An interventional study of Butyrate in Ulcerative Colitis (Disorder), sponsored by University of Padova. Recruiting at 1 site in Italy. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-05-15.
Sponsored by University of Padova · Not applicable, Interventional, and Treatment
Among 209 studies in Colitis, Ulcerative with a site in Italy — 48 open to participants now, 77 under way, 27 of them phase 3. Colitis, Ulcerative · Italy.
Among the 209 studies in Colitis, Ulcerative with a site in Italy, this one is the 152nd largest by planned enrollment of the 175 interventional ones that give a count, is one of 17 that started in 2026, is one of 24 with no phase, reaches primary completion later than 30 of the 76 other live ones, and was the 197th registered.
1,853 studies on the registry are indexed under Colitis, Ulcerative; 472 are open to participants now.
Browse Colitis, Ulcerative studies →48 of the 209 studies in Colitis, Ulcerative with a site in Italy are open now. Recruiting first, the newest first:
Palisade Bio · Sites in Italy, United States, Canada and 9 more countries
Pfizer · Sites in Italy, United States, Australia and 7 more countries
Janssen Research & Development, LLC · Sites in Italy, United States, Argentina and 30 more countries
Eli Lilly and Company · Sites in Italy, United States, Belgium and 7 more countries
Catholic University of the Sacred Heart · Sites in Italy
A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →
Of the 305 Colitis, Ulcerative studies recruiting now, 134 (44%) set no upper age limit and 134 (44%) stop at 75 or younger; 71 take children under 18; 40 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
209 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 77 · Phase 3 73 · Phase 4 9
First in 2003; this study’s year is marked. 17 started in 2026.
This study's planned enrollment of 40 is below the median of 70 across 1,236 interventional studies indexed under Colitis, Ulcerative.
Median enrollment 182 across the 175 interventional studies, 279 across the 34 observational. Of the 122 that completed or were terminated, 74 (61%) have results posted.
This tab as a report to print or save as PDF → With an account.
153 of 209 have an industry lead sponsor. The 10 most frequent:
University of Padova is the lead sponsor of 215 studies on the registry; 42 are open to participants now.
University of Padova has 6 studies filed under Colitis, Ulcerative — fewer than ten, so there is no comparison to draw.
23 of the studies in Colitis, Ulcerative with a site in Italy that are under way reach primary completion within a year, 6 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06589986Phase 3Hoffmann-La RocheA Study to Assess the Efficacy and Safety of Afimkibart (Also Known as RO7790121) for Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis | 2027-01-30 |
| NCT06260163Phase 3Janssen Research & Development, LLCA Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis | 2027-02-10 |
| NCT04624230Phase 3PfizerEvaluation of Oral Tofacitinib in Children Aged 2 to 17 Years Old Suffering From Moderate to Severe Ulcerative Colitis | 2027-03-17 |
| NCT03006068Phase 3AbbVieA Study to Evaluate the Long-Term Safety and Efficacy of Upadacitinib (ABT-494) in Participants With Ulcerative Colitis (UC) | 2027-07 |
| NCT06880744Phase 3AbbVieA Study to Assess the Change in Disease Activity in Adult Participants With Moderate to Severe Ulcerative Colitis Treated With Risankizumab Compared to Vedolizumab | 2027-08 |
Among the 209 studies in Colitis, Ulcerative with a site in Italy, from their registry updates:
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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:
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
Participants will:
Before starting and at the end of the 8 weeks:
ButyMixx Study A novel natural supportive strategy for Ulcerative Colitis in remission What is ulcerative colitis? Ulcerative colitis (UC) is a chronic inflammatory bowel disease characterized by recurrent inflammation of the colonic mucosa, leading to symptoms such as diarrhea, rectal bleeding, abdominal pain, and fatigue.
Even during clinical remission, when symptoms are minimal or absent, the intestinal mucosa often remains fragile and susceptible to new inflammatory flares.
For this reason, current research is increasingly focused not only on treating acute disease activity, but also on identifying strategies able to maintain mucosal health over time, improve quality of life, and reduce the risk of relapse.
The role of the gut microbiota
The human gut hosts a complex community of microorganisms, known as the gut microbiota, which plays a crucial role in:
What is ButyMixx?
ButyMixx is a dietary supplement combining two natural components:
Sodium butyrate
Butyrate is a short-chain fatty acid normally produced by bacterial fermentation of dietary fibers. It has several well-documented physiological functions:
This is a probiotic yeast, commonly found in kefir, whose probiotic potential has been investigated in preclinical models. Studies have shown that K. marxianus:
Rationale of the study
The study was designed to investigate whether the combination of butyrate and probiotic yeast may represent a natural adjunctive strategy to standard pharmacological therapy (e.g., mesalamine and/or biologics), with the aim of:
Study population
A total of 40 patients will be enrolled, meeting the following criteria:
Study design and procedures Study duration
Two visits are scheduled:
Baseline visit (T0)
Stool sample collection for:
Study outcomes
The study aims to determine whether, after two months of supplementation:
Why is this study important?
If proven effective and safe, ButyMixx could become:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
single arm
Dietary Supplement: Butyrate
Drug pages: Butyrates · Butyric Acid
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.
Assessment of the clinical effectiveness of ButyMixx
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
Time frame: 8 weeks
Safety and tolerability
The secondary outcome is represented by the assessment of the safety and tolerability of the ButyMixx supplement. Systematic recording of adverse events (AEs) and serious adverse events (SAEs) All clinical events occurring during the study period are recorded according to standardized regulatory definitions and criteria. This allows assessment of whether ButyMixx intake is associated with undesirable effects and enables estimation of their frequency, type, and severity. Exploratory analysis of the intestinal microbiota Modulation of the microbiota profile is evaluated through 16S rRNA gene sequencing, and ITS(Internal Transcribed Spacer) sequencing for bacteria and fungi, with particular attention to the presence and dynamics of yeast species. This component is not intended as an efficacy endpoint, but rather as a tool to confirm that supplementation does not induce potentially unfavorable microbiological alterations, thereby strength
Time frame: 8 weeks
Plan to share: No — Individual participant data (IPD) will not be shared.
No publications or documents are linked to this record.
Start is estimated for May 2026; primary completion for Dec 2026, 7 months later.
Of 225 non-industry interventional studies with no phase under Colitis, Ulcerative, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 56. This study's planned 7 months is below that.
Counting every sponsor, half of 236 studies reached it within 34 months; a quarter within 16 and three quarters within 54.
How these figures are worked out, and which studies are left out of them.
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Studies of the drugs tested here: Butyrates · Butyric Acid