Sodium Butyrate and Kluyveromyces Marxianus Supplementation in Inflammatory Bowel Disease

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity of Padova

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Butyrate

Treatment groups

40 Participants
are divided into 1 treatment group

Sponsors and collaborators