Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00135031
Status:
COMPLETED
Last Update Posted:
2011-06-15
First Post:
2005-08-23
Brief Title:
Efficacy of an Encapsulated Probiotic Bifidobacterium Infantis 35624 in Irritable Bowel Syndrome
Sponsor:
Procter and Gamble
Organization:
Procter and Gamble
Study Overview
Official Title:
A Multicenter Double-Blind Randomized Placebo-Controlled Dose-Ranging Safety and Efficacy Evaluation of Bifidobacterium Infantis 35624 in Female Subjects With Irritable Bowel Syndrome
Status:
COMPLETED
Status Verified Date:
2011-06
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:
None
Brief Summary:
The purpose of this study was to determine the dose-ranging efficacy and safety profile of encapsulated Bifidobacterium infantis 35624 in female subjects with irritable bowel syndrome IBS
Detailed Description:
The pathogenesis of irritable bowel syndrome IBS may have a a post-infectious inflammatory component suggesting that altered gut bacterial flora are of relevance and that probiotics may be beneficial This clinical trial examined the efficacy of an encapsulated probiotic in subjects with Rome II IBS After a 2 week baseline 362 female subjects were randomized to placebo or one of three doses of B infantis 35624 once daily for 4 weeks IBS symptoms were monitored daily and scored according to a 6-point Likert scale stool frequency and form were also monitored daily The primary efficacy variable was the abdominal pain score secondary efficacy variables included other IBS symptom relief and quality of life
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