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Table 5 Reported outcomes and conclusions

From: Association between funding source, methodological quality and research outcomes in randomized controlled trials of synbiotics, probiotics and prebiotics added to infant formula: A Systematic Review

       

N (%)

     

Variable

N=

No conclusion

Positive

Neutral

Negative

Variable

 

N (%)

Overall study conclusion

67

4 (6)

49 (73.1)

7 (10.4)

7 (10.4)

Reported Outcomes

N=

Positive*

Neutral*

Negative*

Conclusion on reported outcomes

     

Weight gain

56

4 (7.1)

52 (92.9)

 

Weight gain

56

40 (71.4)

15 (26.8)

 

1 (1.8)

Length gain

40

3 (7.5)

37 (92.5)

 

Length gain

40

26 (65)

14 (35)

  

Head circumference

31

4 (12.9)

27 (87.1)

 

Head circumference

31

17 (54.8)

14 (45.2)

  

Colic

13

1 (7.7)

12 (92.3)

 

Colic

13

11 (84.6)

2 (15.4)

  

Spitting up/Regurgitation

26

2 (7.7)

23 (88.5)

1 (3.8)

Spitting up/Regurgitation

26

23 (88.5)

3 (11.5)

  

Vomiting

31

1.5 (3.2

30 (96.8)

 

Vomiting

32

24 (75)

8 (25)

  

Crying/Fussiness

22

3 (13.6)

18 (81.8)

1 (4.5)

Crying/Fussiness

20

12 (60)

8 (40)

  

Gastric Residuals, Abdominal distension

5

1 (20)

4 (80)

 

Gastric Residuals, Abdominal distension

6

3 (50)

3 (50)

  

Volume of formula consumed

31

3 (9.7)

27 (87.1)

1 (3.2)

Volume of formula consumed

30

26 (86.7)

3 (10)

 

1(3.3)

Time to full enteral feeds

9

2 (22.2)

7 (77.8)

 

Time to full enteral feeds

8

5 (62.5)

2 (25)

 

1 (12.5)

Stool frequency

37

10 (27)

27 (73)

 

Stool frequency

38

27 (71.1)

11 (28.9)

  

Stool consistency

37

18 (48.6)

19 (51.4)

 

Stool consistency

39

23 (59)

16 (41.0)

  

Stool pH

13

11 (84.6)

2 (15.4)

 

Stool pH

12

7 (58.3)

5 (41.7)

  

Short chain fatty acids

9

3 (33.3)

6 (66.7)

 

Short chain fatty acids

9

5 (55.6)

4 (44.4)

  

Flatulence/Gas

16

 

16 (100)

 

Flatulence/Gas

15

11 (73.3)

4 (26.7)

  

Diarrhoea, Diarrhoea episodes

19

3(15.8)

15 (78.9)

1(5.3)

Diarrhoea, Diarrhoea episodes

18

12 (66.7)

5 (27.8)

 

1 (5.6)

Constipation

3

1 (33.3)

2 (66.7)

 

Constipation

4

3 (75)

1 (25)

  

Microflora - Bifidobacteria

31

23 (74.2)

8 (25.8)

 

Microflora - Bifidobacteria

30

10 (33.3)

17 (56.7)

2 (6.7)

1 (3.3)

Microflora - Lactobacillus

19

8 (42.1)

11 (57.9)

 

Microflora - Lactobacillus

19

9 (47.4)

8 (42.1)

1 (5.3)

1 (5.3)

Microflora - Pathogens

25

5 (20)

19 (76)

1 (4)

Microflora - Pathogens

25

12 (48)

11 (44)

 

2 (8)

Immune response CRP, IL6, Cytokines

0

   

Immune response CRP, IL6, Cytokines

1

1 (100)

   

Immunoglobulins (IgA,IgG, Ig-Flc, IgE)

10

6 (60)

4 (40)

 

Immunoglobulins (IgA,IgG, Ig-Flc, IgE)

10

4 (40)

6 (60)

  

Allergy

3

1 (33.3)

2 (66.7)

 

Allergy

3

2 (66.7)

1 (33.3)

  

Eczema, Dermatitis, Rash, Skin Alterations

7

2 (28.6)

4 (57.1)

1 (14.3)

Eczema, Dermatitis, Rash, Skin Alterations

7

5 (71.4)

1 (14.3)

 

1 (14.3)

Infections - Acute Otitis Media

3

 

3 (100)

 

Infections - Acute Otitis Media

3

1 (33.3

2 (66.7)

  

Respiratory Infections

9

3 (33.3)

6 (66.7)

 

Respiratory Infections

8

5 (62.5)

3 (37.5)

  

Gastrointestinal infections

6

1 (16.7)

5 (83.3)

 

Gastrointestinal infections

4

1 (25)

3 (75)

  

Total infections, other unspecified infections

8

1 (12.5)

7 (87.5)

 

Total infections, other unspecified infections

10

6 (60)

2 (20)

 

2 (20)

Urinary tract infections

2

 

2 (100)

 

Urinary tract infections

2

1 (50)

1 (50)

  

Necrotizing Enterocolitis

11

2 (18.2)

9 (81.8)

 

Necrotizing Enterocolitis

12

7 (58.3)

3 (25)

 

2 (16.7)

Sepsis

10

 

10 (100)

 

Sepsis

10

9 (90)

1 (10)

  

Fever, Febrile Episodes

4

2 (50)

2 (50)

 

Fever, Febrile Episodes

2

2 (100)

   

Antibiotic use

19

4 (21.1)

15 (78.9)

 

Antibiotic use

16

13 (81.3)

3 (18.8)

  

Hospitalization

12

 

12 (100)

 

Hospitalization

10

10 (100)

   

Biochemical measures

9

 

9 (100)

 

Biochemical measures

6

5 (83.3)

1 (16.7)

  

Adverse events

18

2 (11.1)

16 (88.9)

 

Adverse events

17

13 (76.5)

4 (23.5)

  

Death / Mortality

7

1 (14.3

6 (85.7)

 

Death/Mortality

8

7 (87.5)

1 (12.5)

  

Intestinal permeability

3

1 (33.3)

2 (66.7)

 

Intestinal permeability

3

1 (33.3)

2 (66.7)

  

Duration of TPN

5

 

5 (100)

 

Duration of TPN

5

4 (80)

1 (20)

  
  1. *Positive: synbiotic, probiotic or prebiotic supplementation had a statistically significant effect, p < 0.05.
  2. *Neutral: synbiotic, probiotic or prebiotic supplementation did not have a statistically significant effect, p > 0.05.
  3. *Negative: synbiotic, probiotic or prebiotic supplementation had a statistically significant increase in an adverse event / negative outcome, p < 0.05.
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BMC Medical Research Methodology

ISSN: 1471-2288

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