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Not yet recruiting NCT07751081

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

No phase Interventional Inflammatory Bowel Disease, Ulcerative Colitis Type Functional Disorder of Gastrointestinal Tract

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Food Supplement Colipral in film-coated tablets containing Escherichia coli 5C LMG S-33222, Placebo.
Who it may be relevant to
Registry conditions: Inflammatory Bowel Disease, Ulcerative Colitis Type, Functional Disorder of Gastrointestinal Tract. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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 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
  • Other Placebo
    2 tablets/day of Placebo (1/breakfast, and 1/dinner, before the meal) for 60 days

Primary outcome measures

  • Microbiota gut composition [Time frame: 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 (6)
  • Fecal calprotectin levels [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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).]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Double blind
Primary purpose
Health services research

Study locations

Italy · 1 center
  • Azienda Ospedale - Univeristà Padova — Padova

Identifiers

NCT: NCT07751081 · 6576/AO/26

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗