Sodium Butyrate and Kluyveromyces Marxianus Supplementation in Inflammatory Bowel Disease
Not applicable · Testing Butyrate · 1 site · University of Padova
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Butyrate (a dietary supplement) as a possible treatment. Condition(s) listed: Ulcerative Colitis (Disorder).
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 to 75
- Any sex
Some of the main requirements, copied from the record:
- 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.
There are also 5 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 40 participants are expected to take part.
- Start date: 2026-05-01 (planned).
- Main results expected around 2026-12-31 (estimate from the record).
- 1 study site listed (1 marked recruiting) in Italy.
Main thing being measured
- Assessment of the clinical effectiveness of ButyMixx (8 weeks)
In the researchers’ words
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,…
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Ulcerative Colitis (Disorder) |
| Lead sponsor | University of Padova |
| Enrollment | 40 (estimated) |
| Start date | 2026-05-01 |
| Primary completion (est.) | 2026-12-31 |
| First posted | 2026-05-15 |
| Last updated | 2026-05-15 |
| Official title | Safety and Tolerability of Sodium Butyrate and Kluyveromyces Marxianus Supplementation in Inflammatory Bowel Disease Treatment |
| ClinicalTrials.gov ID | NCT07591012 |
Interventions
- Butyrate (Dietary Supplement)
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.
Full eligibility criteria (from the record)
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.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Edoardo Savarino | Padova | Italy | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.