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
Crossover
Food Supplement Colipral in film-coated tablets containing Escherichia coli 5C LMG S-33222
Dietary supplement2 tablets/day of Colipral (1/breakfast, and 1/dinner, before the meal) for 60 days
Placebo
Other intervention2 tablets/day of Placebo (1/breakfast, and 1/dinner, before the meal) for 60 days
Microbiota gut composition
The primary endpoint will be the variation in gut microbiota analyzed through 16S rRNA gene sequencing from a fecal sample of patients presenting UC during remission phase and DGBI.
Fecal calprotectin levels
Concentration of fecal calprotectin measured in mg/Kg as an objective marker of intestinal inflammation. Normal value is \<250 mg/Kg, with higher values indicating active intestinal inflammation.
Quality of life in patiets with inflammatory bowel disease
Quality of life will be assessed using the IBDQ (Inflammatory Bowel Disease Questionnaire). This is a 32-item questionnaire that evaluates symptoms and well-being over the prior two weeks using a 7-point scale from 1 (worst) to 7 (best). Total scores range from 32 to 224, with higher scores indicating a better quality of life.
Dietary habits
Patients' dietary habits will be analysed using the WCRF questionnaire, which assesses dietary habits, particularly the questions focus on common eating patterns.
Gastrointestinal symptom severity in patients with Irritable Bowel Syndrome
The severity of gastrointestinal symptoms will be assessed using IBS Symptom Severity Scale, which measures the intensity and frequency of abdominal pain, severity of abdominal distention, and dissatisfaction with bowel habits. Scores on the IBS-SSS range from 0 to 500 with higher scores indicating more severe symptoms.
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