Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-27 @ 11:48 PM
Study NCT ID:
NCT05073393
Status:
COMPLETED
Last Update Posted:
2022-08-23
First Post:
2021-10-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Probiotics on Oral Homeostasis During Sugar Stress
Sponsor:
University of Copenhagen
Organization:
Study Overview
Official Title:
Effect of Probiotics on Oral Homeostasis During Sugar Stress
Status:
COMPLETED
Status Verified Date:
2022-08
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:
None
Brief Summary:
The present study is a double-blinded randomized clinical trial with a duration of 28 days.
Detailed Description:
The present study is a double-blinded randomized clinical trial with a duration of 28 days.
80 orally and systemically healthy participant will be allocated in the test (probiotic) and the control (placebo) group at baseline.
The intervention is sugar stress, which will be applied at baseline and continue through day 14, followed by 14 days without sugar stress.
Clinical measurements and sampling will be performed at baseline, day 14 and day 28
Primary endpoint: Changes in microbial composition.
Secondary endpoints: Changes in clinical and immunological parameters
80 orally and systemically healthy participant will be allocated in the test (probiotic) and the control (placebo) group at baseline.
The intervention is sugar stress, which will be applied at baseline and continue through day 14, followed by 14 days without sugar stress.
Clinical measurements and sampling will be performed at baseline, day 14 and day 28
Primary endpoint: Changes in microbial composition.
Secondary endpoints: Changes in clinical and immunological parameters
Study Oversight
Has Oversight DMC:
True
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?: