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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:
Participants will:
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already been tested by our team to evaluate its composition and its ability to reach the gut, with positive results (unpublished data).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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Placebo | Placebo Comparator | Treatment 1dose/die ( All additional components except probiotics and vitamins) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prolife | Dietary Supplement | randomized in a 1:1 ratio to treatment :1 vial/day for 60 days. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of gut microbiota pathways variation ( Picrust analysis) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of clinical parameters variation ( Fecal calprotectin stool test) | 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) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Edoardo V. Savarino, Prof.MD; PhD | Contact | 0498218720 | 0039 | edoardo.savarino@unipd.it |
| Sonia Facchin, PhD | Contact | 0498218720 | 0039 | sonia.facchin@unipd.it |
| Name | Affiliation | Role |
|---|---|---|
| Edoardo V Savarino | University of Padova | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Edoardo Vincenzo Savarino | Recruiting | Padua | Padua | 35128 | Italy |
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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:
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
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Double-blind
| Placebo | Dietary Supplement | Placebo: 1 vial/day for 60 days. |
|
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 |