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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.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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
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

Other trials in Bangladesh

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.

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 groups in NCT05372068
Study groupRoleWhat they receive
Concrete household floorExperimentalNot described
Receives: Other: Concrete household floor
Non-interventionNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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.

  1. First posted12 May 2022
  2. Study start24 Sep 2023
  3. Primary completionFeb 2027 (estimated)
  4. Study completionMay 2027 (estimated)

Resources

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)
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 40032381

  • 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 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

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.

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