Butyrate: Patients 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.
Study summary
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
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Assessment of the clinical effectiveness of ButyMixx — 8 weeks 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
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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