Viewing Study NCT06595719



Ignite Creation Date: 2024-10-26 @ 3:40 PM
Last Modification Date: 2024-10-26 @ 3:40 PM
Study NCT ID: NCT06595719
Status: RECRUITING
Last Update Posted: None
First Post: 2024-09-03

Brief Title: Multi-Strain Probiotics Supplementation With Standard Care in Mild to Moderate Ulcerative Colitis
Sponsor: None
Organization: None

Study Overview

Official Title: Assessing Gut Microbiota Mucosal Healing Markers and Metabolites in Mild to Moderate Ulcerative Colitis Treated With Multi-Strain Probiotics
Status: RECRUITING
Status Verified Date: 2024-09
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: None
Brief Summary: Probiotics are one of the adjunctive treatments that have been extensively explored for Ulcerative colitis UC disease management Probiotics a group of beneficial bacteria can bring various health benefits when adequately supplied to the body especially for gut wellness In particular for UC patients gut dysbiosis is one of the contributing factors in their pathogenesis Thus the supplementation of probiotics in combination with standard treatment can potentially help in relieving symptoms as well as promoting mucosal healing for long-term remission
Detailed Description: Inflammatory bowel disease IBD has progressively risen globally becoming more prevalent in recent years Crohns disease CD and UC are classified as two of IBD variations resulting in range of symptoms that can negatively impact patients quality of life The underlying cause of UC is complicated encompassing genetic environmental and immunological factors Despite breakthroughs in medical treatment obtaining and maintaining remission in UC remains a substantial challenge especially for people with mild to moderate disease severity Standard treatment for UC consists of anti-inflammatory drugs antibiotics immunosuppressants and in severe instances biologic therapy and possibly surgery While these procedures have proven effective a significant proportion of patients endure ongoing symptoms or undesirable consequences emphasizing the need for alternative or supplementary therapeutic options

In recent years studies have focused on the gut microbiota as an important contributor in the pathophysiology of UC Individuals with UC frequently exhibit altered microbial composition and dysbiosis implying a possible role for gut microbiome-modulating therapies Probiotics which are live microorganisms that provide health advantages have emerged as a viable area for research in UC management The rationale for using probiotics in UC lies in their potential to restore microbial balance strengthen the intestinal barrier and modulate the immune response Previous studies have shown varying degrees of success with probiotics administration in terms of clinical and laboratory outcomes

This proposed research seeks to contribute to the growing body of knowledge on the role of probiotics in UC by evaluating the efficacy of a multi-strain probiotic supplement By combining these probiotics with standard care we aim to explore the synergistic effects that may lead to improved clinical outcomes endoscopic remission and enhanced quality of life in individuals with mild to moderate UC Understanding the impact of multi-strain probiotics on UC could provide clinicians with a valuable adjunctive tool for UC treatment strategies Furthermore elucidating the underlying mechanisms by which probiotics exert their effects enable better knowledge regarding the interplay between the gut microbiota and UC management Thus it can bring benefits to both patients and health institutions which helped in reducing the cost and maintaining long term remission

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