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Table 2 Composite IGSQ and domain scoresa at baseline, week 4, and week 8, by feeding group, analysis set (N = 106)

From: Real-world evidence study on tolerance and growth in infants fed an infant formula with two human milk oligosaccharides vs mixed fed and exclusively breastfed infants

 

BF

MF

 

FF

 

N

Mean

SD

Min–Max

N

Mean

SD

Min–Max

p-value2

N

Mean

SD

Min–Max

p-value2

Composite IGSQ score

 

Baseline

38

20.33

4.30

13–32

22

21.82

5.27

13–37

0.279

46

25.50

8.31

15–50

< 0.001

Week 4

38

19.20

4.05

13–29

22

20.45

4.73

13–32

0.563

43

21.94

5.64

13–37

0.127

Week 8

38

18.76

3.97

14–32

22

18.14

3.67

13–25

0.298

45

19.08

5.49

13–36

0.548

IGSQ domains

Stooling

Baseline

38

2.68

1.21

2–6

22

2.95

1.36

2–6

0.769

45

4.04

2.45

2–10

0.001

Week 4

37

2.54

0.99

2–6

22

3.00

1.41

2–6

0.364

43

3.05

1.66

2–8

0.549

Week 8

38

2.66

1.02

2–6

22

2.73

1.39

2–7

0.994

45

2.58

1.20

2–6

0.590

Spitting up/vomiting

Baseline

37

5.68

1.70

4–9

21

6.38

2.64

4–12

0.293

45

7.16

2.97

4–16

0.005

Week 4

38

5.84

2.05

4–14

22

5.91

1.85

4–11

0.758

42

6.12

2.25

4–12

0.949

Week 8

38

5.53

1.37

4–10

22

5.09

1.63

4–11

0.183

44

5.77

2.25

4–12

0.731

Crying

Baseline

38

4.16

1.22

3–7

22

4.32

1.46

3–8

0.659

46

5.11

2.28

3–13

0.015

Week 4

38

4.00

0.96

3–6

22

4.09

1.48

3–8

0.802

43

4.91

1.99

3–10

0.035

Week 8

38

4.37

1.20

3–8

22

3.95

1.33

3–7

0.143

45

4.24

1.65

3–11

0.214

Fussiness

Baseline

38

2.66

1.70

2–10

22

2.59

1.18

2–6

0.931

45

3.31

2.00

2–10

0.095

Week 4

38

2.45

0.89

2–6

22

2.59

1.26

2–7

0.522

43

3.40

2.27

2–10

0.028

Week 8

38

2.37

1.36

2–10

22

2.32

0.78

2–5

0.928

45

2.71

1.66

2–10

0.420

Gassiness

Baseline

38

5.11

1.75

2–9

22

5.45

2.18

2–9

0.387

45

5.82

2.06

2–10

0.078

Week 4

38

4.37

1.55

2–7

22

4.86

1.58

2–8

0.405

43

4.44

1.76

2–8

0.613

Week 8

38

3.84

1.75

2–8

22

4.05

1.65

2–8

0.976

45

3.80

1.80

2–7

0.452

  1. BF exclusively breastfed group, MF mixed fed group, FF formula fed group (exclusively), SD standard deviation
  2. 2p-value compared to BF
  3. aThe IGSQ consists of 13 individual questions (grouped into five domains). Each question is scored on a scale of 1 to 5 with higher values indicating greater GI distress. The composite IGSQ score is derived by summing the individual scores, resulting in a possible range of 13 to 65 where higher values indicate greater GI distress. A composite IGSQ ≤ 23 indicates no digestive distress