Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06313346
Status:
RECRUITING
Last Update Posted:
2024-05-23
First Post:
2024-03-01
Brief Title:
Effect of a Probiotic on Microbiota Associated With the Immune System and Inflammation
Sponsor:
Clinica Universidad de Navarra Universidad de Navarra
Organization:
Clinica Universidad de Navarra Universidad de Navarra
Study Overview
Official Title:
Effect of a Probiotic Consumption on Microbiota Associated With the Immune System and Inflammation in Adult Women and Men FLORABIOTIC INMUNITARIO
Status:
RECRUITING
Status Verified Date:
2023-12
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:
FLORABIOTIC
Brief Summary:
The goal of this randomized clinical trial is to learn about the effect of consuming a probiotic on the microbiota associated with immune health and inflammation in healthy women and men after 6 weeks of intervention
The main questions to answer are
1 To study changes in the intestinal microbiota associated with immune health and inflammation related to probiotic intake
2 To evaluate changes in salivary cortisol after ingestion of the probiotic
3 To compile the number and intensity of catarrhal episodes suffered by the participants along the study
For this purpose a randomized double blind parallel study has been designed
Target sample size is 60 subjects
Participants will be allocated in two groups for 6 weeks
Experimental group n30 daily consumption of one probiotic capsule
Placebo group n30 daily consumption of one placebo capsule
The main questions to answer are
1 To study changes in the intestinal microbiota associated with immune health and inflammation related to probiotic intake
2 To evaluate changes in salivary cortisol after ingestion of the probiotic
3 To compile the number and intensity of catarrhal episodes suffered by the participants along the study
For this purpose a randomized double blind parallel study has been designed
Target sample size is 60 subjects
Participants will be allocated in two groups for 6 weeks
Experimental group n30 daily consumption of one probiotic capsule
Placebo group n30 daily consumption of one placebo capsule
Detailed Description:
Volunteers who wish to participate in the study will be interviewed by phone to verify that they meet the main inclusion criteria Volunteers who meet the main inclusion criteria will be invited to an information and screening visit to resolve any doubts Volunteers who agree to participate in the study will sign the informed consent and will be randomly allocated to one of the two arms of the study and will be provided with any required material
During the intervention volunteers will attend two Clinical investigation visits The first one will be carried out on the first day of the study and the last one will take place at the end of the 6 weeks In both visits anthropometric and body composition measurements stool and saliva samples as well as data about dietary physical activity and catarrhal episodes will be taken
During the intervention volunteers will attend two Clinical investigation visits The first one will be carried out on the first day of the study and the last one will take place at the end of the 6 weeks In both visits anthropometric and body composition measurements stool and saliva samples as well as data about dietary physical activity and catarrhal episodes will be taken
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