investigators will randomly assign 1800 households who have a child between the ages of six months and two years to one of three groups. Group 1 will receive a safe water storage vessel with a lid and a narrow mouth/tap and Aquatabs, an effervescent water purification tablet that utilizes sodium dichloroisocyanurate (NaDCC) as the chlorine donor. Group 2 will only receive a safe water storage vessel with a lid and a narrow mouth/tap. Group 3 will receive no water intervention and continue their standard habits and practices. Every month a field research assistant will visit each participating household and collect information on the prevalence of diarrhea among children between the ages of six months and two years, as well as children between the ages of two and five years if present in the household. Diarrhea prevalence in the 48 hours and 7 days preceding the visit will be recorded. The investigators will compare the longitudinal prevalence of diarrhea between the following groups: (1) households that receive chlorine and storage container versus households that only receive storage container to assess the effect of chlorination, (2) households that only receive storage container versus households that receive no intervention to assess the effect of safe storage, and (3) households that receive chlorine and storage container versus households that receive no intervention to assess the combined effect of chlorination and safe storage. Hypothesis: Drinking water from shallow tubewells that are intermittently contaminated with enteric pathogens contributes importantly to diarrhea among children in rural Bangladesh.