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临床试验/NCT01214785
NCT01214785已完成不适用

Assessing the Effect of Improved Rural Sanitation on Diarrhoea and Intestinal Nematode Infections: a Cluster Randomised Controlled Trial in Orissa, India

London School of Hygiene and Tropical Medicine1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2010年9月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Diarrhoea (<5s)

研究概览

简要总结

The study is a cluster-randomized, controlled trial conducted among 100 villages (including approximately 3500 households and 20,000 people) in Puri district, State of Orissa, India. The study aims to assess the impact of the construction and use of latrines in rural settings on diarrhoeal disease, helminth infections and nutritional status. The study will also report on the cost and cost-effectiveness of the intervention and its impact on lost days at school and work as well as on expenditures on drugs and medical treatment. The study will document how the intervention actually impacts exposure to human excreta along principal transmission pathways by evaluating the impact on (i) faecal contamination of drinking water, (ii) the presence of mechanical vectors (flies) in food preparation areas, and (iii) the presence of faeces in and around participating households and villages. The study will also explore the extent to which different levels of acquisition and use of on-site sanitation among householders impact disease throughout the community.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Village level:
  • Little existing sanitation coverage (<10%)
  • WaterAid and implementing partners expects normal scale up
  • Stable and reasonably acceptable water supply
  • No other WASH interventions planned or anticipated in next 30 months
  • Reasonable year-round access by road to permit household visits by surveillance staff
  • Household level:
  • Presence of a child<4 or a pregnant woman
  • Consent to participate
  • Reside permanently in the village

排除标准

  • 未提供

研究组 & 干预措施

Sanitation intervention

Active Comparator

干预措施: Provision of household latrines (Behavioral)

Control

No Intervention

结局指标

主要结局

Diarrhoea (<5s)

时间窗: 21 months

Longitudinal prevalence of diarrhoea (7-day period prevalence) measured repeatedly every 3 months over a 21-month follow-up period. Diarrhoea is defined according to the WHO definition (three of more stools passed in 24 hrs)

次要结局

  • fly counts(21 months)
  • Soil-transmitted helminth infection(baseline and endline)
  • bacteriological water quality(21 months)
  • lost days at school and work(21 months)
  • latrine coverage and use(21 months)
  • Weight-for-age (<5s)(21 months)
  • healthcare expenditure(21 months)
  • Height-for-age(baseline and endline)
  • Diarrhoea (all ages)(21 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Thomas Clasen

Dr

London School of Hygiene and Tropical Medicine

研究点 (1)

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