Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06642883
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-09
Brief Title:
Evaluation of ProLife 10 FORTE on Gut Microbiota Composition in UC Patients
Sponsor:
None
Organization:
None
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ProZ-UC
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 vialday of Prolife 10 Forte Placebo for 60 days
Visit the clinic two times for checkups Questionaire and tests
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 vialday 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 dysbiosisDifferences 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None