The study is a double-blind, placebo-controlled, crossover, randomised trial, in which enrolled subjects will be included for 18 months. This study aims to evaluate the effect of the Colipral as a Food Supplement prescribed according to the standard of care of patients suffering UC during remission phase and DGBI.
The primary objective of the study is to evaluate the variation in gut microbiota, specifically focusing on bacterial diversity and abundance, in patients with UC during the remission phase and DGBI.
The secondary objective of the study is to evaluate the clinical parameters variations (based on fecal calprotectin and IBDQ's score before and after the treatment), the severity of gastrointestinal symptoms, the quality of life, and the maintenance of the remission phase in patients with UC in remission and DGBI.
Diagnosis of UC confirmed by clinical, endoscopic and histopathological evidence.
Disease in remission phase confirmed by clinical, endoscopic and histopathological evidence for at least 6 months
Diagnosis of disorders of gut-brain interaction (DGBI): IBS-D, IBS-M, bloating, and abdominal pain
Male/female
History of gastrointestinal disorders or gastrointestinal surgery interfering with gastrointestinal function
Subjects with untreated food intolerance, i.e. remaining symptomatic despite the withdrawal of the suspected food
Currently following a restrictive diet (for example low FODMAPs diet or vegan diet)
Females of childbearing potential, in the absence of effective contraceptive methods