Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06619067
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-09-26
Brief Title:
Efficacy Study of the Probiotic Food Supplement PROBAFLOR for Maintaining Intestinal Well-being
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efficacy Study of the Probiotic Food Supplement PROBAFLOR for Maintaining Intestinal Well-being Single-centre Controlled Randomized Parallel Group Double-blind Clinical Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
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:
PROBAFLOR
Brief Summary:
It is now known that intestinal health has a strong influence on the entire body Recent research advances have demonstrated the involvement of the intestinal microbiota in the well-being of the intestine Preventive medicine is increasingly perceived as important in medical and economic terms particularly in the field of gastroenterology An innovative approach to support gut health is based on the use of modulators of the intestinal microbiome or gastrointestinal barrier such as probiotics or prebiotics The rationale for this study is therefore based on the hypothesis that the combination of 11 probiotic strains conveyed through the PROBAFLOR food supplement can play a positive role in maintaining normal intestinal function bringing benefits to the subject who takes this supplement
Detailed Description:
This is a randomized double-blind placebo-controlled intervention study with a duration of 3 months of intervention 1 month of follow-up on biological samples Eligible participants will be randomized and receive either the probioic or placebo supplement to consume daily for 3 months Three check-in visits will occur one at the screening the second one afetr the 3-months intervention and the final one after 1 month of followup Participants will be expected to complete a daily study diary documenting their investigational product useadverse events and a daily bowel habits diary documenting each bowel movement Stool samples and questionnaires will be completed for study outcome analysis
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