Ulcerative Colitis (Disorder)ButymixxNCT07591012
Sodium Butyrate and Kluyveromyces Marxianus Supplementation in Inflammatory Bowel Disease
A study testing Butyrate in people with Ulcerative Colitis (Disorder), run by University of Padova at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ulcerative Colitis (Disorder)
- What is being tested?
- Butyrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 1 May 2026to 30 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sonia Facchin contact
Italy1 site, 1 recruiting
- Recruiting
Edoardo Savarino
Padova, 352121
Edoardo Savarino
About this study
Official title: Safety and Tolerability of Sodium Butyrate and Kluyveromyces Marxianus Supplementation in Inflammatory Bowel Disease Treatment
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:
Read more
- 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
Read the detailed description
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:
- digestion and nutrient metabolism
- protection against pathogenic microorganisms
- regulation of immune responses
- maintenance of intestinal barrier integrity In patients with UC, this microbial ecosystem is frequently altered (a condition known as dysbiosis), even during remission. Restoring a balanced microbiota is therefore considered a key therapeutic target.
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:
- it is the main energy source for colonocytes
- supports epithelial repair and regeneration
- exerts anti-inflammatory effects
- contributes to the maintenance of intestinal barrier integrity In patients with UC, endogenous butyrate production is often reduced.
- Kluyveromyces marxianus
This is a probiotic yeast, commonly found in kefir, whose probiotic potential has been investigated in preclinical models. Studies have shown that K. marxianus:
- survives gastrointestinal transit efficiently
- interacts with the host immune system
- reduces pro-inflammatory signaling
- supports a more balanced intestinal microbiota It is recognized as safe by both European and US regulatory authorities.
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:
- maintaining lower levels of intestinal inflammation
- improving patients' quality of life
- supporting gut microbiota homeostasis
- potentially reducing the risk of disease relapse
Study population
A total of 40 patients will be enrolled, meeting the following criteria:
- age between 18 and 75 years
- diagnosis of ulcerative colitis in clinical remission
- stable background medical therapy Patients with active disease, other forms of colitis, ongoing intestinal infections, pregnancy, or recent use of antibiotics/probiotics will be excluded.
Study design and procedures Study duration
- 8 weeks Supplement administration
- Two sachets of ButyMixx daily, taken before meals Study visits
Two visits are scheduled:
Baseline visit (T0)
- Clinical symptom assessment
- Quality-of-life questionnaire administration
- Stool sample collection for:
- fecal calprotectin (marker of intestinal inflammation)
- gut microbiota analysis End-of-treatment visit (T1, after 8 weeks)
- Reassessment of symptoms and quality of life
- Repeat stool sample collection
- Recording of any adverse events
Study outcomes
The study aims to determine whether, after two months of supplementation:
- clinical symptoms improve
- quality of life increases
- intestinal inflammation decreases
- the gut microbiota shows a more balanced profile In parallel, the safety and tolerability of the supplement will be carefully evaluated.
Why is this study important?
If proven effective and safe, ButyMixx could become:
- a natural adjunct to pharmacological therapy
- a tool to support long-term intestinal health
- a strategy to reduce disease burden and improve daily well-being in patients with ulcerative colitis Contributing to a more comprehensive and preventive approach to disease management
- Conditions
- Ulcerative Colitis (Disorder)
- Being tested
- Butyrate
- Keywords
- Ulcerative colitis, Butyrate, Kluyveromyces marxianus, Yearst
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ButyrateDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Butimixx | Other | single arm Receives: Dietary Supplement: Butyrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 8 weeks
Secondary outcomes (1)
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
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start1 May 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative Colitis (Disorder)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The study is an exploratory, single-arm pilot clinical trial designed to evaluate the effectiveness, safety and tolerability of the dietary supplement ButyMixx, containing sodium butyrate and the probiotic yeast Kluyveromyces marxianus, in patients with ulcerative colitis in clinical remission. Forty adult patients (18-75 years) on stable standard therapy will be enrolled. All participants will receive two sachets of ButyMixx daily for 8 weeks, in addition to their usual treatment. A pre-post design is adopted, with evaluations performed at baseline (T0) and at the end of treatment (T1). Effectiveness will be assessed through changes in the partial Mayo Score, Inflammatory Bowel Disease Questionnaire (IBDQ) scores and fecal calprotectin levels. Safety and tolerability will be monitored by recording adverse events and by exploratory analysis of gut microbiota composition using next-generation sequencing.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Savarino Edoardo Vincenzo, University of Padova
- Investigators
- Edoardo V Savarino, Principal investigator, Università degli Studi di Padova, DiSCOG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07591012
- Sponsor's protocol ID
- 6440/AO/25
- Acronym
- Butymixx
- Status last verified
- May 2026
- First submitted
- 13 Apr 2026
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Tolerability of Sodium Butyrate and Kluyveromyces Marxianus Supplementation in Inflammatory Bowel Disease Treatment
- ClinicalTrials.gov ID
- NCT07591012
- Acronym / sponsor ID
- Butymixx / 6440/AO/25
- Conditions
- Ulcerative Colitis (Disorder)
- Keywords
- Ulcerative colitis, Butyrate, Kluyveromyces marxianus, Yearst
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 15 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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:
- digestion and nutrient metabolism
- protection against pathogenic microorganisms
- regulation of immune responses
- maintenance of intestinal barrier integrity In patients with UC, this microbial ecosystem is frequently altered (a condition known as dysbiosis), even during remission. Restoring a balanced microbiota is therefore considered a key therapeutic target.
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:
- it is the main energy source for colonocytes
- supports epithelial repair and regeneration
- exerts anti-inflammatory effects
- contributes to the maintenance of intestinal barrier integrity In patients with UC, endogenous butyrate production is often reduced.
- Kluyveromyces marxianus
This is a probiotic yeast, commonly found in kefir, whose probiotic potential has been investigated in preclinical models. Studies have shown that K. marxianus:
- survives gastrointestinal transit efficiently
- interacts with the host immune system
- reduces pro-inflammatory signaling
- supports a more balanced intestinal microbiota It is recognized as safe by both European and US regulatory authorities.
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:
- maintaining lower levels of intestinal inflammation
- improving patients' quality of life
- supporting gut microbiota homeostasis
- potentially reducing the risk of disease relapse
Study population
A total of 40 patients will be enrolled, meeting the following criteria:
- age between 18 and 75 years
- diagnosis of ulcerative colitis in clinical remission
- stable background medical therapy Patients with active disease, other forms of colitis, ongoing intestinal infections, pregnancy, or recent use of antibiotics/probiotics will be excluded.
Study design and procedures Study duration
- 8 weeks Supplement administration
- Two sachets of ButyMixx daily, taken before meals Study visits
Two visits are scheduled:
Baseline visit (T0)
- Clinical symptom assessment
- Quality-of-life questionnaire administration
- Stool sample collection for:
- fecal calprotectin (marker of intestinal inflammation)
- gut microbiota analysis End-of-treatment visit (T1, after 8 weeks)
- Reassessment of symptoms and quality of life
- Repeat stool sample collection
- Recording of any adverse events
Study outcomes
The study aims to determine whether, after two months of supplementation:
- clinical symptoms improve
- quality of life increases
- intestinal inflammation decreases
- the gut microbiota shows a more balanced profile In parallel, the safety and tolerability of the supplement will be carefully evaluated.
Why is this study important?
If proven effective and safe, ButyMixx could become:
- a natural adjunct to pharmacological therapy
- a tool to support long-term intestinal health
- a strategy to reduce disease burden and improve daily well-being in patients with ulcerative colitis Contributing to a more comprehensive and preventive approach to disease management
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study is an exploratory, single-arm pilot clinical trial designed to evaluate the effectiveness, safety and tolerability of the dietary supplement ButyMixx, containing sodium butyrate and the probiotic yeast Kluyveromyces marxianus, in patients with ulcerative colitis in clinical remission. Forty adult patients (18-75 years) on stable standard therapy will be enrolled. All participants will receive two sachets of ButyMixx daily for 8 weeks, in addition to their usual treatment. A pre-post design is adopted, with evaluations performed at baseline (T0) and at the end of treatment (T1). Effectiveness will be assessed through changes in the partial Mayo Score, Inflammatory Bowel Disease Questionnaire (IBDQ) scores and fecal calprotectin levels. Safety and tolerability will be monitored by recording adverse events and by exploratory analysis of gut microbiota composition using next-generation sequencing.
| Arm | Type | Receives |
|---|---|---|
| Butimixx | Other | Dietary Supplement: Butyratesingle arm |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ButyratePatients 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. | Dietary supplement | Butimixx |
Primary outcome
Assessment of the clinical effectiveness of ButyMixx
Time frame: 8 weeks
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
1 secondary outcome
Safety and tolerability
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sonia Facchin contact
Edoardo V Savarino principal investigator
Università degli Studi di Padova, DiSCOG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Butyrate in people with Ulcerative Colitis (Disorder), run by University of Padova at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Edoardo V Savarino (00390498127749, edoardo.savarinoi@unipd.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the clinical effectiveness of ButyMixx (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.