Outcome | Timing (age of child in months) | Antimicrobial intervention | Nicotinamide intervention |
Primary outcome | |||
LAZ | 18 | X | X |
Secondary outcomes | |||
Proportion of stunting (LAZ<–2) | 18 | X | X |
WAZ and WLZ z-scores | 18 | X | X |
Metabolomic assay of gut microbial metabolism and alterations to tryptophan-niacin and other pathways | 6, 12, 18 | X | X |
Tryptophan:kynurenine ratio and other pathway metabolites in serum | 12, 18 | X | X |
IGF-1 at 12 and 18 months | 12, 18 | X | X |
High-sensitivity C reactive protein at 12 and 18 months | 12, 18 | X | X |
Stool myeloperoxidase at months 6, 12 and 18 months | 6, 12, 18 | X | X |
Prevalence of enteric pathogens | 6, 6.5, 12, 12.5, 18 | X | X |
Change in microbiota (by traditional sequencing) (subset of participants) | 6, 6.5, 12, 18 | X | X |
Change in small intestinal bacterial overgrowth as assessed by exhaled increased hydrogen following ingestion of sugar (subset of participants) | 6, 12, 18 | X | X |
Difference in breast milk composition (nicotinamide, tryptophan, amino acids) | 1, 5 | X | |
Symptomatic diarrhoea | X | X | |
Hospitalisation and all-cause mortality | 18 | X | X |
Cognitive outcomes MDAT assessment and the Bayley Scales of Infant and Toddler Development | 18 | X | X |
IGF-1, insulin-like growth factor-1; LAZ, length-for-age Z-score; MDAT, Malawi Development Assessment Tool; WAZ, weight-for-age; WLZ, weight-for-length.