None listed
Conditions
Brief summary
This study examines whether a nutritional supplement given to young children requiring antibiotics can reduce the risk of later development of obesity, allergic diseases like eczema and asthma, and the amount of other infectious illnesses they experience. The nutritional supplement is a prebiotic formulation aimed at modifying the gut microbiome and will be given to half the participants with every antibiotic course they may receive for the duration of the study. The other half of the participants will receive a placebo for comparison of the supplement's effect. The group allocation is random. Follow up assessments of weight, length/ height, eczema, asthma, infectious illnesses and stool samples will occur over 18months.
Interventions
Study nutritional supplement: 1.5g of prebiotics (per gram: 2'-Fucosyllactose 540mg, Lacto-N-tetraose 150mg, Lacto-N-neotetraose 140mg, 6'-Sialyllactose 120mg, 3'-Sialyllactose 50mg; collectively also known as complex breastmilk sugars) and 1.5g skim milk powder to be reconstituted with 15mL water; and administered in three divided doses over a day.
Participant caregivers will be shown how to reconstitute and administer the first dose.
Course: 10 days commencing with oral antibiotic therapy.
A
Study nutritional supplement: 1.5g of prebiotics (per gram: 2'-Fucosyllactose 540mg, Lacto-N-tetraose 150mg, Lacto-N-neotetraose 140mg, 6'-Sialyllactose 120mg, 3'-Sialyllactose 50mg; collectively also known as complex breastmilk sugars) and 1.5g skim milk powder to be reconstituted with 15mL water; and administered in three divided doses over a day. Participant caregivers will be shown how to reconstitute and administer the first dose. Course: 10 days commencing with oral antibiotic therapy. Adherence monitoring: daily text message reminders to participant caregivers to administer intervention. 2 phone reviews with caregivers during the intervention course to ask about doses successfully administered. The first participants enrolled will be asked to form the sub-group by providing two extra stool samples, until we reach sufficient numbers. The exclusion criterion for participation in the subgroup will be initial stool collection more than 48 hours from starting antibiotics. The sub-group will involve a total sample size of 90 (45 per group) to be sufficiently powered to detect a significant short-term reduction in Bifidobacterium bifidum relative abundance. The sub-group will have two extra brief visits by research staff, primarily for collection of stool samples on days 10 and 28 post-randomisation.
Study nutritional supplement: 1.5g of prebiotics (per gram: 2'-Fucosyllactose 540mg, Lacto-N-tetraose 150mg, Lacto-N-neotetraose 140mg, 6'-Sialyllactose 120mg, 3'-Sialyllactose 50mg; collectively also known as complex breastmilk sugars) and 1.0g dextrose powder to be reconstituted with 15mL water; and administered in three divided doses over a day.
Participant caregivers will be shown how to reconstitute and administer the first dose.
Course: 10 days commencing with oral antibiotic therapy.
Ad
Study nutritional supplement: 1.5g of prebiotics (per gram: 2'-Fucosyllactose 540mg, Lacto-N-tetraose 150mg, Lacto-N-neotetraose 140mg, 6'-Sialyllactose 120mg, 3'-Sialyllactose 50mg; collectively also known as complex breastmilk sugars) and 1.0g dextrose powder to be reconstituted with 15mL water; and administered in three divided doses over a day. Participant caregivers will be shown how to reconstitute and administer the first dose. Course: 10 days commencing with oral antibiotic therapy. Adherence monitoring: daily text message reminders to participant caregivers to administer intervention. 2 phone reviews with caregivers during the intervention course to ask about doses successfully administered. The first participants enrolled will be asked to form the sub-group by providing two extra stool samples, until we reach sufficient numbers. The exclusion criterion for participation in the subgroup will be initial stool collection more than 48 hours from starting antibiotics. The sub-group will involve a total sample size of 90 (45 per group) to be sufficiently powered to detect a significant short-term reduction in Bifidobacterium bifidum relative abundance. The sub-group will have two extra brief visits by research staff, primarily for collection of stool samples on days 10 and 28 post-randomisation.
Sponsors
University of Auckland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
12 Months to 15 Months
Healthy volunteers
No
Inclusion criteria
- Aged 12 to 15 months - Have mostly stopped taking breastmilk or formula - Residence in the Auckland region - Prescribed a course of oral antibiotics for an acute infection - Caregiver able and willing to provide written informed consent and complete questionnaires in English
Exclusion criteria
- Severe chronic conditions requiring repeated hospitalisations - Major congenital anomaly or chronic condition expected to affect growth or immune function (e.g. cystic fibrosis) - Prior gastrointestinal surgery (e.g. bowel resection or stoma) - Hospitalised at time of recruitment - Frequent watery stools - Preterm birth - Small for gestational age (SGA) - >100mL/ day infant/ toddler follow-on formula containing pre-biotic oligosaccharides - Ongoing intake of a specific probiotic supplement - Antibiotics within 4 weeks of enrolment (excluding the current course)
Outcome results
None listed