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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.