Introduction
Material and methods
Population
Study products
Study protocol
NPT and clinical assessment
Nasal samples and immune markers
Blood samples and immune markers
Fecal samples
Statistical analysis
Results
Demographic and baseline data
n | Mean SD | Min | Max | |
---|---|---|---|---|
Age (years) | 31 | 26.8 3.7 | 20.2 | 34.6 |
Height (cm) | 31 | 173.8 7.3 | 161.0 | 190.0 |
Weight (kg) | 31 | 69.7 12.5 | 49.0 | 98.0 |
Body mass index (BMI, kg/m2) | 31 | 22.97 3.25 | 17.36 | 30.93 |
Compliance and safety
Before period A | After period A | Before period C | After period C | |||||
---|---|---|---|---|---|---|---|---|
Subject study number | A | B | A | B | A | B | A | B |
1
| ✓ | ✓ | ✓ | |||||
3
| ✓ | ✓ | ||||||
4
| ✓ | ✓ | ✓ | |||||
5
| ✓ | |||||||
6
| ✓ | ✓ | ||||||
7
| ✓ | ✓ | ||||||
8
| ✓ | ✓ | ||||||
9
| ✓ | ✓ | ✓ | |||||
10
| ✓ | ✓ | ||||||
11
| ✓ | ✓ | ||||||
12
| ✓ | ✓ | ✓ | |||||
13
| ✓ | |||||||
14
| ✓ | |||||||
15
| ✓ | ✓ | ||||||
16
| ✓ | ✓ | ||||||
17
| ✓ | ✓ | ||||||
18
| ✓ | ✓ | ||||||
19
| ✓ | ✓ | ||||||
20
| NS | NS | ||||||
21
| ✓ | ✓ | ✓ | |||||
22
| ✓ | ✓ | ||||||
23
| ✓ | ✓ | ||||||
24
| ✓ | ✓ | ||||||
26
| ✓ | ✓ | ||||||
29
| ✓ | ✓ | ✓ | |||||
30
| ✓ | ✓ | ||||||
31
| ✓ | ✓ | ✓ | |||||
32
| ✓ | ✓ | ||||||
33
| ✓ | ✓ | ✓ | |||||
34
| ✓ | NS | NS | NS | NS | |||
35
| ✓ | NS | NS | NS | NS |
Clinical outcomes
Nasal cell counts and immune markers
Cell mediated immunity markers
L. paracasei NCC2461 treatment
| ||||||||
---|---|---|---|---|---|---|---|---|
Allergen n n | Median | Rob. SD | SE median | Min. | Max. |
p -value
| ||
IL5 (pg/ml)
| NS | 29 | 0.00 | 0.77 | 0.18 | −69.61 | 6.96 | 0.92 |
MM | 29 | 26.58 | 83.51 | 19.44 | −79.91 | 462.69 | 0.09 | |
GR | 29 | 85.51 | 150.53 | 35.03 | −144.70 | 529.87 |
0.005
| |
IL8 (pg/ml)
| NS | 29 | 3328 | 20686 | 4814 | −137069 | 51061 | 0.45 |
MM | 29 | 51074 | 177356 | 41277 | −331659 | 489670 | 0.41 | |
GR | 29 | 85702 | 156506 | 36424 | −370412 | 1328885 |
0.004
| |
IL10 (pg/ml)
| NS | 29 | 0.00 | 0.46 | 0.11 | −1.04 | 2.48 | 0.89 |
MM | 29 | 1.80 | 4.80 | 1.12 | −5.93 | 16.14 |
0.01
| |
GR | 29 | 3.03 | 6.63 | 1.54 | −11.60 | 25.20 |
0.008
| |
IL13 (pg/ml)
| NS | 29 | 0.00 | 4.52 | 1.05 | −87.11 | 116.31 | 0.97 |
MM | 29 | 49.93 | 288.58 | 67.16 | −1000.90 | 1080.11 | 0.09 | |
GR | 29 | 266.00 | 332.54 | 77.39 | −466.57 | 908.99 |
0.001
| |
IFN-γ (pg/ml)
| NS | 29 | 0.00 | 0.00 | 0.00 | −106.58 | 169.48 | 0.86 |
MM | 29 | 1644.34 | 8456.16 | 1868.04 | −30350.99 | 43924.50 | 0.15 | |
GR | 29 | −165.66 | 1495.68 | 348.10 | −6365.44 | 10243.64 | 0.36 | |
Blend of
L. acidophilus
SD5221 and
B. lactis
SD5219 treatment
| ||||||||
Allergen n n
|
Median
|
Rob. SD
|
SE median
|
Min.
|
Max.
|
p
-value
| ||
IL5 (pg/ml)
| NS | 31 | 0.00 | 0.83 | 0.19 | −5.51 | 17.17 | 0.29 |
MM | 31 | 0.23 | 77.11 | 17.36 | −378.76 | 221.79 | 0.98 | |
GR | 31 | 29.36 | 170.38 | 38.35 | −674.14 | 1686.96 | 0.20 | |
IL8 (pg/ml)
| NS | 31 | 2353 | 22598 | 5087 | −240155 | 73699 | 0.84 |
MM | 31 | −26620 | 166240 | 37421 | −353181 | 1134834 | 0.85 | |
GR | 31 | −7132 | 153404 | 34532 | −1326885 | 300638 | 0.96 | |
IL10 (pg/ml)
| NS | 31 | 0.00 | 0.41 | 0.09 | −11.18 | 3.57 | 0.42 |
MM | 31 | 0.84 | 6.02 | 1.36 | −13.71 | 11.87 | 0.58 | |
GR | 31 | 0.60 | 5.95 | 1.34 | −14.84 | 17.89 | 0.75 | |
IL13 (pg/ml)
| NS | 31 | 0.00 | 0.794 | 0.18 | −10.672 | 70.676 |
0.04
|
MM | 31 | 59.10 | 322.66 | 72.63 | −1023.04 | 4155.62 | 0.42 | |
GR | 31 | 151.92 | 374.60 | 84 | −721.54 | 924.79 | 0.14 | |
IFN-γ (pg/ml)
| NS | 31 | 0.00 | 0.46 | 0.10 | −60.03 | 252.65 | 0.41 |
MM | 31 | −365.81 | 9372.17 | 2109.69 | −45256.46 | 21604.04 | 0.59 | |
GR | 31 | −200.91 | 1261.78 | 284.03 | −8287.66 | 3864.57 | 0.59 |