SOIBD Collagenous Colitis Maintenance Study

Inclusion criteria

• . Signed informed consent,
• . Patients aged \>= 18 years,
• . Histologically established diagnosis of collagenous colitis (CC) defined as:
• . Thickened sub-epithelial collagen layer \>= 10 µm on well-orientated sections,
• . Increased amount of inflammatory cells indicating chronic inflammation in the lamina propria,
• . History of non-bloody, watery diarrhoea for more than 2 weeks prior screening in patients with newly diagnosed collagenous colitis, or history of clinical relapse for more than 1 week prior screening in patients with previously established collagenous colitis,
• . A mean of \>= 3 stools/day, thereof a mean of \>= 1 watery stools/day, during the week prior baseline,
• . Women of child-bearing potential and being heterosexually active have to apply appropriate contraceptive methods, e.g., hormonal contraception, intrauterine device (IUD), double-barrier method of contraception (e.g., use of a condom and spermicide), or partner has undergone vasectomy. The investigator is responsible for determining whether the subject has adequate birth control for study participation.

Exclusion criteria