This trial is active, not recruiting.

Conditions diarrhoea, soil-transmitted helminth infection, nutritional status
Treatment provision of household latrines
Sponsor London School of Hygiene and Tropical Medicine
Collaborator WaterAid
Start date September 2010
End date December 2013
Trial size 100 participants
Trial identifier NCT01214785, MR03


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
(Active Comparator)
provision of household latrines
WaterAid and local NGO partners mobilize householders in target villages to construct and use latrines in accordance with the Government of India's Total Sanitation Campaign.
(No Intervention)

Primary Outcomes

Diarrhoea (<5s)
time frame: 21 months

Secondary Outcomes

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

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: 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

Additional Information

Official title Assessing the Effect of Improved Rural Sanitation on Diarrhoea and Intestinal Nematode Infections: a Cluster Randomised Controlled Trial in Orissa, India
Principal investigator Thomas Clasen, PhD
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by London School of Hygiene and Tropical Medicine.