Digestive System Nutritional, Metabolic, Endocrine Paediatrics
Conditions
Interventions
Routine care
Sponsors
Liverpool School of Tropical Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) singleton newborn 2) birth weight (BW) or current weight (if BW not known) 2000g or more 3) well infant who is breastfed and has taken at least one breastfeed well 4) age 1-3 days 5) informed consent secured from mother/carer 6) Infants of HIV positive women without known immunosuppression
Exclusion criteria
Exclusion criteria: 1) multiple pregnancy (e.g. twin/triplets) 2) suspicion or presence of any acute illness (e.g. fever, receiving treatment with antibiotics) 3) congenital abnormality that might be life-threatening or impair growth 4) infant with potential contraindication to synbiotic (e.g. suspected immune suppression; cardiac abnormality) 5) mother unlikely to stay in study area for the duration of the study 6) any health staff or study staff concerns regarding safety to participate in the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Linear growth | — |
Secondary
| Measure | Time frame |
|---|---|
| Enteropathogens and biomarkers in stool 1. Enteropathogens: Salmonella, Shigella, E. coli, Vibrio, Yersinia, Aeromonas and Plesiomonas detected by analysis of faecal microbiome and bacterial culture with confirmation by serological and biochemical assays as appropriate; E. coli subtypes identified by multiplex PCR; ova, cysts and parasites by microscopy. 2. Stool biomarker of intestinal inflammation: Myeloperoxidase 3. Stool biomarker of increased intestinal permeability: a1-antitrypsin (AAT);Biomarkers in blood 4. Plasma marker of chronic inflammation: alpha-1-acid glycoprotein (AGP) 5. Plasma marker of acute inflammation: C-reactive protein (CRP) 6. Plasma marker of gut mucosal integrity: intestinal fatty acid binding protein (IFABP) 7. Plasma growth hormones: insulin-like growth factor (IGF)-1 and its carrier protein IGF binding protein 3;Clinical outcomes 8. Mortality 9. Weekly morbidity diary 10. Episodes of hospital admission 11. Episodes of sick-child clinic visits, e.g. diarrhoea; respiratory and skin infections 12. Anthropometric outcomes: weight, mid-upper arm circumference (MUAC), head circumference, skin folds, knee-heel length. | — |
Countries
Senegal
Contacts
Public ContactBenjamin Momo Kadia
Clinical Research Associate at Liverpool School of Tropical Medicine
Outcome results
None listed