ButyMixx for Ulcerative Colitis in Remission

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study evaluates the safety and potential benefits of ButyMixx in adults with ulcerative colitis who are in clinical remission. Participants will take two sachets daily for eight weeks and provide stool samples before and after treatment. Outcomes include symptom improvement, quality of life, intestinal inflammation, and changes in gut microbiota balance. The study also aims to monitor for any adverse effects in this population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Where it's running

• Edoardo Savarino
  Padova, Italy Recruiting

Study contacts

• Principal investigator: Edoardo V Savarino — Università degli Studi di Padova, DiSCOG
• Study coordinator: Edoardo V Savarino
• Email: edoardo.savarinoi@unipd.it
• Phone: 00390498127749

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.