Table 2.
Most common adverse events.
| Test 1 (N = 25) | Control 1 (N = 23) | RR (95% CI) | Test 3 (N = 24) | Control 3 (N = 24) | RR (95% CI) | |
|---|---|---|---|---|---|---|
| Product consumption | ||||||
| AE [n (%)] | 13 (52%) | 12 (52%) | 1.00 (0.58–1.72) | 12 (50%) | 16 (67%) | 0.75 (0.46–1.22) |
| Serious AE [n (%)] | 0 | 0 | NA | 0 | 1 (4%) | NA |
| AE of severe intensity [n (%)] | 1 (4%) | 0 | NA | 0 | 0 | NA |
| AE related to the study product [n (%)]a | 11 (44%) | 12 (52%) | 0.84 (0.47–1.52) | 10 (42%) | 13 (54%) | 0.77 (0.42–1.40) |
| Gastrointestinal AE [n (%)] | 11 (44%) | 10 (43%) | 1.01 (0.53–1.92) | 10 (42%) | 15 (63%) | 0.67 (0.38–1.17) |
| Flatulence | 10 (40%) | 9 (39%) | 1.02 (0.51–2.06) | 9 (38%) | 14 (58%) | 0.64 (0.35–1.19) |
| Abnormal borborygmi | 4 (16%) | 4 (17%) | 0.92 (0.26–3.26) | 6 (25%) | 7 (29%) | 0.86 (0.34–2.18) |
| Abdominal pain | 2 (8%) | 4 (17%) | 0.46 (0.09–2.28) | 2 (8%) | 1 (4%) | 2.00 (0.19–20.61) |
| Painb | 0 | 0 | NA | 2 (8%) | 0 | NA |
| Nasopharyngitis | 2 (8%) | 1 (4%) | 1.84 (0.18–18.96) | 1 (4%) | 1 (4%) | 1.00 (0.07–15.08) |
| Fecal calprotectin concentrationc | 0 | 3 (13%) | NA | 0 | 0 | NA |
| Headache | 0 | 0 | NA | 1 (4%) | 3 (13%) | 0.33 (0.04–2.98) |
| Follow-up | ||||||
| AE [n (%)] | 14 (56%) | 8 (35%) | 1.61 (0.83–3.11) | 7 (29%) | 10 (42%) | 0.70 (0.32–1.53) |
| Serious AE [n (%)] | 0 | 0 | NA | 0 | 0 | NA |
| AE of severe intensity [n (%)] | 1 (4.0%) | 0 | NA | 0 | 0 | NA |
| AE related to the study product [n (%)]a | 2 (8%) | 3 (13%) | 0.61 (0.11–3.35) | 2 (8%) | 2 (8%) | 1.00 (0.15–6.53) |
| Gastrointestinal AE [n (%)] | 12 (48%) | 7 (30%) | 1.58 (0.75–3.31) | 6 (25%) | 9 (38%) | 0.67 (0.09–1.94) |
| Flatulence | 9 (36%) | 7 (30%) | 1.18 (0.53–2.66) | 5 (21%) | 8 (33%) | 0.63 (0.24–1.64) |
| Abnormal borborygmi | 5 (20%) | 3 (13%) | 1.53 (0.41–5.71) | 1 (4%) | 1 (4%) | 1.00 (0.07–15.08) |
| Abdominal pain | 4 (16%) | 2 (9%) | 1.84 (0.37–9.12) | 1 (4%) | 2 (8%) | 0.50 (0.05–5.15) |
| Diarrhea | 0 | 1 (4%) | NA | 2 (8%) | 0 | NA |
| Fecal calprotectin concentrationc | 3 (12%) | 1 (4%) | 2.76 (0.31–24.7) | 0 | 3 (13%) | NA |
In number (n) and percentage of subjects with at least one AE. Occurrence of AE by type is detailed for AE observed in at least in 2 subjects in one group.
aPossibly, probably or highly probably.
bRelated to general disorders and administration site conditions.
cSubjects with AE relating to an increase of calprotectin concentration from < 50 μg/g or from 50 to 100 μg/g at baseline, corresponding to excluded and possible inflammatory gastric disease respectively, to a concentration > 100 μg/g during the study, corresponding to a confirmed inflammation.