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Table 1 Outcomes, measures and methods of analysis

From: Oropharyngeal administration of colostrum targeting gut microbiota and metabolites in very preterm infants: protocol for a multicenter randomized controlled trial

Outcome

Hypothesis

Outcome Measure

Methods of Analysis

1.Primary

1a A between-group difference in Shannon diversity index at the 7th day

OAC increases Shannon diversity and metabolites of gut microbiota

Shannon index (continuous)

Individuals: Wilcoxon text; Intergroup: T/Wilcoxon text

1b A between-group difference in fecal metabolites at the 7th day

Short chain fatty acids (continuous)

Individuals: FC, PCA/PLS-DA

Intergroup: T/Wilcoxon text

2. Secondary

2a Between-group differences in other alpha diversity indexes (Simpson, Chao1) at the 7th day

OAC increases other alpha diversity and beta diversity, and changed the proportion of gut microbiota from birth to day 28. There is a Correlation between dominant microbiota and metabolites

Simpson index, Chao1 index (continuous)

Individuals: Wilcoxon text; Intergroup: T/Wilcoxon text

2b Between-group differences in Shannon index, Simpson index and Chao1 index at the 14th, 21st and 28th days of life

Shannon index, Simpson index, Chao1 index (continuous)

Individuals: Wilcoxon text; Intergroup: T/Wilcoxon text

2c Between-group differences in the concentration of fecal metabolites at the 14th, 21st and 28th days of life

Short chain fatty acids (continuous)

Individuals: FC, PCA/PLS-DA

Intergroup: T/Wilcoxon text

2d Proportion of gut microbiota (phylum and genus level)

The percentile of gut microbiota at the phylum and genus levels of the total microbiota (binary)

Individuals: Wilcoxon text; Intergroup: Chi-square test

2e Gut microbial beta diversity

Bray–Curtis distances with 9999 permutations (continuous)

PCOA; LDA

2f Correlation between dominant microbiota and metabolites

Correlation between dominant microbiota and metabolites

Partial Least Squares Discriminant Analysis

3.Subgroup Analysis

 ≤ 28w vs. > 28w

Gestational age affects adherence

All outcomes

Same as above

  1. OAC oropharyngeal administration of colostrum, FC fold change, PCA principal component analysis, PLS-DA partial least squares discriminant analysis, PCOA principal co-ordinates analysis, LDA linear discriminant analysis