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Active, Not Recruiting

NCT Number: NCT05372068

Cement flooRs AnD chiLd hEalth (CRADLE)

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Ascaris Lumbricoides Infection Adenophorea Infections Diarrhea Enoplida Infections Helminthiasis Infections Necator Americanus Infection Nematode Infections Parasitic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Trichuriasis Trichuris Trichiura; Infection

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

International Centre for Diarrhoeal Disease Research, Bangladesh

Dhaka, Bangladesh

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Concrete household floor

Other

Household soil floors will be replaced with concrete floors

Primary outcomes

  1. 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

Secondary outcomes

  1. Child Ascaris lumbricoides infection prevalence

    Time frame: Up to 24 months

    Prevalence of Ascaris lumbricoides infection in birth cohort detected with qPCR at 6, 12, 18, or 24 months follow-up

  2. Child Necator americanus infection prevalence

    Time frame: Up to 24 months

    Prevalence of Necator americanus infection in birth cohort detected with qPCR at 6, 12, 18, or 24 months follow-up

  3. Child Trichuris trichiura infection prevalence

    Time frame: Up to 24 months

    Prevalence of Trichuris trichiura infection in birth cohort detected with qPCR at 6, 12, 18, or 24 months follow-up

  4. Child diarrhea prevalence

    Time frame: Up to 24 months

    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

  5. Ascaris lumbricoides prevalence in household floor samples

    Time frame: Up to 24 months

    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)

  6. Necator americanus prevalence in household floor samples

    Time frame: Up to 24 months

    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)

  7. Trichuris trichiura prevalence in household floor samples

    Time frame: Up to 24 months

    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)

  8. Any soil-transmitted helminth prevalence in household floor samples

    Time frame: Up to 24 months

    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)

  9. Culturable E. coli abundance in household floor samples

    Time frame: Up to 24 months

    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)

  10. Culturable E. coli abundance in child hand rinse samples

    Time frame: Up to 24 months

    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)

  11. Culturable cefotaxime-resistant E. coli prevalence in household floor samples

    Time frame: Up to 24 months

    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)

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Directorate General of Health Services, Bangladesh
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • International Centre for Diarrhoeal Disease Research, Bangladesh
  • North Carolina State University
  • Stanford Woods Institute for the Environment

Registry information

Official study title

Cement flooRs AnD chiLd hEalth (CRADLE): a Randomized Trial in Rural Bangladesh

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
May 12, 2022
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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