Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2025-12-27 @ 11:21 PM
Study NCT ID:
NCT05663060
Status:
COMPLETED
Last Update Posted:
2024-08-06
First Post:
2022-12-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation Study of the Intestinal Microbiota and Quality of Life in Patients Suffering From IBS Treated With Bifidice
Sponsor:
Istituto Clinico Humanitas
Organization:
Study Overview
Official Title:
Evaluation Study of the Intestinal Microbiota and Quality of Life in Patients Suffering From Irritable Bowel Syndrome Treated With Bifidice
Status:
COMPLETED
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Bifidice01
Brief Summary:
Irritable bowel syndrome is the most common functional gastrointestinal disease and is characterized by high prevalence and chronic course.The pathology has a strong impact on the quality of life of affected patients and on health and social costs, these related to reduced productivity.The scarce efficacy and heavy side effects of traditional therapies lead these patients to often resort to alternative or complementary therapies. From the evaluation of the evidence of various probiotic preparations and food supplements, the investigators have used a commercial preparation characterized by the presence of bifidobacteria which have demonstrated some efficacy in thinking of improving the quality of life of these patients to evaluate quality of life, ability productivity and trend of some indices of disease severity in a small number of patients. These preliminary data could represent a starting point for more in-depth evaluations, also with placebo-controlled studies.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: