MalnutritionNCT01590095
WASH Benefits Bangladesh
A study testing Water quality, Sanitation and Hand washing in people with Malnutrition and Diarrhea, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 1 site in Bangladesh.
Trial summary
Brief Summary: The purpose of this study is to measure the independent and combined effects of interventions that improve water quality, sanitation, hand washing, and nutrition on child growth and development in the first years of life. Read more about this study
- Who is it for?
- Ages 1 day to 63 yearsHealthy volunteers can take part
- Conditions the study is for
- Malnutrition, Diarrhea, Child Development
- What is being tested?
- Water quality, Sanitation and Hand washing
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,040 participants
- Where
- 1 siteBangladesh
- Study dates
- May 2012to Dec 2022
- 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 1 day to 63 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Infants (target child) will be eligible to participate in the study if they are:
- They are in utero at the baseline survey
- Their parents/guardians are planning to stay in the study village for the next 12 months (if a mother is planning to give birth at her natal home and then return, she will still be a candidate for enrollment)
- Children < 36 months old at baseline that are living in the compound of a target child will be eligible to participate in diarrhea measurement if:
- They are < 36 months old at the baseline survey
- Their parents/guardians are planning to stay in the study village for the next 12 months
Show all 9Show fewer
- Children 18 - 27 months old at baseline that are living in the compound of a target child will be eligible to participate in intestinal parasite specimen collection if:
- They are 18 - 27 months old at the baseline survey
- Their parents/guardians are planning to stay in the study village for the next 12 months
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: WASH Benefits Bangladesh: A Cluster Randomized Controlled Trial of the Benefits of Water, Sanitation, Hygiene Plus Nutrition Interventions on Child Growth
Brief Summary:
The purpose of this study is to measure the independent and combined effects of interventions that improve water quality, sanitation, hand washing, and nutrition on child growth and development in the first years of life.
Read the detailed description
Detailed Description:
Infection and inadequate diet are proximate risk factors for under-nutrition and early life growth faltering; the two processes likely act reciprocally in a vicious cycle that perpetuates physiologic and metabolic deficits and increases the risk of mortality. Children who exhibit growth faltering are more likely to have deficits in cognitive development and long-term human capital, and are more likely to have children who also suffer from growth deficits - perpetuating the cycle into the next generation.
There are two probable interdependent pathways that link enteric infections to child growth and development. The first pathway includes repeated infections the lead to acute illness or parasitic infection in the first years of life, which increase the risk of stunting and subsequent cognitive deficits in childhood and later in life. The second pathway is through a subclinical condition called environmental enteropathy (EE).
There is limited evidence to demonstrate whether or not water quality, sanitation, and hand washing (WASH) interventions can improve measures of EE, child growth and development, and whether nutritional interventions could be enhanced if provided concurrently with WASH interventions. To help fill this evidence gap, the WASH Benefits study will deliver randomized interventions designed to reduce infection and improve nutrition, and will measure intervention effects on child illness, growth and development. WASH Benefits includes two, comparable but standalone trials in Bangladesh and Kenya that are registered under separate protocols.
In Bangladesh, the study will include 720 clusters, and each cluster will enroll 8 household compounds (baris) with pregnant women in their second or third trimester. The study will randomize 90 clusters to each of 6 active intervention arms (water quality, sanitation, hand washing, combined WSH, nutrition, nutrition+WSH), and 180 clusters to a standard practices non-intervention arm. Children born into the cohort will be followed for 2 years after the intervention, with measurements at 12 and 24 months after intervention delivery. (anticipated age range: 20 - 27 months old at the final measurement). At the 12- and 24-month follow-up visits, the study will collect child anthropometric measurements and caregiver-reported diarrhea. In the final visit the study will administer a test to measure child development outcomes. The study will collect urine, blood, and stool specimens from a subsample of 1,500 children distributed across four arms of the study (Control, combined WSH, Nutrition, Nutrition+WSH) to measure biomarkers of gut function and intestinal parasitic infections at the 12- and 24-month follow-up visits. In addition, the study will collect specimens (blood, stool) from children 18 - 27 months old at baseline who are living in the same compound as target children to test for intestinal parasitic infections. At 24-months in all arms, the study will collect specimens stool from target children, children 18 - 27 months old at baseline, a school-aged child, and an adult who are living in the same compound as target children to test for intestinal parasitic infections. At 36-months in all arms, the study will collect specimens stool from target children, a school-aged child, and an adult who are living in the same compound as target children to test for intestinal parasitic infections.
- Conditions
- Malnutrition, Diarrhea, Child Development
- Being tested
- Water quality, Sanitation, Hand washing, Water quality, Sanitation, Hand washing (Combined WASH), Nutrition
- Keywords
- Chlorine water treatment, Point-of-use water treatment, Household water treatment with safe storage, Hand washing with soap, Hand hygiene, Latrines, Child potties, Point-of-use fortification, Lipid-based nutrient supplement, Environmental enteropathy, Tropical enteropathy, Gut function, Intestinal parasitic infection, Soil transmitted helminths, Intestinal protozoans, Antibody response, Water, Sanitation, Hand washing, Breast Feeding
- Medical subject headings
- Malnutrition, Diarrhea, Sprue, Tropical, Intestinal Diseases, Parasitic, Breast Feeding, Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Water qualityBehavioural
Hardware: Free supplies chlorine tablets (Aquatabs; NaDCC) and a safe storage vessel to treat and store drinking water.
Promotion: Local promoters will visit study compounds at least monthly to deliver behavior change messages that focus on the treatment of all drinking water for children < 36 months of age.
SanitationBehavioural
Hardware: Free child potties, sani-scoop hoes to remove feces from household environments, latrine upgrades to a dual pit latrine Promotion: Local promoters will visit study compounds at least monthly to deliver behavior change messages that focus on the use of latrines for defecation and the removal of human and animal feces from the compound.
Hand washingBehavioural
Hardware: Hand washing stations, soapy water bottles located at hand washing locations, detergent soap to supply soapy water bottles.
Promotion: Local promoters will visit study compounds at least monthly to deliver behavior change messages that focus on hand washing with soap at critical times around food preparation, defecation, and contact with feces.
Water quality, Sanitation, Hand washing (Combined WASH)Behavioural
Hardware: Free supplies Aquatabs; (NaDCC) and a safe storage vessel to treat and store drinking water. Promotion: Local promoters will visit study compounds at least monthly to deliver behavior change messages that focus on the treatment of all drinking water for children < 36 months of age.
Hardware: Free child potties, sani-scoop hoes to remove feces from household environments, latrine upgrades to a dual pit latrine. Promotion: Local promoters will visit study compounds at least monthly to deliver behavior change messages that focus on the use of latrines for defecation and the removal of human and animal feces from the compound.
Hardware: Hand washing stations, soapy water bottles located at hand washing locations, detergent soap to supply soapy water bottles. Promotion: Local promoters will visit study compounds at least monthly to deliver behavior change messages that focus on hand washing with soap at critical times around food preparation, defecation, and contact with feces.
NutritionBehavioural
Supplement: Lipid-based Nutrient Supplement (LNS) delivered daily from ages 6 to 24 months.
Promotion: Local promoters will visit study compounds at least monthly to deliver behavior change messages modeled on those recommended in the Guiding Principles for Complementary Feeding of the Breastfed Child and the recent UNICEF Program Guide for Infant and Young Child Feeding Practices.General messages will include (1) practice exclusive breastfeeding from birth to 6 months of age and introduce complementary foods at 6 months of age while continuing to breastfeed; (2) continue breast feeding as you did before receiving LNS; (3) provide your child micronutrient-rich foods such as meat, fish, eggs, and vitamin A rich fruits and vegetables; and (4) feed your child at least 2-3 times per day when 6-8 months old and 3-4 times per day when 9-24 months old.
Nutrition, Water quality, Sanitation, Hand washingBehavioural
Each of the interventions described above for Water Quality, Sanitation \& Hand washing (Combined WASH) Plus the intervention described above for nutrition.
| Study group | Role | What they receive |
|---|---|---|
| Water quality | Active comparator | 90 clusters, approx. 720 newborns Receives: Behavioral: Water quality |
| Sanitation | Active comparator | 90 clusters, approx. 720 newborns Receives: Behavioral: Sanitation |
| Hand washing | Active comparator | 90 clusters, approx. 720 newborns Receives: Behavioral: Hand washing |
| Combined WASH | Active comparator | 90 clusters, approx. 720 newborns Receives: Behavioral: Water quality, Sanitation, Hand washing (Combined WASH) |
| Nutrition | Active comparator | 90 clusters, approx. 720 newborns Receives: Behavioral: Nutrition |
| Nutrition + Combined WASH | Active comparator | 90 clusters, approx. 720 newborns Receives: Behavioral: Nutrition, Water quality, Sanitation, Hand washing |
| Non-intervention | No intervention | 180 clusters, approx. 1,440 newborns |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length-for-Age Z-scores
Child's recumbent length, standardized to Z-scores using the WHO 2006 growth standards, measured 24monthsafter intervention. Measurement techniques follow the FANTA 2003 protocol.
Measured: Measured 24 months after intervention
Diarrhea Prevalence Diarrhea Prevalence Diarrhea Prevalence Diarrhea Prevalence
Diarrhea is defined as 3+ loose or watery stools in 24 hours or 1+ stools with blood in 24 hours. Diarrhea will be measured in interviews using caregiver-reported symptoms with 2-day and 7-day recall, measured 12- and 24-monthsafter intervention.
Measured: Measured 12- and 24-months after intervention
Secondary outcomes (4)
Length-for-Age Z-scores
Child's recumbent length, standardized to Z-scores using the WHO 2006 growth standards, measured 12monthsafter intervention. Measurement techniques follow the FANTA 2003 protocol.
Measured: Measured 12 months after intervention
Stunting Prevalence
Child's recumbent length, standardized to Z-scores using the WHO 2006 growth standards, measured 24monthsafter intervention. Measurement techniques follow the FANTA 2003 protocol. Children with length-for-age Z-scores < - 2 will be classified as stunted.
Measured: Measured 24 months after intervention
Enteropathy Biomarkers
The lactulose / mannitol dual sugar permeability test will be administered to children. The ratio of the recovery of the two sugars in the urine will be used to calculate the L:M ratio, and we will compare groups using logged values of the ratio. We will additionally measure Total IgG antibody titers in the blood, and we will compare groups using logged values of the antibody levels.
Measured: Measured 12- and 24 months after intervention
ASQ Child Development Scores
Interviewers will administer a locally adapted version of the Ages and Stages Questionnaire (ASQ)to children after 24 months of intervention. The ASQ includes item sets of caregiver-reported milestones that measure child development in three separate domains (gross motor, communication, personal/social skills).
Measured: Measured 24 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2012 (estimated)
- Study startMay 2012
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for MalnutritionStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 5,040 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Berkeley, University of California, Davis, Stanford University, Emory University, Innovations for Poverty Action
- Responsible party
- Sponsor
- Investigators
- Stephen P Luby, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01590095
- Sponsor's protocol ID
- PR-11063
- Other IDs
- 2011-09-3652 (UC Berkeley)
- Status last verified
- Jan 2022
- First submitted
- 30 Apr 2012
- Last updated
- 13 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Walas N, Kamau E, Zhang M, Kamath K, Reifert J, Shon J, Ali S, Rahman MZ, Shoab AK, Famida SL, Akther S, Hossen MS, Mutsuddi P, Rahman M, Grembi JA, Mertens AN, Bhuiyan TR, Qadri F, Ryan ET, Charles RC, Leung D, Luby S, Lin A, Arnold BF. Effects of improved water, sanitation, handwashing, and nutrition on early childhood IgG immune repertoire development against Shigella and enteroinvasive Escherichia coli (EIEC). mSphere. 2026 Jul 15:e0033926. doi: 10.1128/msphere.00339-26. Online ahead of print.
PubMed 42454929Chen B, Mertens AN, Lin CH, Tan ST, Jamshed F, Figueroa D, Hemlock C, Butzin-Dozier Z, Fernald LC, Stewart CP, Hubbard AE, Rahman MZ, Ali S, Arnold BF, Dhabhar FS, Granger DA, Rahman M, Luby SP, Colford JM Jr, Lin A. Associations Between Micronutrient Status, Hormones, and Immune Status During Pregnancy and Child Growth in Rural Bangladesh: A Prospective Cohort Study. Curr Dev Nutr. 2025 Nov 8;9(12):107596. doi: 10.1016/j.cdnut.2025.107596. eCollection 2025 Dec.
PubMed 41467215Tofail F, Pitchik HO, Islam M, Khan R, Shoab AK, Akter F, Aktar S, Huda TMN, Rahman M, Winch PJ, Luby SP, Fernald LCH. Effects of early water, sanitation, handwashing, and nutrition interventions on child development at school age: a follow-on study of a cluster-randomized trial in rural Bangladesh. PLoS Med. 2025 Dec 16;22(12):e1004793. doi: 10.1371/journal.pmed.1004793. eCollection 2025 Dec.
PubMed 41401135Lin A, Mertens AN, Rahman MZ, Tan ST, Il'yasova D, Spasojevic I, Ali S, Stewart CP, Fernald LCH, Kim L, Yan L, Meyer A, Karim MR, Shahriar S, Shuman G, Arnold BF, Hubbard AE, Famida SL, Akther S, Hossen MS, Mutsuddi P, Shoab AK, Shalev I, Rahman M, Unicomb L, Heaney CD, Kariger P, Colford JM Jr, Luby SP, Granger DA. A cluster-randomized trial of water, sanitation, handwashing and nutritional interventions on stress and epigenetic programming. Nat Commun. 2024 Apr 26;15(1):3572. doi: 10.1038/s41467-024-47896-z.
PubMed 38670986Ante-Testard PA, Rerolle F, Nguyen AT, Ashraf S, Parvez SM, Naser AM, Benmarhnia T, Rahman M, Luby SP, Benjamin-Chung J, Arnold BF. WASH interventions and child diarrhea at the interface of climate and socioeconomic position in Bangladesh. Nat Commun. 2024 Feb 20;15(1):1556. doi: 10.1038/s41467-024-45624-1.
PubMed 38378704Contreras JD, Islam M, Mertens A, Pickering AJ, Arnold BF, Benjamin-Chung J, Hubbard AE, Rahman M, Unicomb L, Luby SP, Colford JM Jr, Ercumen A. Evaluation of an on-site sanitation intervention against childhood diarrhea and acute respiratory infection 1 to 3.5 years after implementation: Extended follow-up of a cluster-randomized controlled trial in rural Bangladesh. PLoS Med. 2022 Aug 8;19(8):e1004041. doi: 10.1371/journal.pmed.1004041. eCollection 2022 Aug.
PubMed 35939520Lin A, Mertens AN, Arnold BF, Tan S, Lin J, Stewart CP, Hubbard AE, Ali S, Benjamin-Chung J, Shoab AK, Rahman MZ, Famida SL, Hossen MS, Mutsuddi P, Akther S, Rahman M, Unicomb L, Naved RT, Mamun MMA, Parvin K, Dhabhar FS, Kariger P, Fernald LC, Luby SP, Colford JM Jr. Telomere length is associated with growth in children in rural Bangladesh. Elife. 2021 Sep 8;10:e60389. doi: 10.7554/eLife.60389.
PubMed 34494545Kwong LH, Sen D, Islam S, Shahriar S, Benjamin-Chung J, Arnold BF, Hubbard A, Parvez SM, Islam M, Unicomb L, Rahman MM, Nelson K, Colford JM Jr, Luby SP, Ercumen A. Effect of sanitation improvements on soil-transmitted helminth eggs in courtyard soil from rural Bangladesh: Evidence from a cluster-randomized controlled trial. PLoS Negl Trop Dis. 2021 Jul 28;15(7):e0008815. doi: 10.1371/journal.pntd.0008815. eCollection 2021 Jul.
PubMed 34319986Contreras JD, Islam M, Mertens A, Pickering AJ, Kwong LH, Arnold BF, Benjamin-Chung J, Hubbard AE, Alam M, Sen D, Islam S, Rahman M, Unicomb L, Luby SP, Colford JM, Ercumen A. Longitudinal Effects of a Sanitation Intervention on Environmental Fecal Contamination in a Cluster-Randomized Controlled Trial in Rural Bangladesh. Environ Sci Technol. 2021 Jun 15;55(12):8169-8179. doi: 10.1021/acs.est.1c01114. Epub 2021 Jun 4.
PubMed 34086447Parvez SM, Rahman MJ, Azad R, Rahman M, Unicomb L, Ashraf S, Mondol MH, Jahan F, Winch PJ, Luby SP. Achieving equitable uptake of handwashing and sanitation by addressing both supply and demand-based constraints: findings from a randomized controlled trial in rural Bangladesh. Int J Equity Health. 2021 Jan 6;20(1):16. doi: 10.1186/s12939-020-01353-7.
PubMed 33407549Ercumen A, Benjamin-Chung J, Arnold BF, Lin A, Hubbard AE, Stewart C, Rahman Z, Parvez SM, Unicomb L, Rahman M, Haque R, Colford JM Jr, Luby SP. Effects of water, sanitation, handwashing and nutritional interventions on soil-transmitted helminth infections in young children: A cluster-randomized controlled trial in rural Bangladesh. PLoS Negl Trop Dis. 2019 May 3;13(5):e0007323. doi: 10.1371/journal.pntd.0007323. eCollection 2019 May.
PubMed 31050672Lin A, Ali S, Arnold BF, Rahman MZ, Alauddin M, Grembi J, Mertens AN, Famida SL, Akther S, Hossen MS, Mutsuddi P, Shoab AK, Hussain Z, Rahman M, Unicomb L, Ashraf S, Naser AM, Parvez SM, Ercumen A, Benjamin-Chung J, Haque R, Ahmed T, Hossain MI, Choudhury N, Jannat K, Alauddin ST, Minchala SG, Cekovic R, Hubbard AE, Stewart CP, Dewey KG, Colford JM, Luby SP. Effects of Water, Sanitation, Handwashing, and Nutritional Interventions on Environmental Enteric Dysfunction in Young Children: A Cluster-randomized, Controlled Trial in Rural Bangladesh. Clin Infect Dis. 2020 Feb 14;70(5):738-747. doi: 10.1093/cid/ciz291.
PubMed 30963177Stewart CP, Dewey KG, Lin A, Pickering AJ, Byrd KA, Jannat K, Ali S, Rao G, Dentz HN, Kiprotich M, Arnold CD, Arnold BF, Allen LH, Shahab-Ferdows S, Ercumen A, Grembi JA, Naser AM, Rahman M, Unicomb L, Colford JM Jr, Luby SP, Null C. Effects of lipid-based nutrient supplements and infant and young child feeding counseling with or without improved water, sanitation, and hygiene (WASH) on anemia and micronutrient status: results from 2 cluster-randomized trials in Kenya and Bangladesh. Am J Clin Nutr. 2019 Jan 1;109(1):148-164. doi: 10.1093/ajcn/nqy239.
PubMed 30624600Parvez SM, Azad R, Rahman M, Unicomb L, Ram PK, Naser AM, Stewart CP, Jannat K, Rahman MJ, Leontsini E, Winch PJ, Luby SP. Achieving optimal technology and behavioral uptake of single and combined interventions of water, sanitation hygiene and nutrition, in an efficacy trial (WASH benefits) in rural Bangladesh. Trials. 2018 Jul 6;19(1):358. doi: 10.1186/s13063-018-2710-8.
PubMed 29976251Rahman M, Ashraf S, Unicomb L, Mainuddin AKM, Parvez SM, Begum F, Das KK, Naser AM, Hussain F, Clasen T, Luby SP, Leontsini E, Winch PJ. WASH Benefits Bangladesh trial: system for monitoring coverage and quality in an efficacy trial. Trials. 2018 Jul 6;19(1):360. doi: 10.1186/s13063-018-2708-2.
PubMed 29976234
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WASH Benefits Bangladesh: A Cluster Randomized Controlled Trial of the Benefits of Water, Sanitation, Hygiene Plus Nutrition Interventions on Child Growth
- ClinicalTrials.gov ID
- NCT01590095
- Acronym / sponsor ID
- PR-11063
- Conditions
- Malnutrition, Diarrhea, Child Development
- Keywords
- Chlorine water treatment, Point-of-use water treatment, Household water treatment with safe storage, Hand washing with soap, Hand hygiene, Latrines, Child potties, Point-of-use fortification
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5,040 participants (estimated)
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, BangladeshUniversity, hospital or other
- Collaborators
- University of California, Berkeley, University of California, Davis, Stanford University, Emory University, Innovations for Poverty Action
- Study start
- May 2012
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 2 May 2012 (estimated)
- 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.
Brief Summary:
The purpose of this study is to measure the independent and combined effects of interventions that improve water quality, sanitation, hand washing, and nutrition on child growth and development in the first years of life.
Detailed description
Detailed Description:
Infection and inadequate diet are proximate risk factors for under-nutrition and early life growth faltering; the two processes likely act reciprocally in a vicious cycle that perpetuates physiologic and metabolic deficits and increases the risk of mortality. Children who exhibit growth faltering are more likely to have deficits in cognitive development and long-term human capital, and are more likely to have children who also suffer from growth deficits - perpetuating the cycle into the next generation.
There are two probable interdependent pathways that link enteric infections to child growth and development. The first pathway includes repeated infections the lead to acute illness or parasitic infection in the first years of life, which increase the risk of stunting and subsequent cognitive deficits in childhood and later in life. The second pathway is through a subclinical condition called environmental enteropathy (EE).
There is limited evidence to demonstrate whether or not water quality, sanitation, and hand washing (WASH) interventions can improve measures of EE, child growth and development, and whether nutritional interventions could be enhanced if provided concurrently with WASH interventions. To help fill this evidence gap, the WASH Benefits study will deliver randomized interventions designed to reduce infection and improve nutrition, and will measure intervention effects on child illness, growth and development. WASH Benefits includes two, comparable but standalone trials in Bangladesh and Kenya that are registered under separate protocols.
In Bangladesh, the study will include 720 clusters, and each cluster will enroll 8 household compounds (baris) with pregnant women in their second or third trimester. The study will randomize 90 clusters to each of 6 active intervention arms (water quality, sanitation, hand washing, combined WSH, nutrition, nutrition+WSH), and 180 clusters to a standard practices non-intervention arm. Children born into the cohort will be followed for 2 years after the intervention, with measurements at 12 and 24 months after intervention delivery. (anticipated age range: 20 - 27 months old at the final measurement). At the 12- and 24-month follow-up visits, the study will collect child anthropometric measurements and caregiver-reported diarrhea. In the final visit the study will administer a test to measure child development outcomes. The study will collect urine, blood, and stool specimens from a subsample of 1,500 children distributed across four arms of the study (Control, combined WSH, Nutrition, Nutrition+WSH) to measure biomarkers of gut function and intestinal parasitic infections at the 12- and 24-month follow-up visits. In addition, the study will collect specimens (blood, stool) from children 18 - 27 months old at baseline who are living in the same compound as target children to test for intestinal parasitic infections. At 24-months in all arms, the study will collect specimens stool from target children, children 18 - 27 months old at baseline, a school-aged child, and an adult who are living in the same compound as target children to test for intestinal parasitic infections. At 36-months in all arms, the study will collect specimens stool from target children, a school-aged child, and an adult who are living in the same compound as target children to test for intestinal parasitic infections.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Water quality | Active comparator | Behavioral: Water quality90 clusters, approx. 720 newborns |
| Sanitation | Active comparator | Behavioral: Sanitation90 clusters, approx. 720 newborns |
| Hand washing | Active comparator | Behavioral: Hand washing90 clusters, approx. 720 newborns |
| Combined WASH | Active comparator | Behavioral: Water quality, Sanitation, Hand washing (Combined WASH)90 clusters, approx. 720 newborns |
| Nutrition | Active comparator | Behavioral: Nutrition90 clusters, approx. 720 newborns |
| Nutrition + Combined WASH | Active comparator | Behavioral: Nutrition, Water quality, Sanitation, Hand washing90 clusters, approx. 720 newborns |
| Non-intervention | No intervention | –180 clusters, approx. 1,440 newborns |
Who may qualify
- Ages
- 1 day to 63 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Infants (target child) will be eligible to participate in the study if they are:
- They are in utero at the baseline survey
- Their parents/guardians are planning to stay in the study village for the next 12 months (if a mother is planning to give birth at her natal home and then return, she will still be a candidate for enrollment)
- Children < 36 months old at baseline that are living in the compound of a target child will be eligible to participate in diarrhea measurement if:
- They are < 36 months old at the baseline survey
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Water qualityHardware: Free supplies chlorine tablets (Aquatabs; NaDCC) and a safe storage vessel to treat and store drinking water. Promotion: Local promoters will visit study compounds at least monthly to deliver behavior change messages that focus on the treatment of all drinking water for children < 36 months of age. | Behavioural | Water quality |
| SanitationHardware: Free child potties, sani-scoop hoes to remove feces from household environments, latrine upgrades to a dual pit latrine Promotion: Local promoters will visit study compounds at least monthly to deliver behavior change messages that focus on the use of latrines for defecation and the removal of human and animal feces from the compound. | Behavioural | Sanitation |
| Hand washingHardware: Hand washing stations, soapy water bottles located at hand washing locations, detergent soap to supply soapy water bottles. Promotion: Local promoters will visit study compounds at least monthly to deliver behavior change messages that focus on hand washing with soap at critical times around food preparation, defecation, and contact with feces. | Behavioural | Hand washing |
| Water quality, Sanitation, Hand washing (Combined WASH)Hardware: Free supplies Aquatabs; (NaDCC) and a safe storage vessel to treat and store drinking water. Promotion: Local promoters will visit study compounds at least monthly to deliver behavior change messages that focus on the treatment of all drinking water for children < 36 months of age. Hardware: Free child potties, sani-scoop hoes to remove feces from household environments, latrine upgrades to a dual pit latrine. Promotion: Local promoters will visit study compounds at least monthly to deliver behavior change messages that focus on the use of latrines for defecation and the removal of human and animal feces from the compound. Hardware: Hand washing stations, soapy water bottles located at hand washing locations, detergent soap to supply soapy water bottles. Promotion: Local promoters will visit study compounds at least monthly to deliver behavior change messages that focus on hand washing with soap at critical times around food preparation, defecation, and contact with feces. | Behavioural | Combined WASH |
| NutritionSupplement: Lipid-based Nutrient Supplement (LNS) delivered daily from ages 6 to 24 months. Promotion: Local promoters will visit study compounds at least monthly to deliver behavior change messages modeled on those recommended in the Guiding Principles for Complementary Feeding of the Breastfed Child and the recent UNICEF Program Guide for Infant and Young Child Feeding Practices.General messages will include (1) practice exclusive breastfeeding from birth to 6 months of age and introduce complementary foods at 6 months of age while continuing to breastfeed; (2) continue breast feeding as you did before receiving LNS; (3) provide your child micronutrient-rich foods such as meat, fish, eggs, and vitamin A rich fruits and vegetables; and (4) feed your child at least 2-3 times per day when 6-8 months old and 3-4 times per day when 9-24 months old. | Behavioural | Nutrition |
| Nutrition, Water quality, Sanitation, Hand washingEach of the interventions described above for Water Quality, Sanitation \& Hand washing (Combined WASH) Plus the intervention described above for nutrition. | Behavioural | Nutrition + Combined WASH |
Primary outcome
Length-for-Age Z-scores
Time frame: Measured 24 months after intervention
Child's recumbent length, standardized to Z-scores using the WHO 2006 growth standards, measured 24monthsafter intervention. Measurement techniques follow the FANTA 2003 protocol.
Diarrhea Prevalence Diarrhea Prevalence Diarrhea Prevalence Diarrhea Prevalence
Time frame: Measured 12- and 24-months after intervention
Diarrhea is defined as 3+ loose or watery stools in 24 hours or 1+ stools with blood in 24 hours. Diarrhea will be measured in interviews using caregiver-reported symptoms with 2-day and 7-day recall, measured 12- and 24-monthsafter intervention.
4 secondary outcomes
Length-for-Age Z-scores
Time frame: Measured 12 months after intervention
Stunting Prevalence
Time frame: Measured 24 months after intervention
Enteropathy Biomarkers
Time frame: Measured 12- and 24 months after intervention
ASQ Child Development Scores
Time frame: Measured 24 months after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2022.
- Derived from this study: PubMed 42454929Walas N, Kamau E, Zhang M, Kamath K, Reifert J, Shon J, Ali S, Rahman MZ, Shoab AK, Famida SL, Akther S, Hossen MS, Mutsuddi P, Rahman M, Grembi JA, Mertens AN, Bhuiyan TR, Qadri F, Ryan ET, Charles RC, Leung D, Luby S, Lin A, Arnold BF. Effects of improved water, sanitation, handwashing, and nutrition on early childhood IgG immune repertoire development against Shigella and enteroinvasive Escherichia coli (EIEC). mSphere. 2026 Jul 15:e0033926. doi: 10.1128/msphere.00339-26. Online ahead of print.
- Derived from this study: PubMed 41467215Chen B, Mertens AN, Lin CH, Tan ST, Jamshed F, Figueroa D, Hemlock C, Butzin-Dozier Z, Fernald LC, Stewart CP, Hubbard AE, Rahman MZ, Ali S, Arnold BF, Dhabhar FS, Granger DA, Rahman M, Luby SP, Colford JM Jr, Lin A. Associations Between Micronutrient Status, Hormones, and Immune Status During Pregnancy and Child Growth in Rural Bangladesh: A Prospective Cohort Study. Curr Dev Nutr. 2025 Nov 8;9(12):107596. doi: 10.1016/j.cdnut.2025.107596. eCollection 2025 Dec.
- Derived from this study: PubMed 41401135Tofail F, Pitchik HO, Islam M, Khan R, Shoab AK, Akter F, Aktar S, Huda TMN, Rahman M, Winch PJ, Luby SP, Fernald LCH. Effects of early water, sanitation, handwashing, and nutrition interventions on child development at school age: a follow-on study of a cluster-randomized trial in rural Bangladesh. PLoS Med. 2025 Dec 16;22(12):e1004793. doi: 10.1371/journal.pmed.1004793. eCollection 2025 Dec.
- Derived from this study: PubMed 38670986Lin A, Mertens AN, Rahman MZ, Tan ST, Il'yasova D, Spasojevic I, Ali S, Stewart CP, Fernald LCH, Kim L, Yan L, Meyer A, Karim MR, Shahriar S, Shuman G, Arnold BF, Hubbard AE, Famida SL, Akther S, Hossen MS, Mutsuddi P, Shoab AK, Shalev I, Rahman M, Unicomb L, Heaney CD, Kariger P, Colford JM Jr, Luby SP, Granger DA. A cluster-randomized trial of water, sanitation, handwashing and nutritional interventions on stress and epigenetic programming. Nat Commun. 2024 Apr 26;15(1):3572. doi: 10.1038/s41467-024-47896-z.
- Derived from this study: PubMed 38378704Ante-Testard PA, Rerolle F, Nguyen AT, Ashraf S, Parvez SM, Naser AM, Benmarhnia T, Rahman M, Luby SP, Benjamin-Chung J, Arnold BF. WASH interventions and child diarrhea at the interface of climate and socioeconomic position in Bangladesh. Nat Commun. 2024 Feb 20;15(1):1556. doi: 10.1038/s41467-024-45624-1.
- Derived from this study: PubMed 35939520Contreras JD, Islam M, Mertens A, Pickering AJ, Arnold BF, Benjamin-Chung J, Hubbard AE, Rahman M, Unicomb L, Luby SP, Colford JM Jr, Ercumen A. Evaluation of an on-site sanitation intervention against childhood diarrhea and acute respiratory infection 1 to 3.5 years after implementation: Extended follow-up of a cluster-randomized controlled trial in rural Bangladesh. PLoS Med. 2022 Aug 8;19(8):e1004041. doi: 10.1371/journal.pmed.1004041. eCollection 2022 Aug.
- Derived from this study: PubMed 34494545Lin A, Mertens AN, Arnold BF, Tan S, Lin J, Stewart CP, Hubbard AE, Ali S, Benjamin-Chung J, Shoab AK, Rahman MZ, Famida SL, Hossen MS, Mutsuddi P, Akther S, Rahman M, Unicomb L, Naved RT, Mamun MMA, Parvin K, Dhabhar FS, Kariger P, Fernald LC, Luby SP, Colford JM Jr. Telomere length is associated with growth in children in rural Bangladesh. Elife. 2021 Sep 8;10:e60389. doi: 10.7554/eLife.60389.
- Derived from this study: PubMed 34319986Kwong LH, Sen D, Islam S, Shahriar S, Benjamin-Chung J, Arnold BF, Hubbard A, Parvez SM, Islam M, Unicomb L, Rahman MM, Nelson K, Colford JM Jr, Luby SP, Ercumen A. Effect of sanitation improvements on soil-transmitted helminth eggs in courtyard soil from rural Bangladesh: Evidence from a cluster-randomized controlled trial. PLoS Negl Trop Dis. 2021 Jul 28;15(7):e0008815. doi: 10.1371/journal.pntd.0008815. eCollection 2021 Jul.
- Derived from this study: PubMed 34086447Contreras JD, Islam M, Mertens A, Pickering AJ, Kwong LH, Arnold BF, Benjamin-Chung J, Hubbard AE, Alam M, Sen D, Islam S, Rahman M, Unicomb L, Luby SP, Colford JM, Ercumen A. Longitudinal Effects of a Sanitation Intervention on Environmental Fecal Contamination in a Cluster-Randomized Controlled Trial in Rural Bangladesh. Environ Sci Technol. 2021 Jun 15;55(12):8169-8179. doi: 10.1021/acs.est.1c01114. Epub 2021 Jun 4.
- Derived from this study: PubMed 33407549Parvez SM, Rahman MJ, Azad R, Rahman M, Unicomb L, Ashraf S, Mondol MH, Jahan F, Winch PJ, Luby SP. Achieving equitable uptake of handwashing and sanitation by addressing both supply and demand-based constraints: findings from a randomized controlled trial in rural Bangladesh. Int J Equity Health. 2021 Jan 6;20(1):16. doi: 10.1186/s12939-020-01353-7.
- Derived from this study: PubMed 31050672Ercumen A, Benjamin-Chung J, Arnold BF, Lin A, Hubbard AE, Stewart C, Rahman Z, Parvez SM, Unicomb L, Rahman M, Haque R, Colford JM Jr, Luby SP. Effects of water, sanitation, handwashing and nutritional interventions on soil-transmitted helminth infections in young children: A cluster-randomized controlled trial in rural Bangladesh. PLoS Negl Trop Dis. 2019 May 3;13(5):e0007323. doi: 10.1371/journal.pntd.0007323. eCollection 2019 May.
- Derived from this study: PubMed 30963177Lin A, Ali S, Arnold BF, Rahman MZ, Alauddin M, Grembi J, Mertens AN, Famida SL, Akther S, Hossen MS, Mutsuddi P, Shoab AK, Hussain Z, Rahman M, Unicomb L, Ashraf S, Naser AM, Parvez SM, Ercumen A, Benjamin-Chung J, Haque R, Ahmed T, Hossain MI, Choudhury N, Jannat K, Alauddin ST, Minchala SG, Cekovic R, Hubbard AE, Stewart CP, Dewey KG, Colford JM, Luby SP. Effects of Water, Sanitation, Handwashing, and Nutritional Interventions on Environmental Enteric Dysfunction in Young Children: A Cluster-randomized, Controlled Trial in Rural Bangladesh. Clin Infect Dis. 2020 Feb 14;70(5):738-747. doi: 10.1093/cid/ciz291.
- Related protocolLink provided by the sponsor.
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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.
Stephen P Luby, MD 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 Water quality, Sanitation and Hand washing in people with Malnutrition and Diarrhea, run by International Centre for Diarrhoeal Disease Research, Bangladesh 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 9 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 13 Apr 2022. 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?
Results are not available in the source record.
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?
Length-for-Age Z-scores (time frame: Measured 24 months after intervention). 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 NCT01590095, which also lists 19 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 13 Apr 2022.