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CompletedNCT01538953Updated Feb 27, 2012

Pakistan Flocculent Health Outcome Study

An interventional study of handwashing and flocculent-disinfectant for water treatment in Diarrhea, sponsored by Centers for Disease Control and Prevention. Completed at 1 site in Pakistan. Per ClinicalTrials.gov, last updated 2012-02-27.

Sponsored by Centers for Disease Control and Prevention · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
8,949
Allocation
Randomized
Sex
All
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Study summary

This study is designed to evaluate the effect of different methods of drinking water treatment on the occurrence of diarrhea among children living in squatter settlements in Karachi, Pakistan, and the marginal benefit of adding handwashing to water treatment. 260 households will receive a new product which combines flocculation with chlorination to produce clearer, less chemically contaminated drinking water. 260 households will receive dilute sodium hypochlorite, i.e. bleach to treat their water. 260 households will receive soap and encouraged to wash their hands regularly. 260 households will receive both soap and the combination flocculation/chlorination water treatment. 260 households will continue their standard water treatment and handwashing practices. The households will be visited each week for 9 months, and the episodes of diarrhea from each child in the household recorded. The rate of diarrhea between the groups will be compared. At the end of 9 months, households who were part of the standard habits and practice group will receive a water storage vessel and disinfectant.

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Conditions studied

  • Diarrhea

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Keywords

  • diarrhea
  • handwashing
  • point-of-use water treatment
  • diarrhea longitudinal prevalence
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In context

Diarrhea

852 studies on the registry are indexed under Diarrhea; 78 are open to participants now.

This study's enrollment of 8,949 is above the median of 136 across 713 interventional studies indexed under Diarrhea.

Browse Diarrhea studies →

Lead sponsor

Centers for Disease Control and Prevention is the lead sponsor of 273 studies on the registry; 2 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 8 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • households in study neighborhoods
  • contain a child \< 5 years old
  • have access to water for handwashing

Exclusion criteria

Exclusion Criteria:

  • participated in handwashing or drinking water treatment programs with HOPE previously
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
8,949 participants (actual)

Study arms

  • Experimental
    Handwashing

    participants received weekly, in-home handwashing promotion and soap as needed

    Other: handwashing

  • Experimental
    handwashing and water treatment

    Other: handwashing · Other: flocculent-disinfectant for water treatment

  • Experimental
    Water treatment with sodium hypochlorite

    Other: water treatment with sodium hypochlorite

  • Experimental
    Water treatment with flocculent-disinfectant

    participants received a supply of flocculent-disinfectant product and instruction to use it to treat drinking water

    Other: flocculent-disinfectant for water treatment

  • No intervention
    Control

Interventions

  • Otherhandwashing

    participants received weekly in-home handwashing promotion and soap as needed

  • Otherflocculent-disinfectant for water treatment

    participants received a supply of flocculent-disinfectant product for water treatment and instruction in how to use it

  • Otherwater treatment with sodium hypochlorite

    participants received a supply of dilute sodium hypochlorite and instruction to treat drinking water with it

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What researchers measure

Primary outcomes

  1. diarrhea longitudinal prevalence

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Study locations

1 site
  • Health-Oriented Preventive Education
    Karachi, Pakistan
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References and documents

Publications

  • Luby SP, Agboatwalla M, Painter J, Altaf A, Billhimer W, Keswick B, Hoekstra RM. Combining drinking water treatment and hand washing for diarrhoea prevention, a cluster randomised controlled trial. Trop Med Int Health. 2006 Apr;11(4):479-89. doi: 10.1111/j.1365-3156.2006.01592.x. PubMed 16553931 ↗
  • Boudier E, Zurlinden B, Cour A, Rognon M, Devalland-Monnin C, Nirhy-Lanto A, el Khadissi H. [Antenatal diagnosis of achondrogenesis. Two successive cases in the same family]. J Gynecol Obstet Biol Reprod (Paris). 1991;20(5):623-6. French. PubMed 1955657 ↗
  • Bowen A, Agboatwalla M, Luby S, Tobery T, Ayers T, Hoekstra RM. Association between intensive handwashing promotion and child development in Karachi, Pakistan: a cluster randomized controlled trial. Arch Pediatr Adolesc Med. 2012 Nov;166(11):1037-44. doi: 10.1001/archpediatrics.2012.1181. PubMed 22986783 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 27, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01538953
Lead sponsor
Centers for Disease Control and Prevention
Collaborators
Health Oriented Preventive Education, Procter and Gamble
Responsible party
Sponsor
First posted
Feb 27, 2012
Start date
Mar 2003
Primary completion
Dec 2003
Completion
Jan 2004
Last update
Feb 27, 2012

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2012. You cannot join it, but the record below documents what was studied.

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