Diarrheal DiseasesNCT07158632
Effects of Multiple Interventions on Under-Five Diarrhea
A study testing handwashing education, water chlorination and combined intervention in people with Diarrheal Diseases, run by Jimma University at 1 site in Ethiopia.
Trial summary
Diarrhea is the leading cause of death, especially in developed nations. Though there are effective interventions, diarrhea remains the leading cause of death among children in Ethiopia Read more about this study
- Who is it for?
- Ages 6 to 59 months
- Conditions the study is for
- Diarrheal Diseases
- What is being tested?
- handwashing education, water chlorination and combined intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 835 participants
- Where
- 1 siteEthiopia
- Study dates
- 11 Sep 2025to 19 Feb 2026
- 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 6 to 59 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- a child age from 6 to 59 months Exclusion Criteria
- child with persistent diarrhea, severely ill mother, households that receive treated water
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Maternal Handwashing Education and Household Water Chlorination on Diarrheal Disease Among Under-Five Children in Central Ethiopia Using RCT
Diarrhea is the leading cause of death, especially in developed nations. Though there are effective interventions, diarrhea remains the leading cause of death among children in Ethiopia
Read the detailed description
Diarrheal disease is the major cause of child morbidity and mortality in low-income countries, including Ethiopia. Diarrhea is more common in areas with a lack of water sanitation and hygiene. Even though there are available effective interventions, diarrhea remains the major cause of child morbidity and mortality in Ethiopia. Therefore, the aim of this study is to give up-to-date information on multiple interventions that reduce diarrheal disease.
- Conditions
- Diarrheal Diseases
- Being tested
- handwashing education, water chlorination, combined intervention
- Keywords
- central Ethiopia, Diarrhea, Ethiopia, Multiple Interventions
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
handwashing educationBehavioural
Arm A: This arm receive handwashing education using social and behavioral change communication
water chlorinationBehavioural
Arm B: This arm receives water chlorination intervention
combined interventionBehavioural
Arm C: This arm receives combined handwashing and water chlorination intervention
| Study group | Role | What they receive |
|---|---|---|
| handwashing education only arm | Experimental | Arm A: This arm receives handwashing education. Receives: Behavioral: handwashing education |
| water chlorination only arm | Experimental | Arm B: This arm receives household water chlorination Receives: Behavioral: water chlorination |
| combined hand washing and water chlorination arm | Experimental | Arm C: This arm receives both handwashing education and water chlorination. Receives: Behavioral: combined intervention |
| No intervention arm | No intervention | This arm have not receive any intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of diarrhea among under-five children
Measured: At baseline and to four-month follow-up
Secondary outcomes (1)
Adherence of interventions
percentage of soap availability near toilet and residual chlorine in drinking water
Measured: Up to four-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start11 Sep 2025
- Primary completion12 Feb 2026
- Study completion19 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diarrheal DiseasesStudies 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
- Factorial
- Model description
- The study contains four arms; these are handwashing education arm, water chlorination arm, combination arm, and control arm
- Masking
- None (open label)
- Enrolment
- 835 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jimma University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melaku Tesfaye, Jimma University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07158632
- Sponsor's protocol ID
- JUIH/IRB/0509/25
- Status last verified
- May 2026
- First submitted
- 22 Aug 2025
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Breastfeeding and protection against diarrhea: an integrative review of literature Aleitamento materno e proteção contra diarreia: revisão integrativa da literatura Floriacy Stabnow Santos1 , Felipe César Stabnow Santos2 Adriana Moraes Leite1 , Leonardo Hunaldo dos Santos3 , Débora Falleiros de Mello1
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Maternal Handwashing Education and Household Water Chlorination on Diarrheal Disease Among Under-Five Children in Central Ethiopia Using RCT
- ClinicalTrials.gov ID
- NCT07158632
- Acronym / sponsor ID
- JUIH/IRB/0509/25
- Conditions
- Diarrheal Diseases
- Keywords
- central Ethiopia, Diarrhea, Ethiopia, Multiple Interventions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 835 participants (actual)
- Lead sponsor
- Jimma UniversityUniversity, hospital or other
- Study start
- 11 Sep 2025 (actual)
- Primary completion
- 12 Feb 2026 (actual)
- Study completion
- 19 Feb 2026 (actual)
- First posted
- 8 Sep 2025 (actual)
- 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.
Diarrhea is the leading cause of death, especially in developed nations. Though there are effective interventions, diarrhea remains the leading cause of death among children in Ethiopia
Detailed description
Diarrheal disease is the major cause of child morbidity and mortality in low-income countries, including Ethiopia. Diarrhea is more common in areas with a lack of water sanitation and hygiene. Even though there are available effective interventions, diarrhea remains the major cause of child morbidity and mortality in Ethiopia. Therefore, the aim of this study is to give up-to-date information on multiple interventions that reduce diarrheal disease.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- The study contains four arms; these are handwashing education arm, water chlorination arm, combination arm, and control arm
| Arm | Type | Receives |
|---|---|---|
| handwashing education only arm | Experimental | Behavioral: handwashing educationArm A: This arm receives handwashing education. |
| water chlorination only arm | Experimental | Behavioral: water chlorinationArm B: This arm receives household water chlorination |
| combined hand washing and water chlorination arm | Experimental | Behavioral: combined interventionArm C: This arm receives both handwashing education and water chlorination. |
| No intervention arm | No intervention | –This arm have not receive any intervention |
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- a child age from 6 to 59 months Exclusion Criteria
- child with persistent diarrhea, severely ill mother, households that receive treated water
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| handwashing educationArm A: This arm receive handwashing education using social and behavioral change communication | Behavioural | handwashing education only arm |
| water chlorinationArm B: This arm receives water chlorination intervention | Behavioural | water chlorination only arm |
| combined interventionArm C: This arm receives combined handwashing and water chlorination intervention | Behavioural | combined hand washing and water chlorination arm |
Primary outcome
Incidence of diarrhea among under-five children
Time frame: At baseline and to four-month follow-up
1 secondary outcome
Adherence of interventions
Time frame: Up to four-month follow-up
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 8 May 2026.
- Results publicationBreastfeeding and protection against diarrhea: an integrative review of literature Aleitamento materno e proteção contra diarreia: revisão integrativa da literatura Floriacy Stabnow Santos1 , Felipe César Stabnow Santos2 Adriana Moraes Leite1 , Leonardo Hunaldo dos Santos3 , Débora Falleiros de Mello1
- Individual participant dataSharing planned: Undecided
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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 education, water chlorination and combined intervention in people with Diarrheal Diseases, run by Jimma University at 1 site in Ethiopia.
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 2 inclusion and 0 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 8 May 2026. 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 Ethiopia. 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?
Incidence of diarrhea among under-five children (time frame: At baseline and to four-month follow-up). 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 NCT07158632, which also lists 1 linked publication.
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 8 May 2026.