Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06609148
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-20
Brief Title:
Probiotic in Patients With Bile Acid MalabsorptionDiarrhea
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Randomized Double-Blind Placebo-Controlled Trial of De Simone Formulation Probiotic in Patients With Bile Acid MalabsorptionDiarrhea Unassociated With Ileal Resection
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:
The purpose of this study is to assess effect of the DSF probiotic on fecal bile acid levels in patients with BAM
Detailed Description:
In this placebo-controlled trial the De Simone combination probiotic formulation will be tested in 12 patients in each treatment arm The patients will be previously diagnosed with bile acid diarrhea The objective is to assess the effects of this probiotic on fecal blood low acid levels in patients with bile acid diarrhea Secondary objectives are to evaluate changes in primary fecal bile acids in a single stool sample serum 7 alpha C4 intestinal permeability stool consistency and frequency fecal short chain fatty acids and fecal micro biome composition and diversity
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