NCT07591012 Sodium Butyrate and Kluyveromyces Marxianus Supplementation in Inflammatory Bowel Disease
| NCT ID | NCT07591012 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Padova |
| Condition | Ulcerative Colitis (Disorder) |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2026-05-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2026-05-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Edoardo V Savarino
PRINCIPAL INVESTIGATOR
Università degli Studi di Padova, DiSCOG
Frequently Asked Questions
Who can join the NCT07591012 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Ulcerative Colitis (Disorder). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07591012 currently recruiting?
Yes, NCT07591012 is actively recruiting participants. Contact the research team at edoardo.savarinoi@unipd.it for enrollment information.
Where is the NCT07591012 trial being conducted?
This trial is being conducted at Padova, Italy.
Who is sponsoring the NCT07591012 clinical trial?
NCT07591012 is sponsored by University of Padova. The principal investigator is Edoardo V Savarino at Università degli Studi di Padova, DiSCOG. The trial plans to enroll 40 participants.
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