Evaluation of the Effects of Colipral on Microbiota Gut Composition in Patients Presenting With Ulcerative Colitis During Remission Phase and Functional Disorders (COLIPRAL)

Evaluation of the Effects of Colipral® (E.Coli 5C LMG S-33222) on Microbiota Gut Composition in Patients Presenting With Ulcerative Colitis During Remission Phase and Functional Disorders

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Inflammatory Bowel Disease, Ulcerative Colitis Type; Functional Disorder of Gastrointestinal Tract
• Intervention / Treatment: Dietary supplement: Food Supplement Colipral in film-coated tablets containing Escherichia coli 5C LMG S-33222; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Padova
    • Padova, Padova, Italy, 35128
      • Azienda Ospedale - Univeristà Padova
      • Contact: Fabiana Zingone; Phone Number: +39 0498215656; Email: fabiana.zingone@unipd.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dietary Supplement Group (Treatment A); In this arm patients receive 2 tablets/day of Colipral (1/breakfast, and 1/dinner, before the meal) for 60 days	Dietary supplement: Food 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
Placebo Comparator: Placebo Group (Treatment B); In this arm patients receive 2 tablets/day of placebo (1/breakfast, and 1/dinner, before the meal) for 60 days	Other: Placebo; 2 tablets/day of Placebo (1/breakfast, and 1/dinner, before the meal) for 60 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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)
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.	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).
Dietary habits	Patients' dietary habits will be analysed using the WCRF questionnaire, which assesses dietary habits, particularly the questions focus on common eating patterns.	T=0 (baseline, before treatment) and T=3 (after taking both treatment A and treatment B)
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.	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	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.	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	Severity of gastrointestinal symptoms will be assessed using Bristol Stool Scale. This is a chart that rate the stools into seven categories based on form and consistency. Types 1,2 (constipation), types 3,4 (normal bowel function), types 5,6,7(diarrhea).	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).

Collaborators and Investigators

• Sponsor: University of Padova

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: July 29, 2026
• First Submitted That Met QC Criteria: August 3, 2026
• First Posted (Actual): August 7, 2026

Study Record Updates

• Last Update Posted (Actual): August 7, 2026
• Last Update Submitted That Met QC Criteria: August 3, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: ulcerative colitis; gut microbiota; inflammatory bowel disease; functional disorders
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Colonic Diseases; Gastroenteritis; Colitis; Gastrointestinal Diseases; Colitis, Ulcerative; Inflammatory Bowel Diseases
• Other Study ID Numbers: 6576/AO/26

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data underlying the results reported in publications will be made available to qualified researchers upon reasonable request to the Principal Investigator, subject to approval of the study Sponsor and to a signed data access agreement.
• IPD Sharing Time Frame: Beginning 6 months after publication of the main results and ending 5 years thereafter.
• IPD Sharing Access Criteria: Requests must include a methodologically sound proposal and will be evaluated by the Principal Investigator and the Sponsor; data will be shared after approval of the proposal and signature of a data access agreement.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No