Colipral supplement and gut bacteria in ulcerative colitis in remission with digestive symptoms
Tests Colipral on gut bacteria in adults with ulcerative colitis in remission.
Plain-language title generated from the registry record
Registry title: Evaluation of the Effects of Colipral on Microbiota Gut Composition in Patients Presenting With Ulcerative Colitis During Remission Phase and Functional Disorders
Key facts
- Where
- Padova, ItalySee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT07751081, who can take part
Where in Italy
- Azienda Ospedale - Univeristà PadovaPadova, ItalyNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Padova
- Trial code
- NCT07751081
- Record updated
- 7 August 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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: Recent history or suspicion of alcohol abuse or drug addiction; Indication for the initiation of a new drug therapy during the study; Subjects who are treated with antibiotics; History of gastrointestinal disorders or gastrointestinal surgery interfering with gastrointestinal function; History of current or recent antibiotic or probiotics use within the last 30 days; 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.