Background
Objective
Hypothesis
Methods
Criteria for considering studies for this review
Types of studies
Types of outcome
Search methods for identification of studies
Selection of studies
Data extraction and management
A) Source of funding or support of RCTs
-
For – profit company, donation of study product by a for – profit company which manufactured the study product,
-
Not – for profit company that promoted the consumption of synbiotics, probiotics or prebiotics,
-
Mixed sources (for-profit company and other source).
-
Government: National, regional (provincial, county) government body with NO industry association.
-
Foundation / Philanthropies: examples include Rockefeller foundation, Bill and Melinda Gates foundation.
-
Institution: University, Research centres, teaching and academic hospitals.
-
Other source of funding.
B) Assessment of methodological quality of evidence (Risk of bias)
C) Assessment of clinical outcomes
D) Overall study conclusions and conclusions on reported outcomes
Statistical Analysis
Ethics
Results
Results of the search and description of studies
Included studies | On-going studies | ||||||
---|---|---|---|---|---|---|---|
Author publication year | Full term/Preterm infant | Sponsor | Author publication year | Full term/Preterm infant | Sponsor | Author, Year study commenced | Full term/Preterm infant |
Allen 2010 [18] | Full Term | Knowledge exploitation fund, collaborative industrial research, others | Soh 2009 [19] | Full Term | National Medical Research Council, Singapore | Jacobs 2007 [20] | Pre-Term |
Alliet 2007 [21] Scholtens 2008 [22] | Full Term | Numico | Urban 2008 [23] | Full Term | Nestle | Patole 2009 [24] | Pre-Term |
Ashley 2012 [25] | Full Term | Mead Johnson | Velaphi 2008 [26] | Full Term | Nestle | Underwood 2009 [27] | Pre-Term |
Full Term | None/Not clear | Vendt 2006 [30] | Full Term | Valio Ltd | |||
Bettler 2006 [31] | Full Term | Wyeth Nutrition | Vlieger 2009 [32] | Full Term | Friesland | ||
Brunser 2006 [33] | Full Term | None/Not clear | Weizman 2005 [34] | Full Term | Materna Laboratories | ||
Bruzzese 2009 [35] | Full Term | Numico | Weizman 2006 [36] | Full Term | Marterna Laboratories | ||
Chouraqui 2004 [37] | Full Term | Nestle | Xiao-Ming 2004 [38] | Full Term | Friesland | ||
Chouraqui 2008 [39] | Full Term | Nestle | Xiao-Ming 2008 [40] | Full Term | None / Not clear | ||
Copper 2010 [41] | Full Term | Nestle | Ziegler 2007 [42] | Full Term | Mead Johnson | ||
Costalos 2008 [43] | Full Term | Numico | Bin-Nun 2005 [44] | Pre-Term | Mr and Mrs Stephen Hammerman, Mirsky Research fund | ||
Decsi 2005 [45] | Full Term | Numil Ltd | Pre-Term | Numico | |||
Fanaro 2005 [49] | Full Term | None / Not clear | Chrzanowska-Liszewska 2012 [50] | Pre-Term | None/Not clear | ||
Fanaro 2008 [51] | Full Term | Humana GmbH | Costalos 2003 [52] | Pre-Term | None/Not clear | ||
Gibson 2009 [53] | Full Term | Nestle | Dani 2002 [54] | Pre-Term | None/Not clear | ||
Gil-Campos 2012 [55] | Full Term | Puleva | Indrio 2008 [56] | Pre-Term | Bio Gaia | ||
Hascoet 2011 [57] | Full Term | Nestle | Indrio 2009 [58] | Pre-Term | Numico | ||
Holscher 2012a [59] | Full Term | Nestle | Kapiki 2007 [60] | Pre-Term | None/Not clear | ||
Holscher 2012b [61] | Full Term | Nestle | Kitajima 1992 [62] | Pre-Term | None/Not clear | ||
Kim 2010 [63] | Full Term | Ministry of Health, Welfare and family affairs. Republic of Korea | Lin H-C 2008 [64] | Pre-Term | National Science Council of Taiwan | ||
Knol 2005 [65] | Full Term | Numico | Mihatsch 2006 [66] | Pre-Term | Milupa GmbH | ||
Magne 2008 [67] | Full Term | Numico | Mihatsch 2010 [68] | Pre-Term | Nestle | ||
Mah 2007 [69] | Full Term | National Medical Research Council Singapore | Pre-Term | Wessex Regional Health Authority and childrens Research fund | |||
Maldonado 2010 [72] | Full Term | Puleva | Modi 2010 [73] | Pre-Term | Danone | ||
Full Term | None/Not clear | Mohan 2006 [76] | Pre-Term | None/Not clear | |||
Moro 2005 [77] | Full Term | None/Not clear | Reuman1986 [78] | Pre-Term | None/Not clear | ||
Full Term | Numico | Riskin 2009 [84] | Pre-Term | None/Not clear | |||
Piemontese 2011 [85] | Full Term | Danone | Rouge 2009 [86] | Pre-Term | French Ministry of Health | ||
Puccio 2007 [87] | Full Term | Nestle | Sari 2011 [88] | Pre-Term | None/Not clear | ||
Full Term | Microbes and Man Research program, Academy of Finland, others | Stratiki 2007 [91] | Pre-Term | Nestle | |||
Rinne 2005 [92] | Full Term | Academy of Finland, Turku University Central Hospital Research Funds | Pre-Term | Danone | |||
Saavedra 2004 [96] | Full Term | Nestle | Yong 2009 [97] | Pre-Term | None/Not clear | ||
Scalabrin 2009 [98] | Full Term | Mead Johnson | |||||
Scalabrin 2012 [99] | Full Term | Mead Johnson | |||||
Schmelzle 2003 [100] | Full Term | Numico |
Use of Exclusive breast milk or Other milk feeds (buffalo, goat milk) | Type of feed not clear/specified | Probiotic administered in water, saline or other fluid that is not infant formula | No use of probiotic, prebiotic | Not RCT, (Cross over, Follow up, Observational study) | Different inclusion criteria | Lack of suitable/ knowledgeable translator | Data presentation inappropriate | Out dated (published before 1980) |
---|---|---|---|---|---|---|---|---|
Agarwal 2003 [101] | Al Hosni 2012 [102] | FengJuan 2008 [103] | Morisset 2011 [104] | Huet 2006 [105] | Agustina 2007 [106] | Akiyama1994a [107] (Japanese) | Grzéskowak 2012 [108] | Andrews 1969 [109] |
Baldeon 2008 [110] | Campeotto 2011 [111] | Kuitunen 2009 [112] | Patole 2005 [113] | Bongers 2007 [114] | Correa 2005 [115] | Akiyama1994b [116] (Japanese) | Robinson 1952 [117] | |
Braga 2011 [118] | Cukrowska 2002 [119] | Kukkonen 2007 [120] | Rochat 2007 [121] | Chou I-C 2009 [122] | Hol 2008 [123] | |||
Chandra 2002 [124] | *Karvonen 1999 [125] | Kukkonen 2008 [126] | Taipale 2011 [127] | Euler 2005 [128] | Isolauri 2000 [129] | |||
Lin H-C 2005 [130] | *Karvonen 2001 [131] | Taylor 2009 [132] | Hoyos 1999 [133] | Nopchinda 2002 [134] | ||||
Manzoni 2006 [135] | *Karvonen 2002 [136] | Thibault 2004 [137] | Kim 2007 [138] | Rivero 2004 [139] | ||||
Rinne 2006 [140] | Li 2004 [141] | Lee 2007 [142] | Urao 1999 [143] | |||||
Samanta 2009 [144] | Panigrahi 2008 [145] | Lidesteri 2003 [146] | Van der Aa 2010 [147] | |||||
Rojas 2012 [148] | Marini 2003 [149] | Waliogora-Dupriet 2007 [150] | ||||||
Taylor 2007 [151] | Rigo 2001 [152] | Wang 2007 [153] | ||||||
Underwood 2009 [154] | Savino 2003 [155] | |||||||
Sepp 1993 [156] |
Characteristics of included studies
Study participants | |||
---|---|---|---|
Sponsor | Full term infant | Preterm Infant | Total |
n | n | n (%) | |
Industry | 33 | 7 | 40 (59.7) |
None / Not Clear | 6 | 10 | 16 (23.9) |
Non Industry | 6 | 5 | 11 (16.4) |
Total | 45 | 22 | 67 (100.0) |
Funding
Methodological quality (Risk of bias)
N (%) | |||
---|---|---|---|
Quality of studies N = 67 | Low risk | High risk | Unclear |
Sequence generation | 42 (62.7) | 25 (37.3) | |
Allocation concealment | 32 (47.8) | 35 (52.2) | |
Blinding | 31 (46.3) | 36 (53.7) | |
Incomplete Outcome data | 52 (77.6) | 1 (1.5) | 14 (20.9) |
Selective reporting | 57 (85.1) | 7 (10.4) | 3 (4.5) |
Other bias | 53 (79.1) | 14 (20.9) |
Outcomes and study conclusions
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) |
Association between source of funding (sponsor) and methodological quality of studies
Methodological quality | Source of funding | Yes (Low risk) | No (High risk) | Unclear | Chi-square p value | Fisher’s exact p value |
---|---|---|---|---|---|---|
N = 67 studies | n (%)$$
| n (%)$$
| n (%)$$
| |||
Sequence generation
| Industry | 26 (38.8) | 14 (20.9) | 0.435 | 0.465 | |
None/Not clear | 8 (11.9) | 8 (11.9) | ||||
Non industry | 8 (11.9) | 3 (4.5) | ||||
Allocation concealment
| Industry | 21 (31.3) | 19 (28.4) | 0.315 | 0.338 | |
None/Not clear | 5 (7.5) | 11 (16.4) | ||||
Non Iindustry | 6 (9.0) | 5 (7.5) | ||||
Blinding
| Industry | 18 (26.9) | 22 (32.8) | 0.395 | 0.457 | |
None/Not clear | 6 (9.0) | 10 (14.9) | ||||
Non industry | 7 (10.4) | 4 (6.0) | ||||
Incomplete outcome data
| Industry | 36 (53.7) | 1 (1.5) | 3 (4.5) | 0.023* | 0.005* |
None/Not clear | 9 (13.4) | 7 (10.4) | ||||
Non industry | 7 (10.4) | 4 (6.0) | ||||
Selective reporting
| Industry | 36 (53.7) | 2 (3.0) | 2 (3.0) | 0.224 | 0.188 |
None/Not clear | 11 (16.4) | 4 (6.0) | 1 (1.5) | |||
Non industry | 10 (14.9) | 1 (1.5) | 0 | |||
Free of other bias
| Industry | 35 (52.2) | 5 (7.5) | 0.033* | 0.038* | |
None/Not clear | 9 (13.4) | 7 (10.4) | ||||
Non industry | 8 (13.4) | 1 (1.5) | 2 (3.0) |
Association between source of funding (sponsor) and clinical outcomes
Assessment of outcome | |||||
---|---|---|---|---|---|
Growth | Source of funding | Positive* | Neutral* | Chi-square p value | Fisher’s exact p value |
n (%)$$
| n (%)$$
| ||||
Weight gain N = 56 | Industry | 2 (3.6) | 35 (62.5) | 0.309 | 0.266 |
None/Not clear | 2 (3.6) | 10 (17.9) | |||
Non industry | 0 | 7 (12.5) | |||
Length gain N = 40 | Industry | 3 (7.5) | 29 (72.5) | 0.667 | 1.00 |
None/Not clear | 6 (15) | ||||
Non industry | 2 (5) | ||||
Head Circumference N = 31 | Industry | 4 (12.9) | 23 (74.2) | 0.712 | 1.00 |
None /Not clear | 3 (9.7) | ||||
Non industry | 1 (3.2) |
Tolerance | Source of funding | Positive* | Negative* | Neutral* | Chi-square p value | Fisher’s exact p value |
---|---|---|---|---|---|---|
n (%)$$
| n (%)$$
| n (%)$$
| ||||
Colic N = 13 | Industry | 1 (7.7) | 11 (84.6) | 0.764 | 1.00 | |
None/Not clear | ||||||
Non industry | 1 (7.7) | |||||
Spitting up/Regurgitation N = 26 | Industry | 2 (7.7) | 1 (3.8) | 17 (65.4) | 0.907 | 1.00 |
None/Not clear | 4 (15.4) | |||||
Non industry | 2 (7.7) | |||||
Vomiting N = 31 | Industry | 1 (3.2) | 23 (74.2) | 0.860 | 1.00 | |
None/Not clear | 5 (16.1) | |||||
Non industry | 2 (6.5) | |||||
Crying fussiness N =22 | Industry | 3 (13.6) | 1 (4.5) | 14 (63.6) | 0.581 | 1.00 |
None/Not clear | 4 (18.2) | |||||
Non industry | 0 | |||||
Gastric residuals, Abdominal distension N = 5 | Industry | 1 (20) | 0.659 | 1.00 | ||
None/Not clear | 1 (20) | |||||
Non industry | 1 (6.7) | 2 (40) | ||||
Volume of formula consumed/daily intake N = 31 | Industry | 3 (9.7) | 1 (3.2) | 18 (58.1) | 0.758 | 1.00 |
None/Not clear | 4 (12.9) | |||||
Non industry | 5 (16.1) | |||||
Days to full enteral feeding N = 9 | Industry | 4 (44.4) | 0.325 | 0.444 | ||
None/Not clear | 1 (11.1) | 1 (11.1) | ||||
Non industry | 1 (11.1) | 2 (22.2) |
Stool characteristics | Source of funding | Positive* | Negative* | Neutral* | Chi-square p value | Fisher’s exact p value |
---|---|---|---|---|---|---|
n (%)$$
| n (%)$$
| n (%)$$
| ||||
Stool Frequency N = 37 | Industry | 7 (18.9) | 22 (59.5) | 0.501 | 0.540 | |
None/Not clear | 3 (8.1) | 4 (10.8) | ||||
Non industry | 1 (2.7) | |||||
Stool Consistency n =37 | Industry | 14 (37.8) | 15 (40.5) | 0.562 | 1.00 | |
None/Not clear | 4 (10.8) | 3 (8.1) | ||||
Non industry | 1 (2.7) | |||||
Stool pH N =13 | Industry | 7 (53.8) | 2 (15.4) | 0.305 | 1.00 | |
None/Not clear | 4 (30.8) | |||||
Non industry | ||||||
Stool Short Chain Fatty Acids N = 9 | Industry | 2 (22.2) | 4 (44.4) | 0.687 | 1.00 | |
None / Not clear | 1 (11.1) | 1 (11.1) | ||||
Non industry | 1 (11.1) | |||||
Flatulence / Gas N = 16 | Industry | 15 (93.8) | Not valid | |||
None/Not clear | 1 (6.3) | |||||
Non industry | 0 | |||||
Diarrhoea, Diarrhoea episodes N = 19 | Industry | 3 (15.8) | 1 (5.3) | 10 (52.6) | 0.771 | 1.00 |
None/Not clear | 2 (10.5) | |||||
Non industry | 3 (15.8) | |||||
Constipation N = 3 | Industry | 1 (33.3) | 1 (33.3) | 0.386 | 1.00 | |
None/Not clear | 1 (33.3) | |||||
Non industry | 0 |
Microflora | Source of funding | Positive 4* | Negative 5* | Neutral 6* | Chi-square p value | Fisher’s exact p value |
---|---|---|---|---|---|---|
n (%)$$
| n (%)$$
| n (%)$$
| ||||
Bifidobacteria N = 31 | Industry | 12 (38.7) | 6 (19.4) | 0.416 | 0.583 | |
None/Not clear | 8 (25.8) | 2 (6.5) | ||||
Non industry | 3 (9.7) | |||||
Lactobacillus N = 19 | Industry | 2 (10.5) | 6 (31.6) | 0.155 | 0.176 | |
None/Not clear | 4 (21.1) | 5 (26.3) | ||||
Non industry | 2 (10.5) | 0 | ||||
Pathogens N = 25 | Industry | 2 (8.0) | 11 (44.0) | 0.532 | 0.612 | |
None/Not clear | 3 (12.0) | 1 (4.0) | 6 (24.0) | |||
Non industry | 2 (8.0) |
Source of funding | Positive* | Neutral* | Chi-square p value | Fisher’s exact p value | |
---|---|---|---|---|---|
n (%)$$
| n (%)$$
| ||||
Necrotising enterocolitis N = 11 | Industry | 4 (36.4) | 0.118 | 0.273 | |
None/Not clear | 3 (27.3) | ||||
Non industry | 2 (18.2) | 2 (18.2) | |||
Sepsis N = 10 | Industry | 2 (20) | Not Valid | ||
None/Not clear | 3 (30) | ||||
Non industry | 5 (50) | ||||
Antibiotic use N = 19 | Industry | 4 (21.1) | 4 (21.1) | 0.031#
| 0.039#
|
None/Not clear | 5 (26.3) | ||||
Non industry | 6 (31.6) |
Association between source of funding (sponsor) and overall study conclusion
Source of funding | Positive | Negative | Neutral | No clear conclusion | Total | Chi-square p value | Fisher’s exact p value | |
---|---|---|---|---|---|---|---|---|
n (%)$$
| n (%)$$
| n (%)$$
| n (%)$$
| n (%)$$
| ||||
Overall conclusion N = 67 | Industry | 32 (47.8) | 2 (3.0) | 3 (4.5) | 3 (4.5) | 40 (59.7%) | 0.505 | 0.373 |
None/Not clear | 10 (14.9) | 3 (4.5) | 2 (3.0) | 1 (1.5) | 16 (23.9%) | |||
Non industry | 7 (10.4) | 2 (3.0) | 2 (3.0) | 0 | 11 (16.4%) | |||
Total | 49 (73.1%) | 7 (10.4%) | 7 (10.4%) | 4 (6.0%) | 67 (100) |
Association between source of funding (sponsor) and conclusion on reported clinical outcomes
Authors conclusion on: | Source of funding | No conclusion on reported outcome | Positive | Negative | Chi-square p value | Fisher’s exact p value |
---|---|---|---|---|---|---|
n (%)$$
| n (%)$$
| n (%)$$
| ||||
Weight gain N = 56 | Industry | 23 (41.1%) | 14 (25.0%) | 0.037#
| 0.024#
| |
None/Not clear | 10 (17.9%) | 1 (1.8%) | 1 (1.8%) | |||
Non industry | 7 (12.5%) | |||||
Length gain N = 40 | Industry | 18 (45%) | 14 (35%) | 0.068 | 0.051 | |
None/Not clear | 6 (15%) | |||||
Non industry | 2 (5) | |||||
Head circumference N = 31 | Industry | 13 (41.9) | 14 (45.2) | 0.151 | 0.232 | |
None/Not clear | 3 (9.7) | |||||
Non industry | 1 (3.2) |
Tolerance | Source of funding | No conclusion on reported outcome | Positive | Negative | Chi-square p value | Fisher’s exact p value |
---|---|---|---|---|---|---|
n (%)$$
| n (%)$$
| n (%)$$
| ||||
Colic N = 13 | Industry | 10 (76.9) | 2 (15.4) | 0.657 | 1.00 | |
None/Not clear | ||||||
Non industry | 1 (7.7) | |||||
Spitting up/Regurgitation N = 26 | Industry | 19 (73.1) | 1 (3.8) | 0.032 | 0.062 | |
None/Not clear | 2 (7.7) | 2 (7.7) | ||||
Non industry | 2 (7.7) | |||||
Vomiting N = 32 | Industry | 19 (59.4) | 5 (15.6) | |||
None/Not clear | 3 (9.4) | 3 (9.4) | ||||
Non industry | 2 (6.3) | |||||
Crying Fussiness N =20 | Industry | 10 (50) | 6 (30) | 0.648 | 1.00 | |
None/Not clear | 2 (10) | 2 (10) | ||||
Non industry | 0 | |||||
Gastric residuals, Abdominal distension N = 6 | Industry | 1 (16.7) | 0.513 | 1.00 | ||
None/Not clear | 1 (16.7) | 1 (16.7) | ||||
Non industry | 2 (33.3) | 1 (16.7) | ||||
Volume of formula consumed/daily intake N = 30 | Industry | 19 (63.3) | 2 (6.7) | 1 (3.3) | 0.867 | 0.733 |
None/Not clear | 3 (10.0) | |||||
Non industry | 4 (13.3) | 1 (3.3) | ||||
Days to full enteral feeding N = 8 | Industry | 2 (25) | 1 (12.5) | 0.547 | 1.00 | |
None/Not clear | 1 (12.5) | 1 (12.5) | ||||
Non industry | 2 ()25 | 1 (12.5) |
Stool characteristics | Source of funding | No conclusion on reported outcome | Positive | Negative | Pearson’s chi Square | Fisher’s exact p value |
---|---|---|---|---|---|---|
n (%)$$
| n (%)$$
| n (%)$$
| ||||
Stool frequency N = 38 | Industry | 21 (55.3) | 9 (23.7) | 0.809 | 1.00 | |
None / Not clear | 5 (13.2) | 2 (5.3) | ||||
Non industry | 1 (2.6) | |||||
Total | 27 (71.1) | 11 (28.9) | ||||
Stool consistency n =39 | Industry | 18 (46.2) | 13 (33.3) | 0.699 | 1.00 | |
None / Not clear | 4 (10.3) | 3 (7.7) | ||||
Non industry | 1 (2.6) | |||||
Total | 23 (59) | 16 (41) | ||||
Stool pH N =12 | Industry | 5 (41.7) | 3 (25) | 0.679 | 1.00 | |
None / Not clear | 2 (16.7) | 2 (16.7) | ||||
Non industry | ||||||
Total | 7 (58.3) | 5 (41.7) | ||||
Stool short chain fatty acids N = 9 | Industry | 3 (33.3) | 3 (33.3) | 0.638 | 1.00 | |
None / Not clear | 1 (11.1) | 1 (11.1) | ||||
Non industry | 1 (11.1) | |||||
Total | 5 (55.6) | 4 (44.4) | ||||
Flatulence/Gas N = 15 | Industry | 10 (66.7) | 4 (26.7) | 0.533 | 1.00 | |
None / Not clear | ||||||
Non industry | 1 (6.7) | |||||
Total | 11 (73.3) | 4 (26.7) | ||||
Diarrhoea, Diarrhoea episodes N = 18 | Industry | 7 (38.9) | 5 (27.8) | 1 (5.6) | 0.484 | 0.557 |
None / Not clear | 2 (11.1) | |||||
Non industry | 3 (16.7) | |||||
Total | 12 (66.7) | 5 (27.8) | 1 (5.6) | |||
Constipation N = 4 | Industry | 2 (50) | 1 (25) | 0.505 | 1.00 | |
None / Not clear | ||||||
Non industry | 1(25) | |||||
Total | 3 (75) | 1 (25) | 1 (25) |
Microflora | Source of funding | No conclusion on reported outcome | Positive | Negative | Neutral | Chi-square p value | Fisher’s exact p value |
---|---|---|---|---|---|---|---|
n (%)$$
| n (%)$$
| n (%)$$
| n (%)$$
| ||||
Bifidobacteria N = 30 | Industry | 7 (23.3) | 11 (36.7) | 0.249 | 0.195 | ||
None/Not clear | 2 (6.7) | 5 (16.7) | 1 (3.3) | 1 (3.3) | |||
Non industry | 1 (3.3) | 1 (3.3) | 1 (3.3) | ||||
Lactobacillus N = 19 | Industry | 5 (26.3) | 4 (21.1) | 0.084 | 0.294 | ||
None/Not clear | 3 (15.8) | 4 (21.1) | 1 (5.3) | ||||
Non industry | 1 (5.3) | 1 (5.3) | |||||
Pathogens N = 25 | Industry | 7 (28) | 6 (24) | 0.152 | 0.269 | ||
None/Not clear | 4 (16) | 5 (20) | 1 (4) | ||||
Non industry | 1 (4) | 1 (4) |
Source of funding | No conclusion on reported outcome | Positive | Negative | Pearson’s chi Square | Fisher’s exact p value | |
---|---|---|---|---|---|---|
n (%)$$
| n (%)$$
| n (%)$$
| ||||
NEC N = 12 | Industry | 3 (25) | 1 (8.3) | 0.511 | 0.782 | |
None/Not clear | 2 (16.7) | 1 (8.3) | 1 (8.3) | |||
Non industry | 2 (16.7) | 2 (16.7) | 0 | |||
7 (58.3) | 3 (25) | 2 (16.7) | ||||
Sepsis N = 10 | Industry | 2 (20) | 0.274 | 0.500 | ||
None/Not clear | 2 (20) | 1 (10) | ||||
Non industry | 5 (50) | |||||
Antibiotic use N = 16 | Industry | 4 (25) | 3 (18.8) | 0.093 | 0.141 | |
None/Not clear | 4 (25) | |||||
Non industry | 5 (31.3) |