DiarrheaNCT01538953
Pakistan Flocculent Health Outcome Study
A study testing handwashing, flocculent-disinfectant for water treatment and water treatment with sodium hypochlorite in people with Diarrhea, run by Centers for Disease Control and Prevention at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Diarrhea
- What is being tested?
- handwashing, flocculent-disinfectant for water treatment and water treatment with sodium hypochlorite
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8,949 participants
- Where
- 1 sitePakistan
- Study dates
- Mar 2003to Jan 2004
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- households in study neighborhoods
- contain a child < 5 years old
- have access to water for handwashing
Who cannot join
- participated in handwashing or drinking water treatment programs with HOPE previously
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Diarrhea
- Being tested
- handwashing, flocculent-disinfectant for water treatment, water treatment with sodium hypochlorite
- Keywords
- diarrhea, handwashing, point-of-use water treatment, diarrhea longitudinal prevalence
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
handwashingOther
participants received weekly in-home handwashing promotion and soap as needed
flocculent-disinfectant for water treatmentOther
participants received a supply of flocculent-disinfectant product for water treatment and instruction in how to use it
water treatment with sodium hypochloriteOther
participants received a supply of dilute sodium hypochlorite and instruction to treat drinking water with it
| Study group | Role | What they receive |
|---|---|---|
| Handwashing | Experimental | participants received weekly, in-home handwashing promotion and soap as needed Receives: Other: handwashing |
| handwashing and water treatment | Experimental | Not described Receives: Other: handwashing; Other: flocculent-disinfectant for water treatment |
| Water treatment with sodium hypochlorite | Experimental | Not described Receives: Other: water treatment with sodium hypochlorite |
| Water treatment with flocculent-disinfectant | Experimental | participants received a supply of flocculent-disinfectant product and instruction to use it to treat drinking water Receives: Other: flocculent-disinfectant for water treatment |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
diarrhea longitudinal prevalence
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2012 (estimated)
- Study startMar 2003
- Primary completionDec 2003
- Study completionJan 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DiarrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8,949 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- Health Oriented Preventive Education, Procter and Gamble
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01538953
- Sponsor's protocol ID
- CDC3794
- Status last verified
- Feb 2012
- First submitted
- 21 Feb 2012
- Last updated
- 27 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
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 16553931Boudier 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 1955657Bowen 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
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pakistan Flocculent Health Outcome Study
- ClinicalTrials.gov ID
- NCT01538953
- Acronym / sponsor ID
- CDC3794
- Conditions
- Diarrhea
- Keywords
- diarrhea, handwashing, point-of-use water treatment, diarrhea longitudinal prevalence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8,949 participants (actual)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- Health Oriented Preventive Education, Procter and Gamble
- Study start
- Mar 2003
- Primary completion
- Dec 2003 (actual)
- Study completion
- Jan 2004 (actual)
- First posted
- 27 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Handwashing | Experimental | Other: handwashingparticipants received weekly, in-home handwashing promotion and soap as needed |
| handwashing and water treatment | Experimental | Other: handwashing, Other: flocculent-disinfectant for water treatment |
| Water treatment with sodium hypochlorite | Experimental | Other: water treatment with sodium hypochlorite |
| Water treatment with flocculent-disinfectant | Experimental | Other: flocculent-disinfectant for water treatmentparticipants received a supply of flocculent-disinfectant product and instruction to use it to treat drinking water |
| Control | No intervention | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- households in study neighborhoods
- contain a child < 5 years old
- have access to water for handwashing
Key exclusion criteria (1 listed)
- participated in handwashing or drinking water treatment programs with HOPE previously
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| handwashingparticipants received weekly in-home handwashing promotion and soap as needed | Other | Handwashing, handwashing and water treatment |
| flocculent-disinfectant for water treatmentparticipants received a supply of flocculent-disinfectant product for water treatment and instruction in how to use it | Other | Water treatment with flocculent-disinfectant, handwashing and water treatment |
| water treatment with sodium hypochloriteparticipants received a supply of dilute sodium hypochlorite and instruction to treat drinking water with it | Other | Water treatment with sodium hypochlorite |
Primary outcome
diarrhea longitudinal prevalence
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2012.
- Results publication: PubMed 16553931Luby 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.
- Results publication: PubMed 1955657Boudier 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.
- Derived from this study: PubMed 22986783Bowen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing handwashing, flocculent-disinfectant for water treatment and water treatment with sodium hypochlorite in people with Diarrhea, run by Centers for Disease Control and Prevention at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diarrhea longitudinal prevalence. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01538953, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2012.