Ulcerative Colitis Clinical Trials

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Safety and Tolerability of Sodium Butyrate and Kluyveromyces Marxianus Supplementation in Inflammatory Bowel Disease Treatment

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Italy
Edoardo Savarino
RECRUITING
Padova
Contact Information
Primary
Edoardo V Savarino
edoardo.savarinoi@unipd.it
00390498127749
Backup
Sonia Facchin
sonia.facchin@unipd.it
Time Frame
Start Date: 2026-05-01
Estimated Completion Date: 2027-03-30
Participants
Target number of participants: 40
Treatments
Other: Butimixx
single arm
Sponsors
Leads: University of Padova

This content was sourced from clinicaltrials.gov