Functional Disorder of Gastrointestinal Tract, Inflammatory Bowel Disease, Ulcerative Colitis Type
Conditions
Keywords
inflammatory bowel disease, ulcerative colitis, functional disorders, gut microbiota
Brief summary
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.
Detailed description
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 at three time points: T=0 (baseline, before treatment), T=1 (after 60 days of treatment A or B), and T=3 (after an additional 60 days of treatment A or B). The secondary endpoint will be the assessment of the clinical parameters variation based on fecal calprotectin in patients presenting UC during remission phase and DGBI at three time points: T=0 (baseline, before treatment), T=1 (after an additional 60 days of treatment A or B), and T=3 (after 60 days of treatment A or B). The severity of gastrointestinal symptoms and quality of life will be assessed using the IBDQ, IBS SSS, VAS, and Bristol Stool Scale questionnaires at three time points: T=0 (baseline, before treatment), T=1 (after 60 days of treatment A or B), and T=3 (after an additional 60 days of treatment A or B). Patients' dietary habits will be analysed using the WCRF questionnaire at the first and final visit.
Interventions
DIETARY_SUPPLEMENTFood Supplement Colipral in film-coated tablets containing Escherichia coli 5C LMG S-33222
2 tablets/day of Colipral (1/breakfast, and 1/dinner, before the meal) for 60 days
OTHERPlacebo
2 tablets/day of Placebo (1/breakfast, and 1/dinner, before the meal) for 60 days
Sponsors
University of Padova
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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 * Age in the range 18-70 years * Subjects capable of conforming to the study protocol * Subjects who have given their free and informed consent
Exclusion criteria
* 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 * Subjects who become unable to conform to protocol * Recent history or suspicion of alcohol abuse or drug addiction * Indication for the initiation of a new drug therapy during the study * History of current or recent antibiotic or probiotics use within the last 30 days * Subjects who are treated with antibiotics
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Microbiota gut composition | T=0 (baseline, before treatment), T=1 (after 60 days of treatment A or B), and T=3 (after an additional 60 days of treatment A or B). | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fecal calprotectin levels | T=0 (baseline, before treatment), T=1 (after an additional 60 days of treatment A or B), and T=3 (after 60 days of treatment A or B) | 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 | T=0 (baseline, before treatment), T=1 (after 60 days of treatment A or B), and T=3 (after an additional 60 days of treatment A or B). | 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 | T=0 (baseline, before treatment) and T=3 (after taking both treatment A and treatment B) | 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 | T=0 (baseline, before treatment), T=1 (after 60 days of treatment A or B), and T=3 (after an additional 60 days of treatment A or B). | 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. |
| Severity of gastrointestinal symptoms | T=0 (baseline, before treatment), T=1 (after 60 days of treatment A or B), and T=3 (after an additional 60 days of treatment A or B). | Severity of gastrointestinal symptoms will be assessed using the Visual Analog Scale (VAS) that measure for acute and chronic pain by making a handwritten mark on a 10-cm line (0 = "No Pain" to 100 = "Worst Imaginable Pain"). The patient marks a point on the line corresponding to their symptom intensity. |
Countries
Italy
Outcome results
None listed