Evaluation of the Effects of 10-strain Probiotic (ProLife 10 FORTE) on Gut Microbiota Composition in Patients Presenting with Ulcerative Colitis During the Remission Phase

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

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 the subject to participate fully in all aspects of this clinical trial.

Locations
Other Locations
Italy
Edoardo Vincenzo Savarino
RECRUITING
Padua
Contact Information
Primary
Edoardo V. Savarino, Prof.MD; PhD
edoardo.savarino@unipd.it
0498218720
Backup
Sonia Facchin, PhD
sonia.facchin@unipd.it
0498218720
Time Frame
Start Date: 2024-05-15
Estimated Completion Date: 2026-06-15
Participants
Target number of participants: 70
Treatments
Active_comparator: Prolife 10 Forte
Treatment: 1 dose/die (contains 10 ml with: in particular, 7 strains of Lactobacillus (L. casei R215, L. plantarum Lp-115, L. helveticus R0052, L. acidophilus La-14, L. gasseri Lg-36, L. brevis Lbr-35, L. rhamnosus HN001), 2 strains of Bifidobacteria (B. lactis Bl-04 and HN019) and Bacillus coagulans BC4. In addition, it contains 10 mg of glucoligosaccharide and a pool of Vitamin B (B1, B2, B6, B12).
Placebo_comparator: Placebo
Treatment 1dose/die ( All additional components except probiotics and vitamins)
Sponsors
Leads: University of Padova

This content was sourced from clinicaltrials.gov

Similar Clinical Trials