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Active, not recruitingNCT05372068Updated Apr 28, 2026

Cement flooRs AnD chiLd hEalth (CRADLE)

An interventional study of Concrete household floor in Ascaris Lumbricoides Infection, Necator Americanus Infection and Trichuris Trichiura; Infection, sponsored by Stanford University. Active, not recruiting at 1 site in Bangladesh. Per ClinicalTrials.gov, last updated 2026-04-28.

Sponsored by Stanford University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
800
Allocation
Randomized
Sex
All
01

Study 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 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.

02

Conditions studied

  • Ascaris Lumbricoides Infection
  • Necator Americanus Infection
  • Trichuris Trichiura; Infection
  • Diarrhea
03

In context

Trichuriasis

30 studies on the registry are indexed under Trichuriasis; 7 are open to participants now.

This study's planned enrollment of 800 is above the median of 315 across 27 interventional studies indexed under Trichuriasis.

Browse Trichuriasis studies →

Lead sponsor

Stanford University is the lead sponsor of 2,168 studies on the registry; 431 are open to participants now.

Of its 267 completed or terminated interventional studies of FDA-regulated products, 207 (78%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Home is not strictly residential (e.g., includes a business)
  • Household with walls made of mud/soil
  • Household floor size > 500 square feet
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
800 participants (estimated)

Study arms

  • Experimental
    Concrete household floor

    Other: Concrete household floor

  • No intervention
    Non-intervention

Interventions

  • OtherConcrete household floor

    Household soil floors will be replaced with concrete floors

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What researchers measure

Primary outcomes

  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

    Time frame: Up to 24 months

Secondary outcomes

  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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: Up to 24 months

07

Study locations

1 site
08

References and documents

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 ↗

Individual participant data

Plan to share: 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).

Supporting information: Study protocol, Statistical analysis plan, Analytic code

Time frame: De-identified data will be made publicly available within 2 years of the end of the study or at the time of publication, whichever is sooner.

Access criteria: To be determined

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05372068
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
Jade Benjamin-Chung (Assistant Professor of Epidemiology & Population Health, Stanford University) — Principal investigator
First posted
May 12, 2022
Start date
Sep 24, 2023
Primary completion
Feb 2027 (estimated)
Completion
May 2027 (estimated)
Last update
Apr 28, 2026

Study contacts

Jade Benjamin-Chung, PhD MPH
principal investigator · Stanford University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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