Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT06642883

Evaluation of ProLife 10 FORTE on Gut Microbiota Composition in UC Patients

Led by University of Padova · Updated on 2024-10-15

70

Participants Needed

1

Research Sites

108 weeks

Total Duration

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AI-Summary

What this Trial Is About

This clinical trial aims to learn if the probiotic Prolife 10 Forte could improve the Gut Microbiota composition of Ulcerative colitis patients during the remission phase. The main questions it seeks to answer are: * Does Prolife 10 Forte improve the microbiota composition in patients with Ulcerative colitis? * Is it possible to highlight the variation in microbial pathways? * What clinical parameters vary and are associated with changes in the gut microbiota? Researchers will compare Prolife 10 Forte to a placebo (a look-alike substance containing no drug) to see if the probiotics improve microbiota. Participants will: * Take 1 vial/day of Prolife 10 Forte /Placebo for 60 days. * Visit the clinic two times for checkups, Questionaire and tests

CONDITIONS

Official Title

Evaluation of ProLife 10 FORTE on Gut Microbiota Composition in UC Patients

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of Ulcerative Colitis confirmed by clinical, endoscopic, and histopathological evidence with disease in remission phase
  • Age between 18 and 75 years old
  • Ability to participate fully in all aspects of this clinical trial
Not Eligible

You will not qualify if you...

  • Active Ulcerative Colitis confirmed by clinical, endoscopic, and histopathological evidence
  • Diagnosis of Crohn's Disease, indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis, or microscopic colitis
  • Positive stool culture for active Clostridium difficile
  • Pregnant women
  • Allergy to soy or fructose
  • Use of antibiotics or probiotics within 10 days before the first visit

AI-Screening

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Trial Site Locations

Total: 1 location

1

Edoardo Vincenzo Savarino

Padua, Padua, Italy, 35128

Actively Recruiting

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Research Team

E

Edoardo V. Savarino, Prof.MD; PhD

CONTACT

S

Sonia Facchin, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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