Moderate intakes of soluble corn fibre or inulin do not cause gastrointestinal discomfort and are well tolerated in healthy children

Figures & data

Figure 1. Study design.

Table 1. Test products.

Subject age range	Low-dose inulin	Low-dose Soluble Corn Fibre	High-dose inulin	High-dose Soluble Corn Fibre
3–5 years old	3 g fibre per day	3 g fibre per day	6 g fibre per day	6 g fibre per day
6–9 years old	5 g fibre per day	5 g fibre per day	8 g fibre per day	8 g fibre per day

Figure 2. Disposition of study participants.

Table 2. Selected subject demographic and anthropometric measures at screening for the mITT population.

Characteristic	Statistic/Category	mITT
Age (years)	N	43
	Mean (SD)	5.9 (2.2)
	SEM	0.3
	Median (Min, Max)	6 (3, 9)
	(Q1, Q3)	4, 8
Age Group	3–5 years	21 (48.8%)
	6–9 years	22 (51.2%)
Gender	Female	25 (58.1%)
	Male	18 (41.9%)
Ethnicity	Hispanic/latino	9 (20.9%)
	Not hispanic/latino	34 (79.1%)
Race	Asian	5 (11.6%)
	Black/African-American	7 (16.3%)
	More than one	1 (2.3%)
	White	30 (69.8%)
Height (cm)	Mean (SD)	117.9 (14.6)
	SEM	2.2
	Median (Min, Max)	113 (94, 147.1)
	(Q1, Q3)	106.2, 129.5
Weight (kg)	Mean (SD)	25.7 (9)
	SEM	1.4
	Median (Min, Max)	22.5 (13.7, 50.2)
	(Q1, Q3)	18.9, 30
BMI (kg/m^2)	Mean (SD)	18 (2.8)
	SEM	0.4
	Median (Min, Max)	17.4 (14.2, 24.7)
	(Q1, Q3)	15.7, 19.8
Composite GI symptom at baseline	None	22 (51.2%)
	Mild	18 (41.9%)
	Moderate	3 (7%)
Stool frequency at baseline	Mean (SD)	2.3 (1.7)
	Median (Min, Max)	2 (0, 7)
	(Q1, Q3)	1, 3
Stool consistency at baseline	Mean (SD)	3.2 (1.05)
	Median	3 (1.7, 6)
	(Q1, Q3)	2.5, 3.8

Abbreviations. BMI, body mass index; Max, maximum; Min, minimum; n, sample size; Q1, quartile 1; Q3, quartile 3; SD, standard deviation; SEM, standard error of the mean.

Table 3. Area under the curve (AUC) for the composite GI symptom score for the mITT population^a.

Source	Summary Statistic	SCF		Inulin
		High-dose (HSCF)	Low-dose (LSCF)	High-dose (IH)	Low-dose (IL)
Summary statistics^a	N	40	39	40	38
	Mean (SD)	6.8 (7.0)	7.3 (8.4)	9.0 (12.2)	6.9 (7.8)
	Median (Min, Max)	3.4 (0.0, 23.0)	5.0 (0.0, 34.0)	3.9 (0.0, 62.5)	5.1 (0.0, 30.8)
	(Q1, Q3)	0.1, 13.0	0.3, 12.2	0.0, 15.9	0.0, 13.3
Model (rank-based)	p-value LSCF vs IL	0.23
	p-value HSCF vs IH	0.37
	p-value LSCF vs HSCF	0.47

Abbreviations. Max, maximum; Min, minimum; n, sample size; Q1, quartile 1; Q3, quartile 3; SD, standard deviation.

^aAUC includes unplanned collection days based on when subjects responded to survey.

Table 4. Area under the curve (AUC) for the composite GI symptom score for the mITT population by age group^a.

Age group	Source	Summary statistic	SCF		Inulin
			High-dose (HSCF)	Low-dose (LSCF)	High-dose (IH)	Low-dose (IL)
3–5 years	Summary statistics^a	n	19	18	19	18
		Mean (SD)	4.6 (5.6)	6.5 (8.4)	9.0 (15.0)	5.7 (5.8)
		Median (Min, Max)	2.5 (0.0, 20.2)	4.9 (0.0, 34.0)	2.0 (0.0, 62.5)	5.8 (0.0, 15.2)
		(Q1, Q3)	0.0, 7.2	0.0, 10.0	0.0, 16.7	0.0, 10.5
	Model (rank-based)	p-value LSCF vs IL	0.42
		p-value HSCF vs IH	0.57
		p-value LSCF vs HSCF	0.25
6–9 years	Summary statistics^a	n	21	21	21	20
		Mean (SD)	8.7 (7.7)	8.0 (8.5)	8.9 (9.4)	7.9 (9.3)
		Median (Min, Max)	9.0 (0.0, 23.0)	5.0 (0.0, 26.3)	6.5 (0.0, 27.8)	3.3 (0.0, 30.8)
		(Q1, Q3)	0.2, 15.8	1.0, 13	0.0, 15.2	0.0, 15.5
	Model (rank-based)	p-value LSCF vs IL	0.79
		p-value HSCF vs IH	0.26
		p-value LSCF vs HSCF	0.93

Abbreviations. Max, maximum; Min, minimum; n, sample size; Q1, quartile 1; Q3, quartile 3; SD, standard deviation.

^aAUC includes unplanned collection days based on when subjects responded to survey.

Table 5. Model derived estimates of selected bacterial phylotypes for the mITT population.

Selected phylotype	Statistic^a	SCF		Inulin
		High-dose (HSCF)	Low-dose (LSCF)	High-dose (IH)	Low-dose (IL)
Anaerostipes^b	Estimate	0.017	0.016	0.028	0.023
	Confidence interval	0.014, 0.021	0.012, 0.020	0.023, 0.036	0.019, 0.029
	p-value HSCF vs IH	<0.001
	p-value LSCF vs IL	0.003
	p-value LSCF vs HSCF	0.504
Bifidobacterium^c	Estimate	0.035	0.048	0.097	0.059
	Confidence interval	0.005, 0.065	0.024, 0.072	0.073, 0.121	0.037, 0.082
	p-value HSCF vs IH	0.002
	p-value LSCF vs IL	0.475
	p-value LSCF vs HSCF	0.526
Fusicatenibacter	Estimate	0.030	0.023	0.016	0.018
	Confidence interval	0.026, 0.034	0.018, 0.027	0.012, 0.021	0.014, 0.023
	p-value HSCF vs IH	<0.001
	p-value LSCF vs IL	0.108
	p-value LSCF vs HSCF	0.018
Parabacteroides	Estimate	0.054	0.047	0.024	0.025
	Confidence interval	0.045, 0.062	0.039, 0.056	0.015, 0.033	0.017, 0.034
	p-value HSCF vs IH	<0.001
	p-value LSCF vs IL	<0.001
	p-value LSCF vs HSCF	0.235
Ruminococcaceae	Estimate	0.156	0.160	0.140	0.141
	Confidence interval	0.143, 0.168	0.148, 0.173	0.128, 0.153	0.129, 0.154
	p-value HSCF vs IH	0.068
	p-value LSCF vs IL	0.025
	p-value LSCF vs HSCF	0.593

^aModel adjusts for pre-intervention relative abundance and age stratification.

^bLog transformation used to model Anaerostipes and back-transformed values are presented.

^cDue to detected period effect for Bifidobacterium, only the first treatment period was analysed.

Data availability statement

The data presented in this study are available in the article or in the supplementary material.