Endpoints to be measured in the TAME trial
| Units | How measured | |
| Primary endpoint | ||
| Faecal α-1-antitrypsin, myeloperoxidase and neopterin concentrations | mg/g, μg/ml, μmol/l | ELISA |
| Secondary endpoints | ||
| Lactulose:rhamnose ratio (Zambia only) | HPLC | |
| Plasma intestinal fatty acid binding protein concentration | ng/ml | ELISA |
| Plasma lipopolysaccharide (LPS) | EU/ml | Limulus amoebacyte lysate |
| Plasma LPS binding protein | ng/ml | ELISA |
| Plasma soluble CD14 and CD163 | μg/ml | ELISA |
| Plasma C-reactive protein | mg/l | ELISA |
| Plasma albumin | g/l | ELISA |
| Mortality by day 14 and day 28 | Clinical assessment | |
| Change in anthropometric measurements (weight, mid upper arm circumference, weight-for-height, MUAC) between baseline and day 14, and baseline and day 28 | Weight and length measurements | |
| Resolution of oedema between baseline and day 14 | Clinical assessment | |
| Adverse events between baseline and day 14 | Clinical assessment | |
| Serious adverse events between baseline and day 14 | Clinical assessment | |
| Days with diarrhoea (three or more loose or watery stools in 24 hours) between baseline and day 14 | Clinical assessment | |
| Days with fever (two or more recordings of core temperature of 37.8°C or higher in any 24 hours period) between baseline and day 14 | Clinical assessment | |
| Hormones: GLP-2, IGF-1 and IGFBP3 | ng/ml | ELISA |
| Morphometric measures on biopsy specimens collected in Zambia only: villus height, crypt depth, villus width, epithelial surface perimeter | μm | Microscopy |
| Mucosal inflammatory scores | Ordinal scale | Microscopy |
GLP-2, glucagon-like peptide 2; IGF, insulin-like growth factor; IGFBP, IGF binding protein; MUAC, mid upper arm circumference; TAME, Therapeutic Approaches for Malnutrition Enteropathy.