DiarrheaNCT04580212
Poultry Management and Child Diarrhea in Uganda
A study testing Poultry hygiene intervention in people with Diarrhea, run by North Carolina State University at 1 site in Uganda.
Trial summary
Fecal contamination from animal sources, specifically chickens, is increasingly recognized as a risk factor for enteric infections in low-income countries where domestic animals are often kept in close proximity to living quarters. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diarrhea
- What is being tested?
- Poultry hygiene intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,307 participants
- Where
- 1 siteUganda
- Study dates
- 1 Sep 2019to 25 Aug 2021
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least one person in the household is a member of Self-Help Groups formed by The Water Trust, Uganda
- There is at least one child under the age of 5 years living in the household
- There is an adult (>18 years) primary caregiver of a child <5 years available for participation in study
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Hygienic Management of Poultry in Rural Uganda
Fecal contamination from animal sources, specifically chickens, is increasingly recognized as a risk factor for enteric infections in low-income countries where domestic animals are often kept in close proximity to living quarters. Community members typically allow chickens to move freely around their compound and in their homes. Unlike other animals, such as cows or goats, poultry are typically not confined and their feces, which are relatively small, are considered relatively innocuous and therefore largely ignored by adults and children. In this study, the investigators have implemented an intervention to help rural poultry owners with children to hygienically separate chickens from children by focusing on a small set of key factors, including increased risk perception, increased perception of potential livelihood benefits, increased skills, and increased supportive social norms. The investigators hypothesized that the poultry hygiene intervention will lead to improved poultry management practices, which will in turn lead to reduced fecal contamination in the domestic environment and subsequently reduced diarrheal illness in young children. To measure these parameters along the causal chain, the investigators used a combination of household surveys, spot check observations and testing of environmental samples for fecal contamination.
- Conditions
- Diarrhea
- Being tested
- Poultry hygiene intervention
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Poultry hygiene interventionBehavioural
The intervention will consist of a series of participatory training exercises designed to accomplish three main goals: (1) increase awareness of health risks and lost livelihood benefits of current poultry management practices, (2) build practical skills for poultry management, and (3) build supportive community norms by facilitating savings group discussions on poultry management. The intervention will be delivered through three activities: (1) triggering exercise designed to raise awareness of both the health risks of the current practices and the economic potential of a more active poultry management approach, and ultimately to motivate participants for behavior change, (2) poultry management training activity based on local needs and norms, and (3) periodic follow-on coaching to reinforce messages from the initial training and emphasize action planning, monitoring of plan execution, and troubleshooting.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | This arm received the poultry hygiene intervention. Receives: Behavioral: Poultry hygiene intervention |
| Control arm | No intervention | This arm received no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of children <5 years with caregiver-reported diarrhea in past 7 days
Diarrhea defined as 3 or more soft or watery stools in 24-hour period
Measured: Caregiver reported 7-day prevalence of diarrhea in children <5 years, measured approximately 1 year after initiation of intervention
Secondary outcomes (2)
Proportion of households with E.coli in household environmental samples
Detection of E. coli (general fecal indicator)
Measured: Ascertained with analysis of samples from households, collected approximately 1 year after initiation of intervention
Proportion of households with observed poultry feces in compound
Poultry feces occurrences observed in household compounds
Measured: Ascertained by spot check observation approximately 1 year after initiation of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start1 Sep 2019
- Primary completion25 Aug 2021
- Study completion25 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 1,307 participants (actual)
Sponsor and investigators
- Lead sponsor
- North Carolina State University
- Sponsor type
- University, hospital or other
- Collaborators
- The Water Trust
- Responsible party
- Principal investigator, Ayse Ercumen, North Carolina State University
- Investigators
- Ayse Ercumen, Principal investigator, North Carolina State UniversityAngela Harris, Principal investigator, North Carolina State UniversityChris Prottas, Study director, The Water Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04580212
- Sponsor's protocol ID
- 698
- Status last verified
- Mar 2022
- First submitted
- 2 Oct 2020
- Last updated
- 23 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Hygienic Management of Poultry in Rural Uganda
- ClinicalTrials.gov ID
- NCT04580212
- Acronym / sponsor ID
- 698
- Conditions
- Diarrhea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,307 participants (actual)
- Lead sponsor
- North Carolina State UniversityUniversity, hospital or other
- Collaborators
- The Water Trust
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 25 Aug 2021 (actual)
- Study completion
- 25 Aug 2021 (actual)
- First posted
- 8 Oct 2020 (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.
Fecal contamination from animal sources, specifically chickens, is increasingly recognized as a risk factor for enteric infections in low-income countries where domestic animals are often kept in close proximity to living quarters. Community members typically allow chickens to move freely around their compound and in their homes. Unlike other animals, such as cows or goats, poultry are typically not confined and their feces, which are relatively small, are considered relatively innocuous and therefore largely ignored by adults and children. In this study, the investigators have implemented an intervention to help rural poultry owners with children to hygienically separate chickens from children by focusing on a small set of key factors, including increased risk perception, increased perception of potential livelihood benefits, increased skills, and increased supportive social norms. The investigators hypothesized that the poultry hygiene intervention will lead to improved poultry management practices, which will in turn lead to reduced fecal contamination in the domestic environment and subsequently reduced diarrheal illness in young children. To measure these parameters along the causal chain, the investigators used a combination of household surveys, spot check observations and testing of environmental samples for fecal contamination.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Behavioral: Poultry hygiene interventionThis arm received the poultry hygiene intervention. |
| Control arm | No intervention | –This arm received no intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- At least one person in the household is a member of Self-Help Groups formed by The Water Trust, Uganda
- There is at least one child under the age of 5 years living in the household
- There is an adult (>18 years) primary caregiver of a child <5 years available for participation in study
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Poultry hygiene interventionThe intervention will consist of a series of participatory training exercises designed to accomplish three main goals: (1) increase awareness of health risks and lost livelihood benefits of current poultry management practices, (2) build practical skills for poultry management, and (3) build supportive community norms by facilitating savings group discussions on poultry management. The intervention will be delivered through three activities: (1) triggering exercise designed to raise awareness of both the health risks of the current practices and the economic potential of a more active poultry management approach, and ultimately to motivate participants for behavior change, (2) poultry management training activity based on local needs and norms, and (3) periodic follow-on coaching to reinforce messages from the initial training and emphasize action planning, monitoring of plan execution, and troubleshooting. | Behavioural | Intervention arm |
Primary outcome
Prevalence of children <5 years with caregiver-reported diarrhea in past 7 days
Time frame: Caregiver reported 7-day prevalence of diarrhea in children <5 years, measured approximately 1 year after initiation of intervention
Diarrhea defined as 3 or more soft or watery stools in 24-hour period
2 secondary outcomes
Proportion of households with E.coli in household environmental samples
Time frame: Ascertained with analysis of samples from households, collected approximately 1 year after initiation of intervention
Proportion of households with observed poultry feces in compound
Time frame: Ascertained by spot check observation approximately 1 year after initiation of intervention
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 23 Mar 2022.
Related trials for Diarrhea
RecruitingPhase 2
Long-Term Immunogenicity of the altSonflex1-2-3 Shigella Vaccine in African Children
Diarrhoea
RecruitingPhase 2
Prophylactic Mesalamine to Prevent Colitis Following Treatment With Ipilimumab/Nivolumab (Ipi/Nivo)
Immune-related Adverse Event, Diarrhea
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)
Irritable Bowel Syndrome, Diarrhea
Recruiting
Lactic Acid Bacteria in Functional Diarrheal Disorders
IBS-D (Diarrhea-predominant), IBS (Irritable Bowel Syndrome)
RecruitingPhase 3
VE303 for Prevention of Recurrent Clostridioides Difficile Infection
Clostridium Difficile, Clostridium Difficile Infections
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.
Ayse Ercumen principal investigator
North Carolina State University
Angela Harris principal investigator
North Carolina State University
Chris Prottas study director
The Water Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Poultry hygiene intervention in people with Diarrhea, run by North Carolina State University at 1 site in Uganda.
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 23 Mar 2022. 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 Uganda. 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?
Prevalence of children <5 years with caregiver-reported diarrhea in past 7 days (time frame: Caregiver reported 7-day prevalence of diarrhea in children <5 years, measured approximately 1 year after initiation of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Mar 2022.