Clinical trial NCT06642883: Evaluation of ProLife 10 FORTE on Gut Microbiota Composition in UC Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ulcerative Colitis in Remission
Keywords: Microbiota, Probiotics
Lead sponsor: University of Padova
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluation of the gut microbiota composition variation (microbiota test)
timeFrame: From enrollment to the end of treatment 8 weeks
Secondary outcomes:
measure: Evaluation of gut microbiota pathways variation ( Picrust analysis)
timeFrame: The microbiota analysis period, after 16S analysis: 2 months
Other outcomes:
measure: Evaluation of clinical parameters variation ( Fecal calprotectin stool test)
timeFrame: From enrolment to the end of analysis: 2-3 months
measure: Evaluation of clinical parameters (IBDQ-32 questionnaire)
timeFrame: from the enrolment to the end of analysis: 2-3 months
Locations:
city: Padua
country: Italy
facility: Edoardo Vincenzo Savarino
Study officials:
affiliation: University of Padova
name: Edoardo V Savarino
role: PRINCIPAL_INVESTIGATOR
References: