Ignite Creation Date:
2024-07-17 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06475183
Status:
RECRUITING
Last Update Posted:
2024-07-01
First Post:
2024-06-20
Brief Title:
Probiotic Chocolate Study in Multiple Sclerosis
Sponsor:
Columbia University
Organization:
Columbia University
Study Overview
Official Title:
Effects of Probiotics on Inflammatory Biomarkers in Persons With Multiple Sclerosis MS and in Family Members of Persons With MS
Status:
RECRUITING
Status Verified Date:
2024-06
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:
ProChocolate
Brief Summary:
The goal of this study is to assess the effects of probiotics on persons with multiple sclerosis MS persons at higher genetic risk for MS first degree family members of persons with MS and healthy controls Participants will be asked to consume probiotic containing chocolates Bouchard Belgian Dark Chocolate Probiotic Napolitains containing 10 billion CFUs of bifidobacterium longum per day for 6 weeks Participants will undergo blood draws before and after the 6 weeks of probiotic containing chocolate and microbial metabolites and immune markers will be compared before and after the probiotics as well as between groups
Detailed Description:
The goal of this study is to assess the effects of probiotics in persons with MS PwMS persons at high genetic risk for MS first degree family members of PwMS and healthy controls PwMS Subjects undergo blood draws and will complete surveys on neurological symptoms as relevant Subjects are given a supply of individually wrapped probiotic containing chocolates Bouchard Belgian Dark Chocolate Probiotic Napolitains along with instructions on proper storage dosage and a diary to complete regarding supplement adherence After a ramp up period of 3 days during which participants will consume take 2 chocolates per day participants consume 5 chocolates per day 10 billion CFUs of bifidobacterium longum per day for 6 weeks After 6 weeks participants return the adherence diaries and answer questions about probiotic tolerance They also repeat similar surveys and again undergo blood draws Serum levels of microbial metabolites and peripheral blood immune profiles are assessed before and after supplementation
Study Oversight
Has Oversight DMC:
None
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?:
None