Effects of carob-bean gum thickened formulas on infants’ reflux and tolerance indices

Table 1 Changes in “non-symptom related” 24 h pH monitoring indices from baseline to follow-up examination by study group

	Baseline		Follow up		2-wk change		P-value(treatment x time)
	Mean	(SD)	Mean	(SD)	Mean change	(95%CI)
Reflux Index (%)							0.484
Formula A (n = 16)	11.4	-10.3	8.97	-8.23	-2.52	(-9.48 to 4.45)
Formula B (n = 15)	6.47	-5.67	10.1	-13.1	3.44	(-3.85 to 10.7)
Formula C (n = 16)	10.3	-12.6	9.42	-10.2	-0.67	(-7.77 to 6.44)
P value (Treatment effect)	0.247		0.901
Longest reflux (min)							0.445
Formula A (n = 16)	19.3	-15.4	13.9	-8.69	-5.16	(-13.8 to 3.48)
Formula B (n = 15)	15.7	-18.4	11.8	-7.27	-3.31	(-12.3 to 5.73)
Formula C (n = 16)	14.4	-9.47	17.6	-16.6	2.48	(-6.32 to 11.3)
P value (Treatment effect)	0.664	0.219
Total time below pH 4 (min)							0.722
Formula A (n = 16)	12.2	-12.1	7.85	-7.64	-4.5	(-13.6 to 4.58)
Formula B (n = 15)	11.5	-20.3	10.3	-13.1	-1.7	(-11.2 to 7.80)
Formula C (n = 16)	9.66	-12.9	9.84	-10.3	0.72	(-8.54 to 9.98)
P value (Treatment effect)	0.944		0.655
Reflux below pH 4 for more than 5 min (n/d)							0.712
Formula A (n = 16)	6.42	-7.19	4.6	-5.21	-1.76	(-5.89 to 2.38)
Formula B (n = 15)	4.08	-4.28	4.33	-4.83	0.48	(-3.85 to 4.80)
Formula C (n = 16)	5.53	-8.34	5.96	-5.86	0.15	(-4.06 to 4.37)
P value (Treatment effect)	0.446		0.452
Boix Ochoa Score1							0.198
Formula A (n = 16)	107.6	-163	36.6	-29.4	-72.03	(-131.6 to -12.5)3
Formula B (n = 15)	53	-78.1	45	-41.8	-12.3	(-74.6 to 50.0)
Formula C (n = 16)	57.2	-80.7	52.1	-49.8	-0.08	(-60.8 to 60.7)
P value (Treatment effect)	0.346		0.381
Total refluxes per day (n/d)2							0.385
Formula A (n = 16)	377.3	-524.5	142.9	-118	-231.83	(-437.9 to -25.8)3
Formula B (n = 15)	169.3	-217	128	-97	-30.9	(-246.6 to 184.8)
Formula C (n = 16)	307.3	-475.4	220.4	-266.8	-99.2	(-309.5 to 111.1)
P value (Treatment effect)	0.343		0.234

¹Global measure of esophageal acid exposure;

²Indicative of the total number of visible and measurable refluxes during the 24 h monitoring;

³Indicate statistical significant findings. The “non-symptom related” 24 h pH monitoring indices include those indices recorded during the 24 h pH monitoring procedure, not requiring caregiver’s interference by pressing the “event button. Adjustment was made for the average volume of milk consumed by infants per day during the intervention period.

Table 2 Changes in “symptom related” 24 h pH monitoring indices from baseline to follow-up examination by study group

	Baseline		Follow up		2-wk change		P-value(treatment x time)
	Mean	(SD)	Mean	(SD)	Mean change	(95%CI)
Symptom index for reflux (SI)							0.0483
Formula A (n = 16)	39.7	-26.2	21.6	-14.5	-18.23	(-31.8 to -4.57)3
Formula B (n = 15)	24.5	-27.2	19.7	-20.8	-5.21	(-19.5 to 9.03)
Formula C (n = 16)	27.7	-20.6	33.7	-24.8	6.49	(-7.39 to 20.4)
P value (Treatment effect)	0.213		0.119
Symptom association probability1							0.096
Formula A (n = 16)	87.4	-25.2	49.5	-42.5	-37.93	(-64.6 to -11.3)3
Formula B (n = 15)	54.6	-47.3	58.7	-40.2	3.82	(-24.1 to 31.7)
Formula C (n = 16)	82.9	-33.8	57.8	-38.3	-24.8	(-52.0 to 2.37)
P value (Treatment effect)	0.031		0.762
Percentage of acid refluxes2 (%)							0.067
Formula A (n = 16)	39.8	-26.1	22.6	-15.0	-17.23	(-30.8 to -3.66)3
Formula B (n = 15)	24.6	-27.3	19.4	-20.8	-5.53	(-19.7 to 8.65)
Formula C (n = 16)	27.7	-20.4	33.3	-25.3	5.93	(-7.89 to 19.8)
P value (Treatment effect)	0.21		0.152
Percentage of all reflux (%)							0.0143
Formula A (n = 16)	47.9	-22.3	31.0	-18.1	-16.93	(-31.3 to -2.28)3
Formula B (n = 15)	35.1	-23.6	36.8	-28.7	1.78	(-13.3 to 16.9)
Formula C (n = 16)	33.7	-22.3	48.2	-28.8	14.4	(-0.28 to 29.2)
P value (Treatment effect)	0.167		0.201

¹Probability that symptom and reflux are not associated solely by chance;

²Percentage of acid refluxes out of the total number of refluxes occurring during the 24 h monitoring;

³Indicate statistical significant findings. The “symptom related” 24 h pH monitoring indices include those indices recorded during the 24 h pH monitoring procedure requiring caregiver’s interference by pressing the “event button”. Adjustment was made for the average volume of milk consumed by infants per day during the intervention period.

Table 3 Changes in growth and tolerance indices from baseline to follow-up examination by study group

	Baseline		Follow up		2-wk change		P-value (treatment x time)
	Mean	(SD)	Mean	(SD)	Mean change	(95%CI)
Growth indices
Weight (kg)							0.648
Formula A (n = 16)	5.8	-1.34	6.37	-1.11	0.573	(0.14 to 0.99)3
Formula B (n = 15)	5.36	-1.44	5.91	-1.37	0.51	(-0.06 to 0.96)
Formula C (n = 16)	5.33	-1.73	6.06	-0.97	0.793	(0.35 to 1.22)3
P value (Treatment effect)	0.355		0.40
Length (cm)							0.917
Formula A (n = 16)	61.2	-5.57	63.2	-5.07	1.933	(0.59 to 3.27)3
Formula B (n = 15)	59.4	-6.23	61.5	-6.02	2.073	(0.67 to 3.48)3
Formula C (n = 16)	60.2	-3.76	62.5	-3.53	2.333	(0.96 to 3.70)3
P value (Treatment effect)	0.543		0.631
Tolerance indices
Total number (3 d) of hard stools1							0.723
Formula A (n = 16)	0.5	-2.00	0.48	-1.07	-0.01	(-0.81 to 0.79)
Formula B (n = 15)	0.2	-0.56	0.55	-1.45	0.4	(-0.44 to 1.24)
Formula C (n = 16)	0.13	-0.50	0.17	-0.47	-0.02	(-0.83 to 0.80)
P value (Treatment effect)	0.62		0.291
Total number (3 d) of diarrheic defecations2							0.0153
Formula A (n = 16)	8.38	-11.6	5.31	-5.63	-2.88	(-7.91 to 2.16)
Formula B (n = 15)	5.6	-4.81	10.3	-10.1	5.473	(0.0 to 10.7)3
Formula C (n = 16)	11.1	-10.7	6.77	-6.68	-5.3	(-10.4 to -0.16)
P value (Treatment effect)	0.163		0.176
Total number of defecations (3 d)							0.0033
Formula A (n = 16)	10.7	-10.4	7.59	-4.23	-2.89	(-7.42 to 1.64)
Formula B (n = 15)	7.33	-3.81	12.5	-9.05	6.023	(1.28 to 10.8)3
Formula C (n = 16)	12.8	-9.39	8.07	-5.70	-5.723	(-10.3 to -1.10)3
P value (Treatment effect)	0.153		0.0403
Number of colics per day							0.569
Formula A (n = 16)	3.31	-2.72	1.34	-1.33	-1.993	(-3.02 to -0.95)3
Formula B (n = 15)	4.42	-2.44	1.59	-1.61	-1.873	(-2.96 to -0.79)3
Formula C (n = 16)	2.79	-1.55	1.5	-1.18	-1.243	(-2.30 to -0.19)3
P value (Treatment effect)	0.868		0.735

¹Hard stools are indicative of constipation and were corresponding to the Bristol stool chart types 1 and 2;

²Diarrheic defecations were corresponding to the Bristol stool chart types 5, 6 and 7;

³Indicate statistical significant findings. Adjustment was made for the average volume of milk consumed by infants per day during the intervention period.