Ignite Creation Date:
2024-05-06 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06248177
Status:
RECRUITING
Last Update Posted:
2024-05-09
First Post:
2024-01-31
Brief Title:
Probiotic Effect on Gastrointestinal Symptoms FLORABIOTIC REFUERZO
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 Gastrointestinal Symptoms in Adults Men and Women FLORABIOTIC REFUERZO
Status:
RECRUITING
Status Verified Date:
2024-01
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 evaluate the effect on the microbiota and the reduction in the number andor intensity of symptoms of gastrointestinal discomfort of consuming a probiotic or placebo for 6 weeks in adult women and men
The main questions to answer are
1 To study changes in the alpha diversity of the microbiota
2 To evaluate changes in the salivary cortisol
For this purpose a randomized double blind crossover study has been designed
Target sample size is 30 subjects
Participants will be allocated in two groups for 16 weeks 6 weeks consuming one of the products 4 weeks wash-out period 6 weeks consuming the other product
Group 1 n15 6 weeks daily consumption of one probiotic capsule 4 weeks wash-out period 6 weeks daily consumption of one placebo capsule
Group 2 n15 6 weeks daily consumption of one placebo capsule 4 weeks wash-out period 6 weeks daily consumption of one probiotic capsule
The main questions to answer are
1 To study changes in the alpha diversity of the microbiota
2 To evaluate changes in the salivary cortisol
For this purpose a randomized double blind crossover study has been designed
Target sample size is 30 subjects
Participants will be allocated in two groups for 16 weeks 6 weeks consuming one of the products 4 weeks wash-out period 6 weeks consuming the other product
Group 1 n15 6 weeks daily consumption of one probiotic capsule 4 weeks wash-out period 6 weeks daily consumption of one placebo capsule
Group 2 n15 6 weeks daily consumption of one placebo capsule 4 weeks wash-out period 6 weeks daily consumption of one probiotic 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 4 visits distributed in two phases of 6 weeks separated by 4 weeks of wash-out period At the beginning and at the end of each phase there will be a clinical visit In all visits anthropometric and body composition measurements stool and saliva samples as well as data about dietary and physical activity will be collected
During the intervention volunteers will attend 4 visits distributed in two phases of 6 weeks separated by 4 weeks of wash-out period At the beginning and at the end of each phase there will be a clinical visit In all visits anthropometric and body composition measurements stool and saliva samples as well as data about dietary and physical activity will be collected
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