Digestive System Nutritional, Metabolic, Endocrine Paediatrics
Conditions
Interventions
Sponsors
Liverpool School of Tropical Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: singleton newborn birthweight (BW) or current weight (if BW not known) ?2000g well infant who is breastfed and has taken at least one breast feed well lives within the catchment area of the research centre at Homa Bay Hospital informed consent secured from mother/carer
Exclusion criteria
Exclusion criteria: multiple pregnancy (e.g. twin/triplets) infant aged 4 days or older suspicion or presence of any acute illness (e.g. fever, receiving treatment with antibiotics) congenital abnormality that might be life-threatening or impair growth infant with potential contraindication to pre/synbiotics (e.g. suspected immune suppression; cardiac abnormality) mother unlikely to stay in study area for the duration of the study any health staff or study staff concerns regarding safety to participate in the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma alpha-1-acid glycoprotein concentration | — |
Secondary
| Measure | Time frame |
|---|---|
| Biomarkers at ages 6 weeks and 3, 6 and 12 months 1. Stool biomarker of intestinal inflammation: Myeloperoxidase 2. Stool biomarker of increased intestinal permeability: a1-antitrypsin (AAT) 3. Plasma marker of chronic inflammation: alpha 1-Acid Glycoprotein at 6 weeks and 3 and 12 months 4. Plasma marker of acute inflammation: C-reactive protein (CRP) 5. Plasma marker of gut mucosal integrity: intestinal fatty acid binding protein (IFABP) 6. Plasma growth hormones: insulin-like growth factor (IGF)-1 and its carrier protein IGF binding protein 3 7. Stool pH Clinical outcomes to age 2 years 1. Mortality 2. Episodes of hospital admission 3. Episodes of all-cause sick-child clinic visits 4. Episodes of disease-specific sick-child clinic visits (e.g. diarrhoea; respiratory and skin infections) 5. Anthropometric outcomes: weight, length, mid-upper arm circumference (MUAC), head circumference Other outcomes 1. Feeding and WASH practices and environmental factors that likely influence the development of the gut microbiome assessed by questionnaires 2. Cognitive development assessed at 24 months | — |
Countries
Kenya
Contacts
Public ContactIwaret Otiti
Study Manager
Outcome results
None listed