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
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.
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
Single group
Butyrate
Dietary supplementPatients will be treated with the ButyMixx , a stick pack probiotic supplement composed sodium butyrate and the yeast Kluyveromyces marxianus, as primary compounds (300 mg and 33.5 mg rispectively).Patients will be asked to take 2 stick packs per day, before meals for 8 weeks.
Assessment of the clinical effectiveness of ButyMixx
The primary outcome is defined as the assessment of the clinical effectiveness of ButyMixx through a pre-post improvement (T0 vs T1) in at least one of the following three parameters: Partial Mayo Score (pMayo) - a clinical index measuring ulcerative colitis activity, including stool frequency, rectal bleeding, and physician's global assessment. IBDQ (Inflammatory Bowel Disease Questionnaire) - a validated questionnaire assessing disease-related quality of life. Fecal calprotectin (fCal) - an objective biomarker of intestinal inflammation. The primary outcome is therefore considered achieved if, after 8 weeks of supplementation, a clinically and statistically significant improvement is observed in at least one of these three indicators
Safety and tolerability
The secondary outcome is represented by the assessment of the safety and tolerability of the ButyMixx supplement. Systematic recording of adverse events (AEs) and serious adverse events (SAEs) All clinical events occurring during the study period are recorded according to standardized regulatory definitions and criteria. This allows assessment of whether ButyMixx intake is associated with undesirable effects and enables estimation of their frequency, type, and severity. Exploratory analysis of the intestinal microbiota Modulation of the microbiota profile is evaluated through 16S rRNA gene sequencing, and ITS(Internal Transcribed Spacer) sequencing for bacteria and fungi, with particular attention to the presence and dynamics of yeast species. This component is not intended as an efficacy endpoint, but rather as a tool to confirm that supplementation does not induce potentially unfavorable microbiological alterations, thereby strength
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