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

NCT06642883 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2024-10-15

No results posted yet for this study

Summary

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

  • Ulcerative Colitis in Remission

Interventions

DIETARY_SUPPLEMENT

Prolife

randomized in a 1:1 ratio to treatment :1 vial/day for 60 days.

DIETARY_SUPPLEMENT

Placebo

Placebo: 1 vial/day for 60 days.

Sponsors & Collaborators

  • University of Padova

    lead OTHER

Principal Investigators

  • Edoardo V Savarino · University of Padova

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2024-05-15
Primary Completion
2025-12-31
Completion
2026-06-15

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 NCT06642883 on ClinicalTrials.gov