Efficacy and palatability of the developed polyethylene glycol-based formula for the treatment of children with functional constipation

Table 1 Patient demographics and baseline characteristics (n = 52)

Variables	PEG-Chula(n = 26)	Commercial PEG(n = 26)
Age (years)	4.38 (2.90, 7.00)	3.92 (2.25, 9.91)
Age group (6 months-4 years)	11 (42.30)	14 (53.80)
Sex, males	11 (42.30)	6 (23.10)
Weight (kg)	16.1 (12.20, 25.20)	15.3 (11.50, 30.10)
Height (cm)	101 (90.00, 124.50)	97.75 (84.50, 135.00)
FC in family	15 (57.70)	16 (61.54)
Previous treatment for FC	14 (53.90)	11 (42.30)
Duration of constipation (months)	21 (12, 48)	16.5 (12, 30)
Frequency of defecation (time/week)	1.96 ± 0.58	2.21 ± 0.74
Stool consistency (Bristol Stool scale)	2.31 ± 0.78	2.08 ± 0.82
Painful defecation (Facial Pain scale)	3.65 ± 1.16	3.48 ± 1.01
Clogged toilet for toilet-trained children (n = 42)	13 (59.09)	10 (50.00)
Presence of fecal mass by examination	2 (7.69)	1 (3.85)
Blood coating the stool	11 (42.31)	8 (30.77)
Anal position index
Male	0.51 ± 0.06	0.5 ± 0.05
Female	0.38 ± 0.09	0.37 ± 0.06

Data were presented by mean ± SD, median (interquartile range) or n (%). FC: Functional constipation; PEG: Polyethylene glycol.

Table 2 Improvement of stool frequency and stool consistency

Variables	PEG-Chula group		Commercial group		Between group
	mean ± SD	Mean change from baseline (95%CI)	mean ± SD	Mean change from baseline (95%CI)	Mean difference (95%CI)	P value
Stool frequency (time/week)
Baseline (n = 52)	1.96 ± 0.58	-	2.21 ± 0.74	-	-	0.181
Week 1 (n = 51)	6.27 ± 2.97	4.31 (3.39-5.23)	6.16 ± 4.35	3.94 (2.95-4.94)	0.36 (-0.99 to 1.72)	0.597
Week 2 (n = 50)	6.20 ± 2.24	4.22 (3.29-5.15)	6.44 ± 3.98	4.22 (3.23-5.22)	-0.01 (-1.36 to 1.35)	0.993
Week 3 (n = 50)	5.92 ± 2.33	3.94 (3.01-4.87)	6.68 ± 3.8	4.46 (3.47-5.46)	-0.53 (-1.88 to 0.83)	0.448
Week 4 (n = 51)	6.08 ± 2.42	4.12 (3.20-5.03)	6.04 ± 3.88	3.82 (2.83-4.82)	0.29 (-1.06 to 1.64)	0.671
Week 5 (n = 51)	6.50 ± 2.67	4.54 (3.62-5.46)	6.20 ± 3.58	3.98 (2.99-4.98)	0.56 (-0.8 to 1.91)	0.420
Week 6 (n = 51)	6.35 ± 2.81	4.38 (3.47-5.3)	7.08 ± 3.5	4.86 (3.87-5.86)	-0.48 (-1.83 to 0.87)	0.488
Week 7 (n = 51)	6.35 ± 2.42	4.38 (3.47-5.3)	6.04 ± 2.91	3.82 (2.83-4.82)	0.56 (-0.79 to 1.91)	0.415
Week 8 (n = 50)	6.00 ± 2.14	4.02 (3.09-4.95)	6.00 ± 3.07	3.78 (2.79-4.78)	0.23 (-1.12 to 1.59)	0.736
Stool consistency
Baseline (n = 52)	2.31 ± 0.78	-	2.08 ± 0.82	-	-	0.30
Week 1 (n = 51)	4.17 ± 1.02	1.87 (1.55-2.18)	3.53 ± 1.15	1.45 (1.12-1.78)	0.41 (-0.04 to 0.87)	0.075
Week 2 (n = 50)	4.70 ± 0.74	2.40 (2.08-2.72)	4.01 ± 0.96	1.93 (1.61-2.26)	0.47 (0.01 to 0.93)	0.045
Week 3 (n = 50)	4.55 ± 0.92	2.24 (1.92-2.57)	3.96 ± 0.87	1.88 (1.56-2.21)	0.36 (-0.10 to 0.82)	0.123
Week 4 (n = 51)	4.65 ± 0.83	2.34 (2.02-2.66)	4.08 ± 0.78	2.00 (1.67-2.32)	0.34 (-0.11 to 0.80)	0.142
Week 5 (n = 51)	4.48 ± 0.54	2.17 (1.85-2.49)	4.15 ± 0.88	2.07 (1.74-2.40)	0.10 (-0.36 to 0.55)	0.675
Week 6 (n = 51)	4.36 ± 0.57	2.05 (1.73-2.37)	4.23 ± 0.79	2.16 (1.83-2.48)	-0.11 (-0.56 to 0.35)	0.650
Week 7 (n = 51)	4.30 ± 0.49	2.00 (1.68-2.31)	4.00 ± 0.88	1.92 (1.59-2.25)	0.08 (-0.38 to 0.53)	0.740
Week 8 (n = 50)	4.18 ± 0.38	1.87 (1.55-2.2)	4.10 ± 0.73	2.02 (1.69-2.34)	-0.14 (-0.60 to 0.32)	0.546

Data are presented by mean ± SD and mean change with 95%CI. PEG: Polyethylene glycol.

Table 3 Secondary outcome measures (n = 52)

Secondary end points	PEG-Chula	Commercial PEG	P value
Dose of PEG 4000 (g/kg) (n = 51)	0.58 (0.39, 0.63)	0.6 (0.38, 0.82)	0.62
Compliance (n = 51)	94.17 (88.60, 100)	90.1 (77.67, 98.10)	0.33
Days with defecations per week (n = 51)	5.19 ± 1.23	4.95 ± 1.54	0.52
Change from baseline of painful defecation (n = 51)	-2.41 ± 1.41	-1.87 ± 1.29	0.17
Withholding behaviours after treatment (n = 40)	3 (15.79)	8 (38.09)	0.161
Large stool diameter after treatment (n = 36)	2 (10.53)	1 (5.88)	11
Fecal incontinence after treatment (n = 6)	1 (20)	0 (0)	11
Abdominal pain after treatment (n = 13)	0 (0)	1 (16.67)	0.461
Bloating/flatulence after treatment (n = 11)	1 (11.11)	0 (0)	11
Appetite loss after treatment (n = 9)	0 (0)	1 (33.33)	0.331
Anal fissure after treatment (n = 22)	3 (25)	1 (10)	0.591
Fulfill Rome IV criteria for functional constipation after treatment (n = 51)	0	1 (4)	0.301
Fecal contents detected by transabdominal ultrasonography (n = 51)	8 (30.77)	7 (28)	0.82

¹Fisher’s exact test.

Data were presented by mean ± SD, median (interquartile range) or n (%). PEG: Polyethylene glycol.

Table 4 Palatability of the polyethylene glycol formula (n = 52)

Intervention group		Palatability	P value
PEG-Chula group	Strawberry	3.00 (2.50, 4.00)	0.12
	Lychee	4.00 (3.20, 5.00)	0.44
	Green apple	3.60 (2.60, 4.00)	0.27
	Lychee-rose	4.00 (3.00, 4.00)	0.80
	Most preferred flavor	4.30 (4.00, 5.00)	0.004
Commercial PEG group	Orange-grapefruit	3.90 (3.50, 4.10)	1

P value: Comparison between each flavor in polyethylene glycol (PEG)-Chula with the commercial PEG group. Data are presented by median (interquartile range). PEG: Polyethylene glycol.

Table 5 Adverse events during the intervention period (n = 52), n (%)

Adverse events	PEG-Chula (n = 26)	Commercial PEG (n = 26)
Number of patients who reported adverse events	5 (19.23)	3 (11.54)
Mild	5 (19.23)	3 (11.54)
Moderate	0	0
Severe	0	0
Any adverse events
Diarrhoea	3 (11.54)	2 (7.69)
Abdominal pain	2 (7.69)	1 (3.85)

PEG: Polyethylene glycol.