Bovine colostrum for prevention of recurrent urinary tract infections in susceptible children: A randomized controlled trial

Table 1 Baseline characteristics in study groups, n (%)/mean ± SD

Variables	Colostrum group (n = 30)	Placebo group (n = 30)	P value
Age (years)	5.1 ± 3.3	4.8 ± 3.2	0.685
Male	18 (60.0)	20 (66.7)	0.592
Weight	-0.8 ± 1.2	-1.1 ± 1.6	0.454
Height	-1.1 ± 1.5	-1.3 ± 1.9	0.607
Pathology
Posterior urethral valve	14 (46.7)	17 (56.7)	0.438
Pelvi-ureteric junction obstruction	4 (13.3)	2 (6.7)	0.671
Vesicoureteric reflux	7 (23.3)	9 (30.0)	0.559
Single kidney	5 (16.7)	2 (6.7)	0.424
Neurogenic bladder	1 (3.3)	1 (3.3)	0.999
Antibiotic prophylaxis	24 (80.0)	26 (86.7)	0.488
Creatinine (mg/dL)	0.8 ± 0.4	0.9 ± 0.8	0.651
eGFR (mL/minute/1.73 m2)	67.2 ± 28.8	73.2 ± 40.8	0.513
Chronic kidney disease stage
I	4 (13.3)	9 (30.0)	0.292
II	11 (36.7)	8 (26.7)
III	13 (43.3)	9 (30.0)
IV	2 (6.7)	2 (6.7)
V	0 (0.0)	2 (6.7)

eGFR: Estimated glomerular filtration rate.

Table 2 Frequency of cystitis/pyelonephritis among study groups, n (%)

Time	Colostrum group (n = 30)	Placebo group (n = 30)	P value	RR (95%CI)
Pyelonephritis/cystitis
Month-1	10 (33.3)	14 (46.7)	0.292	0.71 (0.38-1.35)
Month-2	7 (23.3)	12 (40.0)	0.165	0.58 (0.27-1.28)
Month-3	5 (16.7)	9 (30.0)	0.222	0.56 (0.21-1.46)
Month-4	3 (10.0)	11 (36.7)	0.015	0.27 (0.08-0.88)
Month-5	3 (10.0)	12 (40.0)	0.007	0.25 (0.08-0.80)
Month-6	3 (10.0)	11 (36.7)	0.015	0.27 (0.08-0.88)
Incidence	17 (56.7)	23 (76.7)	0.222	0.84 (0.63-1.12)
Cystitis
Month-1	5 (16.7)	8 (26.7)	0.347	0.63 (0.23-1.69)
Month-2	5 (16.7)	7 (23.3)	0.519	0.71 (0.25-2.00)
Month-3	2 (6.7)	5 (16.7)	0.424	0.40 (0.08-1.90)
Month-4	1 (3.3)	7 (23.3)	0.052	0.14 (0.02-1.09)
Month-5	2 (6.7)	7 (23.3)	0.145	0.29 (0.06-1.26)
Month-6	2 (6.7)	7 (23.3)	0.145	0.29 (0.06-1.26)
Incidence	13 (43.3)	21 (70.0)	0.037	0.62 (0.39-0.99)
Pyelonephritis
Month-1	5 (16.7)	6 (20.0)	0.739	0.83 (0.28-2.44)
Month-2	2 (6.7)	5 (16.7)	0.424	0.40 (0.08-1.90)
Month-3	3 (10.0)	4 (13.3)	0.999	0.75 (0.18-3.07)
Month-4	2 (6.7)	4 (13.3)	0.677	0.50 (0.10-2.53)
Month-5	1 (3.3)	5 (16.7)	0.195	0.20 (0.02-1.61)
Month-6	1 (3.3)	4 (13.3)	0.353	0.25 (0.03-2.11)
Incidence	14 (46.7)	14 (46.7)	0.999	1.00 (0.58-1.72)

RR: Relative risk.

Table 3 Frequency of sterile pyuria among study groups, n (%)

Time	Colostrum group (n = 30)	Placebo group (n = 30)	P value	RR (95%CI)
Month-1	5 (16.7)	6 (20.0)	0.739	0.83 (0.28-2.44)
Month-2	3 (10.0)	6 (20.0)	0.472	0.50 (0.14-1.82)
Month-3	2 (6.7)	8 (26.7)	0.038	0.25 (0.06-1.08)
Month-4	3 (10.0)	7 (23.3)	0.166	0.43 (0.12-1.50)
Month-5	1 (3.3)	6 (20.0)	0.103	0.17 (0.02-1.30)
Month-6	1 (3.3)	5 (16.7)	0.195	0.20 (0.02-1.61)
Incidence	12 (40.0)	19 (63.3)	0.071	0.63 (0.38-1.06)

RR: Relative risk.

Table 4 Frequency of asymptomatic bacteriuria among study groups, n (%)

Time	Colostrum group (n = 30)	Placebo group (n = 30)	P value	RR (95%CI)
Month-1	0 (0.0)	2 (6.7)	0.492	Not applicable
Month-2	3 (10.0)	2 (6.7)	0.999	1.50 (0.27-8.34)
Month-3	1 (3.3)	6 (20.0)	0.103	0.17 (0.02-1.30)
Month-4	0 (0.0)	5 (16.7)	0.052	Not applicable
Month-5	1 (3.3)	2 (6.7)	0.999	0.50 (0.05-5.22)
Month-6	1 (3.3)	5 (16.7)	0.195	0.20 (0.02-1.61)
Incidence	5 (16.7)	14 (46.7)	0.012	0.36 (0.15-0.87)

RR: Relative risk.

Table 5 Frequency of gastrointestinal and respiratory infection among study groups, n (%)

Time	Colostrum group (n = 30)	Placebo group (n = 30)	P value	RR (95%CI)
GIT/respiratory infections
Month-1	15 (50.0)	12 (40.0)	0.436	1.25 (0.71-2.20)
Month-2	3 (10.0)	18 (60.0)	< 0.001	0.17 (0.05-0.51)
Month-3	4 (13.3)	14 (46.7)	0.005	0.29 (0.11-0.77)
Month-4	4 (13.3)	13 (43.3)	0.010	0.31 (0.11-0.84)
Month-5	3 (10.0)	17 (56.7)	< 0.001	0.18 (0.06-0.54)
Month-6	3 (10.0)	11 (36.7)	0.015	0.27 (0.08-0.88)
Incidence	19 (63.3)	29 (96.7)	0.001	0.66 (0.50-0.87)
GIT infections
Month-1	7 (23.3)	6 (20.0)	0.754	1.17 (0.44-3.06)
Month-2	2 (6.7)	9 (30.0)	0.020	0.22 (0.05-0.94)
Month-3	1 (3.3)	7 (23.3)	0.052	0.14 (0.02-1.09)
Month-4	2 (6.7)	5 (16.7)	0.424	0.40 (0.08-1.90)
Month-5	1 (3.3)	8 (26.7)	0.026	0.13 (0.02-0.94)
Month-6	1 (3.3)	5 (16.7)	0.195	0.20 (0.02-1.61)
Incidence	9 (30.0)	18 (60.0)	0.020	0.50 (0.27-0.93)
Respiratory infection
Month-1	8 (26.7)	6 (20.0)	0.542	1.33 (0.53-3.38)
Month-2	1 (3.3)	9 (30.0)	0.006	0.11 (0.01-0.82)
Month-3	3 (10.0)	7 (23.3)	0.166	0.43 (0.12-1.50)
Month-4	2 (6.7)	8 (26.7)	0.038	0.25 (0.06-1.08)
Month-5	2 (6.7)	9 (30.0)	0.020	0.22 (0.05-0.94)
Month-6	2 (6.7)	6 (20.0)	0.254	0.33 (0.07-1.52)
Incidence	14 (46.7)	23 (76.7)	0.017	0.61 (0.40-0.94)

RR: Relative risk; GIT: Gastrointestinal.