Sodium Butyrate and Kluyveromyces Marxianus Supplementation in Inflammatory Bowel Disease

NCT07591012 | Recruiting DMC

• 1 other identifier: 6440/AO/25
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Ulcerative Colitis (Disorder)

Keywords

Ulcerative colitis; Butyrate; Kluyveromyces marxianus; Yearst

Outcome Measures

Primary Outcomes (1)

• 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

  8 weeks

Secondary Outcomes (1)

• Safety and tolerability

  8 weeks

Study Arms (1)

Butimixx

OTHER

single arm

Dietary Supplement: Butyrate

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.

Butimixx

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Padova: lead

Study Sites (1)

Edoardo Savarino

Padova, 352121, Italy

RECRUITING

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Butyrates

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids

Study Officials

• Edoardo V Savarino

  Università degli Studi di Padova, DiSCOG

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Edoardo V Savarino

CONTACT

00390498127749; edoardo.savarinoi@unipd.it

Sonia Facchin

CONTACT

sonia.facchin@unipd.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: April 13, 2026
• First Posted: May 15, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 30, 2027
• Last Updated: May 15, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)