Eligible patients were enrolled and randomised to treatment with either 40, 20, or 10 ml EcN (24, 23, and 23 patients, respectively) or placebo (20 patients; Figure 1).
Of all PP patients with abnormal mucosal findings at baseline (N = 57), 8/17 (47.6%, 40 ml EcN), 7/18 (38.9%, 20 ml EcN), 5/11 (45.5%, 10 ml EcN), and 3/11 (27.3%, placebo) showed remission or improvement of the histological score.
In the present trial we investigated the treatment of patients suffering from active UC proctitis/proctosigmoiditis, with 40, 20, or 10 ml EcN enemas (108 EcN/ml) for 4 to 8 weeks and compared it to placebo.
This assumes a difference between EcN and placebo and differences amongst the 3 EcN groups with increasing efficacy achieved by larger volumes of EcN.
The book containing the full guidelines and other EU documents on cancer screening can be downloaded free from the internet: http://ec.europa.eu/health/ph_determinants/genetics/keydo_genetics_en.htm EU: ECCSN (SPC.2002475), ECN (2004309), and ECCG-ECN (2006322).
Among many other strain-specific characteristics [ 2, 5, 6], EcN exerts an intense immunomodulatory effect in children [ 3, 11].
There was also a remarkable difference in the response rates, as determined on days 14 (EcN: 93.3%; placebo: 65.8%) and 21 (EcN: 98.7%; placebo: 71.1%), thus showing a statistically significant superiority of EcN on both days (p = 0.0017 and p < 0.001, respectively).
The same trend was observed for the disappearance of abdominal pain (28/30 EcN patients vs. 24/33 placebo patients) and abdominal cramps (17/18 EcN patients vs. 21/26 placebo patients) (Table 3).
Accordingly, the PP analysis set comprised 57 patients (17/23, 18/23, and 11/22 EcN 40, 20, and 10 ml patients, respectively, and 11/20 placebo-treated patients).
Premature discontinuation of the study for lack of efficacy occurred in 35/88 patients (7/23, 8/23, and 10/22 in the 40, 20, and 10 ml EcN groups, respectively, and 10/20 in the placebo group).
