Reduction of Small Intestinal Ulceration Risk Clinical Trial
Official title:
The Effect of Daily Intake of Two Different Doses of Bif195 on Small-intestinal Damage Induced by Acetylsalicylic Acid- a Randomized, Double-blind, Placebo-controlled, Three-armed, Parallel Group Trial in Healthy Volunteers.
The primary objective of this trial is to investigate if a daily dose of minimum 50 billion CFU of Bif195 reduces the risk of small-intestinal tissue damage in an acetylsalicylic acid challenge model as assessed by video capsule endoscopy in a healthy US population aged 40 - 60 years.
This trial is a single-site, randomized, double-blind, placebo-controlled, three-armed,
parallel-group trial in healthy volunteers aged 40 - 60 years. The trial will investigate the
effect of daily intake of the probiotic strain Bif195 in two different doses or placebo when
co-administered to daily intake of 300mg of Acetylsalicylic Acid (ASA).
The trial includes a run-in period of two weeks duration followed by a six weeks intervention
period where Bif195/placebo and ASA is co-administered.
Subjects will participate in the trial for a total duration of 8 weeks including the run-in
phase. Besides the screening visit, the trial will consist of 5 visits.
After having given their written informed consent, subjects will complete the screening
procedures to evaluate their eligibility for participation in the trial and complete a run-in
period of two weeks duration to washout possible pre-trial probiotics and/or use of
medication. After baseline assessments at Visit 2, subjects will start daily intake of 300mg
ASA and also be randomly assigned to 6-weeks daily intake of low or high-dose active (Bif195)
or placebo product in a ratio of 1:1:1.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04448847 -
Mapping the MoA Behind GI Protection From Bif195
|
N/A | |
| Completed |
NCT04447924 -
The Effect of a Probiotic Strain on Ibuprofen-induced GI Damage
|
N/A |