None listed
Conditions
Brief summary
This project examines whether tap water effects the natural spatial and temporal organisation of the gut microbial communities (the microbiome) during infancy and early childhood. The addition of chlorine to metropolitan drinking water is one of the most effective means to deliver safe drinkable water because it produces a residual disinfectant that persists within the water distribution system. Levels of chlorine used to treat metropolitan water are considered safe for the individual based on toxicity studies. However, to our knowledge there have been no studies examining whether persistent chlorine exposure from tap water is also safe for the friendly gut bacteria that colonise the gastrointestinal tract. Chlorine has potent anti-microbial properties, and potentially forms disinfection by-products that can disrupt the intestinal microbiome in early childhood. Persistent exposure to low levels of chlorine may potentially cause an imbalance in the types of organisms present in the gut and may contribute to a range of health conditions. The present study is a randomized controlled trial (RCT) comparing the gut microbial colonisation patterns in early life. The RCT will enroll 220 healthy infants at six months of age, who will be randomised into two groups to experience the following drinking water regimes: 1) unmodified tap water as distributed by the local public water supply (‘control’ group); and 2) filtered tap water with chlorine and other contaminants removed (‘treatment’ group). Infants will be followed up through to 18 months of age. The primary outcome will be changes in the gut microbiome at 6 months, 12 months and 18 months of age. The secondary outcomes will be infant clinical health outcomes at 12 months and 2.5 years of age.
Interventions
Participants will be randomised into two groups to experience the following drinking water regimes for a period of up to 12 months: [1] Unmodified tap water as distributed by the local public water supply (n=100) (‘control’ group); and [2] Filtered tap water by means of activated carbon ion exchange to remove dissolved chlorine and other contaminants (n=100) (‘treatment’ group). Participants will be instructed to maintain normal practises around water consumption throughout the intervention peri
Participants will be randomised into two groups to experience the following drinking water regimes for a period of up to 12 months: [1] Unmodified tap water as distributed by the local public water supply (n=100) (‘control’ group); and [2] Filtered tap water by means of activated carbon ion exchange to remove dissolved chlorine and other contaminants (n=100) (‘treatment’ group). Participants will be instructed to maintain normal practises around water consumption throughout the intervention period. A benchtop water filtration unit fitted with a 0.5-micron carbon cartridge will be installed in participants’ homes. The filter has an output of 5,000 liters and should not require replacement within the 12-month period of intervention. The carbon block interior effectively removes chloramines, chlorine, pesticides and heavy metals, but does not remove fluoride so poses no risk to dental health. Sham filters will look identical but contain a sediment filter that only removes large sediment particles. Multipure Drinking Water Systems filter and housing units will be installed in participants' homes as the primary source of drinking water for infants. Multipure Drinking Water Systems filter and housing units are tested according to NSF/ANSI Standard 42 (Aesthetic Effects) and Standard 53 (Health Effects) [certification #C0303273]. Multipure drinking water systems are designed to be used where the water is microbiologically safe and has been adequately disinfected. The intervention group will receive housing units containing the Hi-Tech Optimizer carbon filtration blocks that are rated to reduce >97% of chloramines and >99% of chlorine, but do not remove fluoride. The control group will receive identical housing units that contain a sediment only filter that does not alter the chemical composition of tap water. To maintain the blind, the filtration units look identical and will be distributed to the TUMS team to install in participant homes by the independent randomisation party without notifying of the internal filter unit. Parents who wish to participate will be randomised to the treatment or control arm of the study and an appointment will be made for our investigator to visit their home for an initial recruitment visit. At the recruitment visit, the investigator will give an overview of the study, answer any questions and record consent into the study. The investigator will fit the benchtop water filter to the kitchen tap. The intervention will start from study entry at 6 months of age and continue until 18 months of age. We have chosen our intervention period to reflect current NHMRC infant feeding guidelines which recommend introducing boiled tap water (which removes chlorine) from 6 months, and unboiled tap water from 12 months. Therefore, our baseline sample of the microbiome at 6 months reflects a time-point where we expect little to no chlorine exposure, and our community survey of origins participants suggests this to be the case. The intervention period lasts for 12-months which represents a pragmatic study design as the filter cartridges are rated for 12-months or 5,000 litres.
Sponsors
Telethon Kids Institute
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
6 Months to 12 Months
Healthy volunteers
Yes
Inclusion criteria
Infants of age 6 months who meet the following criteria: • Born term • Without congenital birth defects • Are intending on remaining in the Perth metropolitan area for the next two years to the best of their knowledge • Speak English as the primary language at home
Exclusion criteria
• Enrolled in another dietary intervention study • Has received any antibiotics since birth • Home is not connected to public water supply • Currently using or intend to use a water filtration system or bottled water to prepare drinks for their infants within the next two years.
Outcome results
None listed