Sodium Butyrate and Kluyveromyces Marxianus Supplementation in Inflammatory Bowel Disease
Recruiting · NCT07591012 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Padova
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
The goal of this clinical trial is to learn if a dietary supplement called ButyMixx can help people with ulcerative colitis in remission feel better and keep their intestines less inflamed. ButyMixx contains: * Sodium butyrate, a substance normally produced by our gut microbiota that helps protect the intestinal lining and reduce inflammation. * A "beneficial" yeast (Kluyveromyces marxianus), similar to probiotics, which may support the balance of the intestinal microbiota. It will also learn about the safety of dietary supplement. The main questions it aims to answer are: * Does ButyMixx after 2 months of supplementation * Symptoms improve, * Quality of life improves, * Intestinal inflammation decreases , * The gut microbiota becomes more "balanced" * What medical problems do participants have when taking ButyMixx ? Participants will: * Take 2 sachets of ButyMixx per day for 8 weeks * Before starting and at the end of the 8 weeks: * Provide a stool sample * Complete a quality-of-life questionnaire * Be assessed by a doctor using a symptom score
Who can take part
Inclusion criteria
- Diagnosis of UC confirmed by clinical, endoscopic and histopathological evidence. Disease in remission phase confirmed by clinical, endoscopic and histopathological evidence.
- Age between 18 and 75 years old
- Ability of subject to participate fully in all aspects of this clinical trial.
Exclusion criteria
- Patients that have active UC, determined by clinical, endoscopic and histopathological evidence
- Known diagnosis of CD( Crohn disease), indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis or microscopic colitis
- Positive stool culture for active C. difficile
- Pregnant women
- Patients under antibiotic and/or probiotic treatment within 10 days prior to Visit 1.
Where it is running
1 location listed.
- Edoardo Savarino - Padova, Italy