. 2022 Mar 29;55(9):1116–1127. doi: 10.1111/apt.16914

TABLE 1.

Baseline demographic and clinical characteristics

	Period 1 Gluten N = 17	Period 1 Placebo N = 16	Baseline total combined
Basic characteristics
Age, years ^a	19.8 [18.9;20.8]	20.5 [20.1;20;9]	20.3 [19.2;20;9]
Sex, females (n%) ^b	17 (100%)	16 (94%)	32 (97%)
Height, SD‐score ^c	−0.7 [−1.0;0.7]	−0.5 [−1.1;0.1]	−0.4 [−1.1;0.5]
Weight, SD‐score ^c	0.0 [−0.4;0.9]	−0.5 [−1.1;0.3]	−0.1 [−0.7;0.6]
Body‐Mass‐Index (BMI) kg/m^2, ^d	22.7 [21.0;24.4]	21.6 [20.6;24.4]	22.0 [20.6;24.4]
BMI, SD‐score ^c	0.4 [0.0;1.3]	0.1 [−0.7;1.1]	0.3 [−0.1;1.2]
Number of gastrointestinal symptoms (at least 4 out of 10) ^e	5 [4;6]	5 [4;6]	5 [4;6]
IgE Wheat positive (n%) ^f	0 (0%)	4 (25%)*	4 (12%)
On diet to obtain weight loss (n%) ^g	5 (29%)	0 (0%)*	5 (15%)
Medication, fasting, or vomiting to obtain weight loss (n%) ^h	2 (12%)	0 (0%)	2 (6%)
Wanting to be thin or afraid of weight gain (n%) ⁱ	12 (71%)	14 (88%)	26 (79%)
Exercising to obtain weight loss (n%) ^j	11 (65%)	10 (63%)	21 (64%)
Autoimmune disease among first‐degree relatives (n%) ^j	0 (0%)	2 (13%)	2 (6%)
HLA status, positive HLA DQ2 / DQ8 (n%)	11 (65%)	7 (47%)	18 (55%)
Primary outcome
VAS Symptom Score at baseline, 0‐100 mm	19 [6–26]	21 [14–29]	21 [9–29]
VAS symptom Score at the beginning at Phase 1, 0‐100 mm	55 [50–61]	54 [43–60]	55 [43–61]
Key secondary outcomes
SF‐36 Mental Component Score, score: 0‐100 ^k	48.1 (10.9)	45.9 (11.8)	47.0 (11.2)
SF‐36 Physical Component Score, score: 0‐100 ^k	53.3 (8.2)	51.5 (8.0)	52.4 (8.0)
WEMWBS: 14‐70 ^k	52.1 (5.2)	50.1 (8.0)	51.1 (6.8)
Other secondary outcomes
VAS₁, / Abdominal pain, 0‐100 mm	4 [0–38]	18 [3–23]	16.5 [0–28]
VAS₂, / Bloating, 0‐100 mm	19 [9–29]	22 [10–35]	19 [10–31]
VAS₃ / Flatulence, 0‐100 mm	24 [16–17]	38 [24–44]	27 [19–44]
VAS₄, / Borborygmi, 0‐100 mm	20 [11–49]	28 [15–75]	26 [11–57]
VAS₅, / Diarrhoea, 0‐100 mm	0 [0–10]	10 [0–29]	2 [0–23]
VAS₆, / Constipation, 0‐100 mm	11 [0–34]	18 [0–43]	17 [0–39]
VAS₇, / Incomplete evacuation after toilet visit, 0‐100 mm	11 [0–33]	31 [17–56]	23 [0–42]
VAS₈, / Nausea, 0‐100 mm	14 [0–28]	8 [0–14]	10 [0–26]
VAS₉, / Burping, 0‐100 mm	1 [0–17]	4 [0–14]	0 [0–16]
VAS₁₀, / dyspepsia, 0‐100 mm	0 [0–4]	2 [0–13]	0 [0–13]

Note: Values are means ± SDs, or median and interquartile range (depending on the empirical data distribution); unless otherwise stated. Significant differences (p < 0.05) are marked with an asterisk (*).

^{^a}

The age was calculated as the age of the participants on September 1, 2020.

^{^b}

Based on the Danish personal identification number.

^{^c}

Height, weight, and BMI were reported as SD scores to allow for age and sex using the Danish references for growth. ⁴⁹ The values are obtained from the Glutenfunen cohort, including participants from 2018 to 2020.

^{^d}

Based on the questionnaire to the participants in the Glutenfunen cohort. The score reflects the number of gastrointestinal symptoms, with the maximum being 10. To be included in this study, a symptom score higher than 3 was necessary.

^{^e}

The values are obtained from the Glutenfunen cohort, including participants from 2018 to 2020.

^{^f}

IgE wheat was measured at day 0. Higher than 0.35 kU/l was considered positive

^{^g}

Was considered positive if the participants answered “every day,” “often,” or “several times” and negative if participants answered “a couple of times,” “never,” or “do not know.” The time scale was the last year.

^{^h}

Was considered positive if the participants answered “every day,” “several times per week,” “once a week,” or “1‐3 times per month,” and negative if they answered “never,” “do not know,” or “less than once per month.”

^ⁱ

Was considered positive if the participants answered “every day,” “often,” or “sometimes,” and it was considered negative if they answered, “rarely,” “never,” or “do not know.”

^{^j}

Based on the questionnaire to the participants in the GlutenFunen cohort.

^{^k}

Measured at day 0.