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.