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Sodium Butyrate and Kluyveromyces Marxianus Supplementation in Inflammatory Bowel Disease

NCT07591012 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-05-15

No results posted yet for this study

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)

Interventions

DIETARY_SUPPLEMENT

Butyrate

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.

Sponsors & Collaborators

  • University of Padova

    lead OTHER

Principal Investigators

  • Edoardo V Savarino · Università degli Studi di Padova, DiSCOG

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2026-12-31
Completion
2027-03-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07591012 on ClinicalTrials.gov