"The programme is effective in building latrines, but not all households participate," said lead author Professor Thomas Clasen from Emory University, Atlanta, US and the London School of Hygiene & Tropical Medicine in the UK, who conducted the study in 100 rural villages in Odisha.
"Moreover, many householders do not always use the latrines. This, combined with continued exposure from poor hygiene, contaminated water, and unsafe disposal of child feces, may explain the lack of a health impact," said Clasen.
Two-thirds of the 1.1 billion people who practice open defecation and a quarter of the 1.5 million who die every year from diarrhoeal diseases caused by poor hygiene and sanitation also live in India, they said.
This cluster randomised trial involved 9,480 households (50,951 individuals) in 100 rural villages in Odisha, with a child younger than 4 years or a pregnant woman.
Households in 50 villages were randomly assigned to receive the sanitation intervention in early 2011; control villages received the intervention after a 14-month surveillance period.
However, the researchers found no evidence that the intervention protected against diarrhoea in children younger than 5 years: 7-day prevalence of reported diarrhoea was 8.8 per cent in the intervention group (data from 1,919 children) and 9.1 per cent in the control group (1,916 children).
The intervention did not reduce the prevalence of parasitic worms that are transmitted via soil and can cause reduced physical growth and impaired cognitive function in children. There was also no impact on child weight or height - measures of nutritional status, researchers found.
"This rigorous assessment is important, because it provides the best evidence so far for the uncomfortable conclusion that well-funded, professionally delivered sanitation programmes, even when they reach coverage levels that are quite commendable for large scale interventions, do not necessarily improve health," Dr Stephen Luby, from Stanford University in the US, said.
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