Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06639516
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-02
Brief Title:
Therapeutic Effect of Bifidobacterium Longum in Patients with Acute Pancreatitis a Randomized Double-Blind Placebo-Controlled Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Therapeutic Effect of Bifidobacterium Longum in Patients with Acute Pancreatitis a Randomized Double-Blind Placebo-Controlled Trial
Status:
NOT_YET_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:
The purpose of this clinical trial is to investigate the impact of Bifidobacterium longumBL on the clinical prognosis of patients with acute pancreatitisAP to analyze the correlation between BL and intestinal barrier function as well as the gut microbiota and to observe adverse reactions and risks in patients with AP after the use of BL
Participants will be randomly assigned to two groups the intervention group and the control group They will receive
Intervention group Standard clinical treatment BL capsules 1011 CFU twice a day for a total of 14 days
Control group Standard clinical treatment placebo capsules for a total of 14 days
A total of 60 patients will be included in this study
Participants will be randomly assigned to two groups the intervention group and the control group They will receive
Intervention group Standard clinical treatment BL capsules 1011 CFU twice a day for a total of 14 days
Control group Standard clinical treatment placebo capsules for a total of 14 days
A total of 60 patients will be included in this study
Detailed Description:
RationaleThe impairment of the intestinal mucosal barrier in patients with acute pancreatitis AP plays a crucial role in the progression to severe APSAP Our previous research found that the early gut microbiota structure of AP patients is significantly different from that of healthy individuals characterized by a marked increase in the relative abundance of conditional pathogens such as Escherichia coli and Shigella while beneficial bacteria that produce short-chain fatty acids such as Bifidobacterium are significantly reduced especially in patients with SAP Bifidobacterium longum BL a well-known probiotic has been used to treat a variety of diseases In our previous animal experiments we found that BL could alleviate pancreatic damage and inflammatory responses in AP mice and regulate the balance of the gut microbiota Based on these findings this study aims to assess the impact of BL on the clinical prognosis of AP patients through a randomized controlled trial in order to provide a scientific basis for the application of BL in the treatment of AP and to further explore its potential clinical value
Objective The purpose of this clinical trial is to investigate the impact of BL on the clinical prognosis of patients with AP to analyze the correlation between BL and intestinal barrier function as well as the gut microbiota and to observe adverse reactions and risks in patients with AP after the use of BL
Study design Single-center randomized double-blind placebo-controlled study
Study population60 adult patients with acute pancreatitis Intervention The intervention group receives standard clinical treatment plus BL capsules 1011 CFU twice a day for a total of 14 days the control group receives standard clinical treatment plus placebo capsules for a total of 14 days
Main study parametersendpoints The primary endpoint is the number of days without SIRS within 14 days the secondary endpoints include infectious complications including fungal infections parameters related to systemic inflammatory response intestinal barrier function and gut microbiota composition indicators related to recovery of intestinal function antibiotic use laboratory-related indicators and clinical outcomes
Safety Throughout the study or afterwards treatment-emergent adverse events TEAEs were recorded including gastrointestinal adverse reactions abdominal pain nausea vomiting bloating or diarrhea and allergic reactions and adverse events that led to discontinuation of the study drug were documented
Objective The purpose of this clinical trial is to investigate the impact of BL on the clinical prognosis of patients with AP to analyze the correlation between BL and intestinal barrier function as well as the gut microbiota and to observe adverse reactions and risks in patients with AP after the use of BL
Study design Single-center randomized double-blind placebo-controlled study
Study population60 adult patients with acute pancreatitis Intervention The intervention group receives standard clinical treatment plus BL capsules 1011 CFU twice a day for a total of 14 days the control group receives standard clinical treatment plus placebo capsules for a total of 14 days
Main study parametersendpoints The primary endpoint is the number of days without SIRS within 14 days the secondary endpoints include infectious complications including fungal infections parameters related to systemic inflammatory response intestinal barrier function and gut microbiota composition indicators related to recovery of intestinal function antibiotic use laboratory-related indicators and clinical outcomes
Safety Throughout the study or afterwards treatment-emergent adverse events TEAEs were recorded including gastrointestinal adverse reactions abdominal pain nausea vomiting bloating or diarrhea and allergic reactions and adverse events that led to discontinuation of the study drug were documented
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