NCT07158632

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
840

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 22, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

September 8, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

September 8, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2025

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 24, 2025

Completed
Last Updated

September 9, 2025

Status Verified

September 1, 2025

Enrollment Period

3 months

First QC Date

August 22, 2025

Last Update Submit

September 6, 2025

Conditions

Keywords

central Ethiopia, Diarrhea, Ethiopia, Multiple Interventions

Outcome Measures

Primary Outcomes (1)

  • Incidence of diarrhea among under-five children

    At baseline and to four-month follow-up

Secondary Outcomes (1)

  • Adherence of interventions

    Up to four-month follow-up

Study Arms (4)

handwashing education only arm

EXPERIMENTAL

Arm A: This arm receives handwashing education.

Behavioral: handwashing education

water chlorination only arm

EXPERIMENTAL

Arm B: This arm receives household water chlorination

Behavioral: water chlorination

combined hand washing and water chlorination arm

EXPERIMENTAL

Arm C: This arm receives both handwashing education and water chlorination.

Behavioral: combined intervention

No intervention arm

NO INTERVENTION

This arm have not receive any intervention

Interventions

Arm A: This arm receive handwashing education using social and behavioral change communication

handwashing education only arm

Arm B: This arm receives water chlorination intervention

water chlorination only arm

Arm C: This arm receives combined handwashing and water chlorination intervention

combined hand washing and water chlorination arm

Eligibility Criteria

Age6 Months - 59 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may not qualify if:

  • severely ill mother, households that receive treated water

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Butajira Health Center

Butajīra, Ethiopia

Location

Related Publications (1)

  • 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

    BACKGROUND

MeSH Terms

Conditions

Diarrhea

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Melaku Tesfaye PhD Candidate, MPH

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Model Details: The study contains four arms; these are handwashing education arm, water chlorination arm, combination arm, and control arm
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Candidate

Study Record Dates

First Submitted

August 22, 2025

First Posted

September 8, 2025

Study Start

September 8, 2025

Primary Completion

December 10, 2025

Study Completion

December 24, 2025

Last Updated

September 9, 2025

Record last verified: 2025-09

Locations