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

NCT06642883 | Recruiting

• 1 other identifier: 5890/AO/23
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Microbiota, Probiotics

Outcome Measures

Primary Outcomes (1)

• Evaluation of the gut microbiota composition variation (microbiota test)

  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 Outcomes (1)

• Evaluation of gut microbiota pathways variation ( Picrust analysis)

  The microbiota analysis period, after 16S analysis: 2 months

Other Outcomes (2)

• Evaluation of clinical parameters variation ( Fecal calprotectin stool test)

  From enrolment to the end of analysis: 2-3 months

• Evaluation of clinical parameters (IBDQ-32 questionnaire)

  from the enrolment to the end of analysis: 2-3 months

Study Arms (2)

Prolife 10 Forte

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

Treatment 1dose/die ( All additional components except probiotics and vitamins)

Dietary Supplement: Placebo

Interventions

Prolife DIETARY_SUPPLEMENT

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

Prolife 10 Forte

Placebo DIETARY_SUPPLEMENT

Placebo: 1 vial/day for 60 days.

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Padova: lead

Study Sites (1)

Edoardo Vincenzo Savarino

Padua, Padua, 35128, Italy

RECRUITING

Study Officials

• Edoardo V Savarino

  University of Padova

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Edoardo V. Savarino, Prof.MD; PhD

CONTACT

0498218720; edoardo.savarino@unipd.it

Sonia Facchin, PhD

CONTACT

0498218720; sonia.facchin@unipd.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Model Details: This is a double-blind, placebo-controlled, randomized trial in which the enrolled subjects will be included in one year. After the written informed consent collection, subjects will be randomized in a 1:1 ratio to the Group 1 or Group 2: * Group 1 will take Treatment A: 1 vial/day of PROLIFE 10 FORTE for 60 days. * Group 2 will take the Treatment B: 1 vial/day of placebo for 60 days. We will enroll 70 UC patients in the remission phase, both males and females, with a diagnosis of Ulcerative Colitis for at least three months. The therapy undertaken could not be changed nor stopped during the probiotic administration

Study Record Dates

• First Submitted: September 9, 2024
• First Posted: October 15, 2024
• Study Start: May 15, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 15, 2026
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)