Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06610149
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-17
Brief Title:
A Novel Probiotic Mixture in Adults With IBS
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Multicenter Real-World Single-Arm Open-Label Study Assessing the Impact of Novel Probiotic Mixture on the Symptoms of Irritable Bowel Syndrome in Adults
Status:
COMPLETED
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:
IBS-dammil5
Brief Summary:
Irritable bowel syndrome IBS is faced by gastroenterologists on a daily basis and probiotics are a potential therapeutic tool however there is no strain recommendations This multicenter re-al-world single-arm open-label study aims to assess the effectiveness safety and patient satis-faction of a novel probiotic mixture in patients with IBS Methods This study is conducted by Italian gastroenterologists who enroll patients with IBS Throughout the 8-week treatment T1 period with a probiotic mixture Lactobacillus paracasei 10137 LMG P-17504 Lac-tobacillus plantarum 14D CECT 4528 Bifidobacterium breve Bbr8 LMG P-17501 Bifidobacterium breve BL10 LMG P-17500 and Bifidobacterium animalis ssp lactis Bi1 LMG P-17502 participants complete a questionnaire to evaluate IBS symptoms at baseline at the end of treatment and after one-month follow-up T2
Detailed Description:
Irritable bowel syndrome IBS is faced by gastroenterologists on a daily basis and probiotics are a potential therapeutic tool however there is no strain recommendations This multicenter re-al-world single-arm open-label study aims to assess the effectiveness safety and patient satis-faction of a novel probiotic mixture in patients with IBS Methods This study is conducted by Italian gastroenterologists who enroll patients with IBS Throughout the 8-week treatment T1 period with a probiotic mixture Lactobacillus paracasei 10137 LMG P-17504 Lac-tobacillus plantarum 14D CECT 4528 Bifidobacterium breve Bbr8 LMG P-17501 Bifidobacterium breve BL10 LMG P-17500 and Bifidobacterium animalis ssp lactis Bi1 LMG P-17502 participants complete a questionnaire to evaluate IBS symptoms at baseline at the end of treatment and after one-month follow-up T2
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