Ascaris Lumbricoides InfectionNCT05372068
Cement flooRs AnD chiLd hEalth (CRADLE)
A study testing Concrete household floor in people with Ascaris Lumbricoides Infection and Necator Americanus Infection, run by Stanford University at 1 site in Bangladesh.
Trial summary
This randomized trial in rural Bangladesh will measure whether installing concrete floors in households with soil floors reduces child enteric infection. The trial will randomize eligible households to receive concrete household floors or to no intervention and measure effects on child soil-transmitted helminth… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Ascaris Lumbricoides Infection, Necator Americanus Infection, Trichuris Trichiura; Infection
- What is being tested?
- Concrete household floor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteBangladesh
- Study dates
- 24 Sep 2023to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Residence in Chauhali upazila or adjacent upazilas in Sirajganj or Tangail districts in Bangladesh
- No plan to relocate in the next 2-3 years
- Reside in home with floors made entirely of soil
- Pregnant woman 13-30 weeks gestation resides in the home at the time of enrollment
Who cannot join
- Home is not strictly residential (e.g., includes a business)
- Household with walls made of mud/soil
- Household floor size > 500 square feet
Trial locations and contacts
1 site in 1 country.
Bangladesh1 site
International Centre for Diarrhoeal Disease Research, Bangladesh
Dhaka
About this study
Official title: Cement flooRs AnD chiLd hEalth (CRADLE): a Randomized Trial in Rural Bangladesh
This randomized trial in rural Bangladesh will measure whether installing concrete floors in households with soil floors reduces child enteric infection. The trial will randomize eligible households to receive concrete household floors or to no intervention and measure effects on child soil-transmitted helminth infection, diarrhea, and other enteric infections. The study will collect longitudinal follow-up measurements at birth and when children are ages 3, 6, 12, 18, and 24 months.
- Conditions
- Ascaris Lumbricoides Infection, Necator Americanus Infection, Trichuris Trichiura; Infection, Diarrhea
- Being tested
- Concrete household floor
- Medical subject headings
- Trichuriasis, Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Concrete household floorOther
Household soil floors will be replaced with concrete floors
| Study group | Role | What they receive |
|---|---|---|
| Concrete household floor | Experimental | Not described Receives: Other: Concrete household floor |
| Non-intervention | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child prevalence of any soil-transmitted helminth infection
Prevalence of Ascaris lumbricoides, Necator americanus, or Trichuris trichiura infection in birth cohort detected with qPCR at 6, 12, 18, or 24 months follow-up
Measured: Up to 24 months
Secondary outcomes (11)
Child Ascaris lumbricoides infection prevalence
Prevalence of Ascaris lumbricoides infection in birth cohort detected with qPCR at 6, 12, 18, or 24 months follow-up
Measured: Up to 24 months
Child Necator americanus infection prevalence
Prevalence of Necator americanus infection in birth cohort detected with qPCR at 6, 12, 18, or 24 months follow-up
Measured: Up to 24 months
Child Trichuris trichiura infection prevalence
Prevalence of Trichuris trichiura infection in birth cohort detected with qPCR at 6, 12, 18, or 24 months follow-up
Measured: Up to 24 months
Child diarrhea prevalence
Prevalence of diarrhea is defined as 3 or more loose or watery stools in 24 hours or 1 or more stools with blood in 24 hours at any follow-up measurement. Diarrhea will be based on caregiver-reported symptoms in the birth cohort with 2-day and 7-day recall at any follow-up measurement through month 24
Measured: Up to 24 months
Ascaris lumbricoides prevalence in household floor samples
Prevalence of Ascaris lumbricoides in household floor dust detected with qPCR in a sub-sample of households at any follow-up measurement (6, 12, 18, 24 months follow-up)
Measured: Up to 24 months
Necator americanus prevalence in household floor samples
Prevalence of Necator americanus detected in household floor dust with qPCR in a sub-sample of households at any follow-up measurement (6, 12, 18, 24 months follow-up)
Measured: Up to 24 months
Trichuris trichiura prevalence in household floor samples
Prevalence of Trichuris trichiura detected in household floor dust with qPCR in a sub-sample of households at any follow-up measurement (6, 12, 18, 24 months follow-up)
Measured: Up to 24 months
Any soil-transmitted helminth prevalence in household floor samples
Prevalence of Ascaris lumbricoides, Necator americanus, or Trichuris trichiura detected in household floor dust with qPCR in a sub-sample of households at any follow-up measurement (6, 12, 18, 24 months follow-up)
Measured: Up to 24 months
Culturable E. coli abundance in household floor samples
Abundance (most probable number per square meter) of E. coli in household floor swabs detected with IDEXX in a sub-sample of households at any follow-up measurement (6, 12, 18, 24 months follow-up)
Measured: Up to 24 months
Culturable E. coli abundance in child hand rinse samples
Abundance (most probable number per two hands) of E. coli on child hands enumerated with IDEXX in a sub-sample of households at any follow-up measurement (6, 12, 18, 24 months follow-up)
Measured: Up to 24 months
Culturable cefotaxime-resistant E. coli prevalence in household floor samples
Prevalence of cefotaxime-resistant E. coli in household floor swabs detected with a modified IDEXX protocol with cefotaxime supplement in a sub-sample of households at any follow-up measurement (6, 12, 18, 24 months follow-up)
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2022
- Study start24 Sep 2023
- Primary completionFeb 2027 (estimated)
- Study completionMay 2027 (estimated)
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 Ascaris Lumbricoides InfectionStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), International Centre for Diarrhoeal Disease Research, Bangladesh, North Carolina State University, Directorate General of Health Services, Bangladesh, Stanford Woods Institute for the Environment
- Responsible party
- Principal investigator, Jade Benjamin-Chung, Stanford University
- Investigators
- Jade Benjamin-Chung, PhD MPH, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05372068
- Sponsor's protocol ID
- 63990
- Other IDs
- R01HD108196
- Status last verified
- Apr 2026
- First submitted
- 6 May 2022
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All human subjects and environmental data will be de-identified and published. Identifiers that will be removed include participant names, address, date of birth, and geocoordinates. Coded data from videos will be made public, but videos will not be published in order to protect participant privacy. All data will be made available at the individual level (or household level, in the case of the household survey).
Publications
Rahman M, Jahan F, Hanif S, Yeamin A, Shoab AK, Andrews JR, Lu Y, Billington S, Pilotte N, Shanta IS, Jubair M, Rahman M, Kabir M, Haque R, Tofail F, Hossain MS, Mahmud ZH, Ercumen A, Benjamin-Chung J. Effects of household concrete floors on maternal and child health: the CRADLE trial - a randomised controlled trial protocol. BMJ Open. 2025 Mar 3;15(3):e090703. doi: 10.1136/bmjopen-2024-090703.
PubMed 40032381Rahman M, Jahan F, Hanif S, Yeamin A, Shoab AK, Andrews JR, Lu Y, Billington S, Pilotte N, Shanta IS, Jubair M, Rahman M, Kabir M, Haque R, Tofail F, Hossain S, Mahmud ZH, Ercumen A, Benjamin-Chung J. Effects of household concrete floors on maternal and child health - the CRADLE trial: a randomised controlled trial protocol. medRxiv [Preprint]. 2024 Jul 27:2024.07.26.24311076. doi: 10.1101/2024.07.26.24311076.
PubMed 39108529
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cement flooRs AnD chiLd hEalth (CRADLE): a Randomized Trial in Rural Bangladesh
- ClinicalTrials.gov ID
- NCT05372068
- Acronym / sponsor ID
- 63990
- Conditions
- Ascaris Lumbricoides Infection, Necator Americanus Infection, Trichuris Trichiura; Infection, Diarrhea
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), International Centre for Diarrhoeal Disease Research, Bangladesh, North Carolina State University, Directorate General of Health Services, Bangladesh, Stanford Woods Institute for the Environment
- Study start
- 24 Sep 2023 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 12 May 2022 (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 randomized trial in rural Bangladesh will measure whether installing concrete floors in households with soil floors reduces child enteric infection. The trial will randomize eligible households to receive concrete household floors or to no intervention and measure effects on child soil-transmitted helminth infection, diarrhea, and other enteric infections. The study will collect longitudinal follow-up measurements at birth and when children are ages 3, 6, 12, 18, and 24 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Concrete household floor | Experimental | Other: Concrete household floor |
| Non-intervention | No intervention | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Residence in Chauhali upazila or adjacent upazilas in Sirajganj or Tangail districts in Bangladesh
- No plan to relocate in the next 2-3 years
- Reside in home with floors made entirely of soil
- Pregnant woman 13-30 weeks gestation resides in the home at the time of enrollment
Key exclusion criteria (3 listed)
- Home is not strictly residential (e.g., includes a business)
- Household with walls made of mud/soil
- Household floor size > 500 square feet
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 |
|---|---|---|
| Concrete household floorHousehold soil floors will be replaced with concrete floors | Other | Concrete household floor |
Primary outcome
Child prevalence of any soil-transmitted helminth infection
Time frame: Up to 24 months
Prevalence of Ascaris lumbricoides, Necator americanus, or Trichuris trichiura infection in birth cohort detected with qPCR at 6, 12, 18, or 24 months follow-up
11 secondary outcomes
Child Ascaris lumbricoides infection prevalence
Time frame: Up to 24 months
Child Necator americanus infection prevalence
Time frame: Up to 24 months
Child Trichuris trichiura infection prevalence
Time frame: Up to 24 months
Child diarrhea prevalence
Time frame: Up to 24 months
Ascaris lumbricoides prevalence in household floor samples
Time frame: Up to 24 months
Necator americanus prevalence in household floor samples
Time frame: Up to 24 months
Trichuris trichiura prevalence in household floor samples
Time frame: Up to 24 months
Any soil-transmitted helminth prevalence in household floor samples
Time frame: Up to 24 months
Culturable E. coli abundance in household floor samples
Time frame: Up to 24 months
Culturable E. coli abundance in child hand rinse samples
Time frame: Up to 24 months
Culturable cefotaxime-resistant E. coli prevalence in household floor samples
Time frame: Up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Derived from this study: PubMed 40032381Rahman M, Jahan F, Hanif S, Yeamin A, Shoab AK, Andrews JR, Lu Y, Billington S, Pilotte N, Shanta IS, Jubair M, Rahman M, Kabir M, Haque R, Tofail F, Hossain MS, Mahmud ZH, Ercumen A, Benjamin-Chung J. Effects of household concrete floors on maternal and child health: the CRADLE trial - a randomised controlled trial protocol. BMJ Open. 2025 Mar 3;15(3):e090703. doi: 10.1136/bmjopen-2024-090703.
- Derived from this study: PubMed 39108529Rahman M, Jahan F, Hanif S, Yeamin A, Shoab AK, Andrews JR, Lu Y, Billington S, Pilotte N, Shanta IS, Jubair M, Rahman M, Kabir M, Haque R, Tofail F, Hossain S, Mahmud ZH, Ercumen A, Benjamin-Chung J. Effects of household concrete floors on maternal and child health - the CRADLE trial: a randomised controlled trial protocol. medRxiv [Preprint]. 2024 Jul 27:2024.07.26.24311076. doi: 10.1101/2024.07.26.24311076.
- Individual participant dataSharing planned: Yes. All human subjects and environmental data will be de-identified and published. Identifiers that will be removed include participant names, address, date of birth, and geocoordinates. Coded data from videos will be made public, but videos will not be published in order to protect participant privacy. All data will be made available at the individual level (or household level, in the case of the household survey).
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RecruitingPhase 4
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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.
Jade Benjamin-Chung, PhD MPH principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Concrete household floor in people with Ascaris Lumbricoides Infection and Necator Americanus Infection, run by Stanford University at 1 site in Bangladesh.
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 4 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 28 Apr 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 Bangladesh. 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?
This study is still under way. Results are not available in the source record yet.
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?
Child prevalence of any soil-transmitted helminth infection (time frame: Up to 24 months). 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 NCT05372068, 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 28 Apr 2026; AzTrials last refreshed its copy on 7 Nov 2026.