NCT07591012Recruiting
Sodium Butyrate and Kluyveromyces Marxianus Supplementation in Inflammatory Bowel Disease
Safety and Tolerability of Sodium Butyrate and Kluyveromyces Marxianus Supplementation in Inflammatory Bowel Disease Treatment
Source: ClinicalTrials.gov · Last updated 15 May 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 13 Apr 2026
- Start date
- 1 May 2026
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- University of Padova
- Diseases
- Ulcerative colitis
- NCT number
- NCT07591012
What you commit to
- Study type: Interventional
- Planned participants: 40
- From 1 May 2026 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients under antibiotic and/or probiotic treatment within 10 days prior to Visit 1.
Other illness
- Known diagnosis of CD( Crohn disease), indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis or microscopic colitis
Other
- Patients that have active UC, determined by clinical, endoscopic and histopathological evidence
- Positive stool culture for active C. difficile
- Pregnant women
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Edoardo Savarino Coordinator of this site? Confirm its status | Padova | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.