Enteric InfectionsNCT03468114
The Safe Start Trial - Kisumu, Kenya
A study testing Safe Start in people with Enteric Infections and Diarrhea, run by London School of Hygiene and Tropical Medicine at 1 site in Kenya.
Trial summary
This a cluster randomised controlled trial (cRCT) to evaluate the effect of a novel food hygiene intervention on infant health. Read more about this study
- Who is it for?
- Ages 21 to 23 weeksHealthy volunteers can take part
- Conditions the study is for
- Enteric Infections, Diarrhea
- What is being tested?
- Safe Start
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 880 participants
- Where
- 1 siteKenya
- Study dates
- 26 Mar 2018to 22 Jun 2019
- 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 21 to 23 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infant is 21-23 weeks of age at enrolment
- Infant's mother residing within catchment of participating health extension worker at time of enrolment and intends to stay in current dwelling at least until infant reaches 37 weeks of age
Who cannot join
- Infant with any medical, psychiatric or social condition which, in the opinion of the research team, impedes the participant's ability to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Safe Start Trial: a Cluster Randomised Controlled Trial for the Effect of a Food Hygiene Intervention on Infant Enteric Infections and Diarrhoeal Disease in Low-income Informal Settlements of Kisumu, Kenya.
This a cluster randomised controlled trial (cRCT) to evaluate the effect of a novel food hygiene intervention on infant health.
Read the detailed description
Enteric infections remain a major threat to child health and development in many low and middle-income countries. Globally, diarrhoeal disease - a key health consequence of enteric infection - is ranked as the fourth leading cause of disability globally, after ischaemic heart disease, lower respiratory tract infections and strokes. Diarrhoeal disease persists as the second leading cause of child deaths in the world, and in sub-Saharan Africa is the leading cause of child deaths.
Public health efforts to address diarrhoeal disease have largely focused on improving access to safe drinking water and sanitation and promoting hand washing with soap to address faecal-oral routes of transmission. These interventions though may not effectively address all exposure pathways during early life, when young children are most susceptible to infection and the diarrhoeal disease burden is greatest. One potentially important exposure pathway is infant food which recent studies conducted in low income, high burden settings suggest may be highly contaminated and may be amenable to simple behaviour change interventions.
The Safe Start trial will evaluate the effect of a novel food hygiene intervention on infant health implemented in low income urban neighbourhoods of Kisumu, Kenya. The intervention is designed to target early childhood exposure to enteric pathogens through contaminated food and was developed through an earlier phase of formative behavioural and microbiological research. The intervention will target infant caregivers and be delivered through the Community Health Volunteer (CHV) health extension system. Four key behaviours will be addressed by the intervention:
- Safe hand hygiene: handwashing with soap before infant food preparation and feeding
- Safe food preparation: bringing all infant food to the boil before feeding, including when reheating
- Safe storage of food: storing all infant food in sealed containers
- Safe feeding: reserving specific feeding utensils for the infant and keeping these separate and clean
A cluster randomized controlled trial (cRCT) design will be used to evaluate the intervention with each CHV catchment area forming one cluster. The outcomes of interest for this study are as follows: (1) the prevalence of enteric infections among infants at 37 weeks of age (primary); (2) the longitudinal prevalence of diarrhoea between 22-37 weeks of age (primary); and (3) incidence of all-cause mortality between 22-37 weeks of age. Infants will be recruited on a rolling basis at 22 weeks of age (+/- 1 week), and data and/or samples collected at 3 points: baseline at 22 weeks of age (+/- 1 week); midline at 33 weeks of age (+/- 1 week); and endline at 37 weeks of age (+/- 1 week). Stool samples will be collected at baseline and endline and analysed for 23 genetic sequences indicating the presence of enteric pathogens known to cause childhood diarrhoea in low income, high burden settings.
- Conditions
- Enteric Infections, Diarrhea
- Being tested
- Safe Start, Active Control
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Safe StartBehavioural
Participant households will receive four visits over a 10 week period from health extension workers promoting safe food preparation, storage and feeding, and will be provided with products to support these practices (a bowl, spoon, cup, hand washing station, liquid soap dispenser).
Active ControlBehavioural
Participant households will receive 4 visits by health extension workers delivering standard care
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participant households will receive 4 visits by health extension workers delivering intervention Receives: Behavioral: Safe Start |
| Control | Active comparator | Participant households will receive 4 visits by health extension workers delivering standard care Receives: Behavioral: Active Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enteric infection prevalence
Enteric infections are defined as the presence of enteric pathogens in stool as indicated by 1 or more of these 23 genetic sequences: Shigella/EIEC virulence plasmid, EAEC_aaic, EAEC_aata, EPEC_eae, EPEC_bfpa, ETEC_LT, ETEC_STp_STh, EHEC Escherichia coli 0157, Aeromonas, Vibrio cholerae, Campylobacter jejuni/C. coli, Clostridium difficile, and Salmonella enterica), Adenovirus 40/41, Adenovirus Hexon, Norovirus GI, Norovirus GII, and Rotavirus and broad reactive Cryptosporidium_18s, C. hominus, C. parvum, and Giardia assemblages A \& B.
Measured: At 37 weeks of age (+/- 1 week)
Diarrhoeal disease longitudinal prevalence
Longitudinal prevalence is defined by days with diarrhoea during follow-up with diarrhoea defined according to WHO definition (3 or more loose or liquid stools passed within 24 hours)
Measured: Between 22 and 37 weeks of age (+/- 1 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2018
- Study start26 Mar 2018
- Primary completion9 May 2019
- Study completion22 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Enteric InfectionsStudies 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
- 880 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Great Lakes University Kisumu, University of Iowa
- Responsible party
- Sponsor
- Investigators
- Oliver Cumming, MSc, Principal investigator, London School of Hygiene and Tropical MedicineJane Mumma, PhD, Principal investigator, Great Lakes University Kisumu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03468114
- Sponsor's protocol ID
- 14695
- Status last verified
- Aug 2019
- First submitted
- 5 Mar 2018
- Last updated
- 21 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Baker KK, Mumma JAO, Simiyu S, Sewell D, Tsai K, Anderson JD, MacDougall A, Dreibelbis R, Cumming O. Environmental and behavioural exposure pathways associated with diarrhoea and enteric pathogen detection in 5-month-old, periurban Kenyan infants: a cross-sectional study. BMJ Open. 2022 Oct 31;12(10):e059878. doi: 10.1136/bmjopen-2021-059878.
PubMed 36316067Mumma J, Simiyu S, Aseyo E, Anderson J, Czerniewska A, Allen E, Dreibelbis R, Baker KK, Cumming O. The Safe Start trial to assess the effect of an infant hygiene intervention on enteric infections and diarrhoea in low-income informal neighbourhoods of Kisumu, Kenya: a study protocol for a cluster randomized controlled trial. BMC Infect Dis. 2019 Dec 19;19(1):1066. doi: 10.1186/s12879-019-4657-0.
PubMed 31856747
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safe Start Trial: a Cluster Randomised Controlled Trial for the Effect of a Food Hygiene Intervention on Infant Enteric Infections and Diarrhoeal Disease in Low-income Informal Settlements of Kisumu, Kenya.
- ClinicalTrials.gov ID
- NCT03468114
- Acronym / sponsor ID
- 14695
- Conditions
- Enteric Infections, Diarrhea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 880 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- Great Lakes University Kisumu, University of Iowa
- Study start
- 26 Mar 2018 (actual)
- Primary completion
- 9 May 2019 (actual)
- Study completion
- 22 Jun 2019 (actual)
- First posted
- 16 Mar 2018 (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.
This a cluster randomised controlled trial (cRCT) to evaluate the effect of a novel food hygiene intervention on infant health.
Detailed description
Enteric infections remain a major threat to child health and development in many low and middle-income countries. Globally, diarrhoeal disease - a key health consequence of enteric infection - is ranked as the fourth leading cause of disability globally, after ischaemic heart disease, lower respiratory tract infections and strokes. Diarrhoeal disease persists as the second leading cause of child deaths in the world, and in sub-Saharan Africa is the leading cause of child deaths.
Public health efforts to address diarrhoeal disease have largely focused on improving access to safe drinking water and sanitation and promoting hand washing with soap to address faecal-oral routes of transmission. These interventions though may not effectively address all exposure pathways during early life, when young children are most susceptible to infection and the diarrhoeal disease burden is greatest. One potentially important exposure pathway is infant food which recent studies conducted in low income, high burden settings suggest may be highly contaminated and may be amenable to simple behaviour change interventions.
The Safe Start trial will evaluate the effect of a novel food hygiene intervention on infant health implemented in low income urban neighbourhoods of Kisumu, Kenya. The intervention is designed to target early childhood exposure to enteric pathogens through contaminated food and was developed through an earlier phase of formative behavioural and microbiological research. The intervention will target infant caregivers and be delivered through the Community Health Volunteer (CHV) health extension system. Four key behaviours will be addressed by the intervention:
- Safe hand hygiene: handwashing with soap before infant food preparation and feeding
- Safe food preparation: bringing all infant food to the boil before feeding, including when reheating
- Safe storage of food: storing all infant food in sealed containers
- Safe feeding: reserving specific feeding utensils for the infant and keeping these separate and clean
A cluster randomized controlled trial (cRCT) design will be used to evaluate the intervention with each CHV catchment area forming one cluster. The outcomes of interest for this study are as follows: (1) the prevalence of enteric infections among infants at 37 weeks of age (primary); (2) the longitudinal prevalence of diarrhoea between 22-37 weeks of age (primary); and (3) incidence of all-cause mortality between 22-37 weeks of age. Infants will be recruited on a rolling basis at 22 weeks of age (+/- 1 week), and data and/or samples collected at 3 points: baseline at 22 weeks of age (+/- 1 week); midline at 33 weeks of age (+/- 1 week); and endline at 37 weeks of age (+/- 1 week). Stool samples will be collected at baseline and endline and analysed for 23 genetic sequences indicating the presence of enteric pathogens known to cause childhood diarrhoea in low income, high burden settings.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Safe StartParticipant households will receive 4 visits by health extension workers delivering intervention |
| Control | Active comparator | Behavioral: Active ControlParticipant households will receive 4 visits by health extension workers delivering standard care |
Who may qualify
- Ages
- 21 to 23 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Infant is 21-23 weeks of age at enrolment
- Infant's mother residing within catchment of participating health extension worker at time of enrolment and intends to stay in current dwelling at least until infant reaches 37 weeks of age
Key exclusion criteria (1 listed)
- Infant with any medical, psychiatric or social condition which, in the opinion of the research team, impedes the participant's ability to give informed consent
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 |
|---|---|---|
| Safe StartParticipant households will receive four visits over a 10 week period from health extension workers promoting safe food preparation, storage and feeding, and will be provided with products to support these practices (a bowl, spoon, cup, hand washing station, liquid soap dispenser). | Behavioural | Intervention |
| Active ControlParticipant households will receive 4 visits by health extension workers delivering standard care | Behavioural | Control |
Primary outcome
Enteric infection prevalence
Time frame: At 37 weeks of age (+/- 1 week)
Enteric infections are defined as the presence of enteric pathogens in stool as indicated by 1 or more of these 23 genetic sequences: Shigella/EIEC virulence plasmid, EAEC_aaic, EAEC_aata, EPEC_eae, EPEC_bfpa, ETEC_LT, ETEC_STp_STh, EHEC Escherichia coli 0157, Aeromonas, Vibrio cholerae, Campylobacter jejuni/C. coli, Clostridium difficile, and Salmonella enterica), Adenovirus 40/41, Adenovirus Hexon, Norovirus GI, Norovirus GII, and Rotavirus and broad reactive Cryptosporidium_18s, C. hominus, C. parvum, and Giardia assemblages A \& B.
Diarrhoeal disease longitudinal prevalence
Time frame: Between 22 and 37 weeks of age (+/- 1 week)
Longitudinal prevalence is defined by days with diarrhoea during follow-up with diarrhoea defined according to WHO definition (3 or more loose or liquid stools passed within 24 hours)
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 21 Aug 2019.
- Derived from this study: PubMed 36316067Baker KK, Mumma JAO, Simiyu S, Sewell D, Tsai K, Anderson JD, MacDougall A, Dreibelbis R, Cumming O. Environmental and behavioural exposure pathways associated with diarrhoea and enteric pathogen detection in 5-month-old, periurban Kenyan infants: a cross-sectional study. BMJ Open. 2022 Oct 31;12(10):e059878. doi: 10.1136/bmjopen-2021-059878.
- Derived from this study: PubMed 31856747Mumma J, Simiyu S, Aseyo E, Anderson J, Czerniewska A, Allen E, Dreibelbis R, Baker KK, Cumming O. The Safe Start trial to assess the effect of an infant hygiene intervention on enteric infections and diarrhoea in low-income informal neighbourhoods of Kisumu, Kenya: a study protocol for a cluster randomized controlled trial. BMC Infect Dis. 2019 Dec 19;19(1):1066. doi: 10.1186/s12879-019-4657-0.
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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.
Oliver Cumming, MSc principal investigator
London School of Hygiene and Tropical Medicine
Jane Mumma, PhD principal investigator
Great Lakes University Kisumu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Safe Start in people with Enteric Infections and Diarrhea, run by London School of Hygiene and Tropical Medicine at 1 site in Kenya.
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 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 21 Aug 2019. 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 Kenya. 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?
Enteric infection prevalence (time frame: At 37 weeks of age (+/- 1 week)). The study lists 2 primary outcomes in all. 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 NCT03468114, which also lists 2 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 21 Aug 2019.