Evaluation of ProLife 10 FORTE on Gut Microbiota Composition in UC Patients (ProZ-UC)

October 14, 2024 updated by: Savarino Edoardo Vincenzo, University of Padova

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Ulcerative colitis (UC) is a chronic, idiopathic inflammatory disease that affects the colon. It is characterized by relapsing and remitting mucosal inflammation, and it can either affect only the rectum or extend along the colon. It is known that the gut microbiota also affects UC pathology. When its composition is altered, some microbiota-dependent mechanisms may be lost, resulting in an unbalanced relationship with the host: this condition is known with the name dysbiosis.Differences in gut microbiome composition and function have been associated with a variety of chronic diseases ranging from gastrointestinal inflammatory and metabolic conditions to neurological, cardiovascular, and respiratory illnesses.

Some trials have already been performed to understand if probiotics can also help in the UC management. For what concerns the human population, the literature contains many studies performed to evaluate the effect of different products on active or remitting disease. Most of the available literature is related to the use of a multiple-strain probiotic demonstrated that probiotic strains led to remission in some UC patients, with significant improvement in rectal bleeding and stool frequency, mucosal appearance, and clinical evaluation.

Prolife 10 FORTE has already been tested by our team to evaluate its composition and its ability to reach the gut, with positive results (unpublished data). Our team has performed the Shotgun analysis of the Prolife 10 FORTE that has confirmed the presence of all 10 strains of probiotics. The metabolic parameters of the product were also analyzed, highlighting a potential enrichment in the production of SCFA and in the fermentative pathways' degradation of starches, the biosynthesis of deoxyribonucleotides, and vitamins B2, B9, K, etc...

Thus, considering these positive premises, we now want to verify if Prolife 10 FORTE could improve the Gut Microbiota composition of UC patients during the remission phase.

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Exclusion Criteria:

  • Patients with active UC are determined by clinical, endoscopic, and histopathological evidence.
  • Known diagnosis of CD, indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis or microscopic colitis.
  • Positive stool culture for active C. difficile.
  • Pregnant women.
  • Allergy to soy or fructose (contained in Prolife 10 FORTE)
  • Patients under antibiotic and/or probiotic treatment within 10 days before visit1.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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).
Dietary supplement: Prolife
randomized in a 1:1 ratio to treatment :1 vial/day for 60 days.
Placebo Comparator: Placebo
Treatment 1dose/die ( All additional components except probiotics and vitamins)
Dietary supplement: Placebo
Placebo: 1 vial/day for 60 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the gut microbiota composition variation (microbiota test)
Time Frame: From enrollment to the end of treatment 8 weeks
Collection of fecal samples to assess the fecal microbiota composition ( rRNA16S) The 16S rRNA gene is a bacterial ribosomal gene and a part of the 30S subunit used in the identification, characterization, and classification of various bacteria. Samples were normalized, pooled, and run on Illumina MiSeq, to evaluate the composition of gut microbiota in terms of bacterial diversity ( alfa and beta) and abundance and any variability associated with the treatment.
From enrollment to the end of treatment 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of gut microbiota pathways variation ( Picrust analysis)
Time Frame: The microbiota analysis period, after 16S analysis: 2 months
PICRUSt (Phylogenetic Investigation of Communities by Reconstruction of Unobserved States) is a bioinformatics tool used to predict the genetic functions of microbial communities based on DNA sequencing data.
The microbiota analysis period, after 16S analysis: 2 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of clinical parameters variation ( Fecal calprotectin stool test)
Time Frame: From enrolment to the end of analysis: 2-3 months
The patient undergoes fecal calprotectin analysis assessment before and after the 60-day treatment. (cut-off value 50ug/g)
From enrolment to the end of analysis: 2-3 months
Evaluation of clinical parameters (IBDQ-32 questionnaire)
Time Frame: from the enrolment to the end of analysis: 2-3 months
The patient undergoes IBDQ questionnaire assessment before and after the 60-day treatment. ( IBDQ-32 score; cut-off 170 pt.)
from the enrolment to the end of analysis: 2-3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Padova

Investigators

  • Principal Investigator: Edoardo V Savarino, University of Padova

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2024

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

June 15, 2026

Study Registration Dates

First Submitted

September 9, 2024

First Submitted That Met QC Criteria

October 14, 2024

First Posted (Actual)

October 15, 2024

Study Record Updates

Last Update Posted (Actual)

October 15, 2024

Last Update Submitted That Met QC Criteria

October 14, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5890/AO/23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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