Probiotic Detection and Persistence Study
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|ClinicalTrials.gov Identifier: NCT04065503|
Recruitment Status : Active, not recruiting
First Posted : August 22, 2019
Last Update Posted : January 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Biological: Probiotic Strains||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Detection and Persistence of a Product Containing L. Helveticus R-0052, L. Casei HA-108, B. Breve HA-129, B. Longum R-0175 and S. Thermophilus HA-110 in Healthy Adults: an Open-label Pilot Study.|
|Actual Study Start Date :||December 6, 2019|
|Estimated Primary Completion Date :||September 2020|
|Estimated Study Completion Date :||September 2021|
Experimental: Healthy Adults
Healthy adults will be given probiotic strains to evaluate the detection and persistence of the strains in the participant's feces.
Biological: Probiotic Strains
A commercial product containing L. helveticus R0052, L. casei HA-108, B. breve HA-129, and B. longum R0175 and S. thermophilus HA-110 be given to healthy adults across a 10-week open label pilot study.
- Change in time to detection of probiotic strains [ Time Frame: Day 1; Day 2; Day 3, Day 4, Day 7, Day 10 ]using strain-specific qPCR assays.
- Change in time to non-detection (persistence) of probiotic strains [ Time Frame: Day 14, Day 15, Day 16, Day 17, Day 18, Day 21, Day 24, Day 28, Day 35, Day 42 ]using strain-specific qPCR assays.
- Whole gut transit time [ Time Frame: Day 1, Day 2, Day 3, Day 4 ]Whole gut transit time measured by radiopaque marker recovery in intervention stools
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04065503
|United States, Florida|
|Food Science and Human Nutrition Department|
|Gainesville, Florida, United States, 32611|
|Principal Investigator:||Wendy Dahl||University of Florida|