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| Name | Class |
|---|---|
| Atlantia Food Clinical Trials | INDUSTRY |
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This trial is a single-site, randomised, double-blind, placebo-controlled, two-armed, parallel-group trial in healthy, adult volunteers. The trial will investigate the effect of daily intake of a probiotic strain versus placebo when co-administered to daily intake of 300mg of Aspirin. The objective is to investigate the ability of the probiotic strain to attenuate and/or reverse Aspirin-induced deterioration of the small intestine.
The trial includes a run-in period of two weeks duration followed by a six weeks intervention period where a probiotic strain/placebo and Aspirin is co-administered. After the 6 weeks, probiotic strain/placebo is given for two additional weeks to investigate the potential effects of the probiotic strain on intestinal healing after long-time Aspirin use.
Subjects will participate in the trial for a total duration of 10 weeks including the run-in phase. Besides the screening visit, the trial will consist of 6 visits.
After having given their written informed consent, subjects will complete 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 Aspirin and also be randomly assigned to 8 weeks daily intake of active or placebo product in a ratio of 1:1.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| probiotic strain | Experimental | Active arm treated with the probiotic strain for 8 weeks. |
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| Placebo | Placebo Comparator | Placebo arm treated with placebo capsules (identical to active product capsule besides the bacteria) for 8 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| probiotic strain | Dietary Supplement | 8 weeks of treatment with probiotic strain |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Lewis score from capsule endoscopy | The effect of 8 weeks oral supplementation of probiotic strain versus placebo on small intestinal mucosa damage when co-administered to a 6 week Aspirin challenge measured as the area-under-the-curve of the capsule endoscopy Lewis score between Visit 2 (randomization) and Visit 7 (end of treatment). | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mucosal ulcer number | The effect of 8 weeks oral supplementation of probiotic strain versus placebo on small intestinal mucosa damage when co-administered to a 6 week Aspirin challenge measured as the area-under-the-curve of the capsule endoscopy mucosal total ulcer number between Visit 2 (randomization) and Visit 7 (end of treatment). | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martin Buckley, Dr | GI Physiology Laboratory, Mercy University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atlantia Food Clnical Trials | Cork | T23 R50R | Ireland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31095949 | Derived | Mortensen B, Murphy C, O'Grady J, Lucey M, Elsafi G, Barry L, Westphal V, Wellejus A, Lukjancenko O, Eklund AC, Nielsen HB, Baker A, Damholt A, van Hylckama Vlieg JET, Shanahan F, Buckley M. Bifidobacteriumbreve Bif195 Protects Against Small-Intestinal Damage Caused by Acetylsalicylic Acid in Healthy Volunteers. Gastroenterology. 2019 Sep;157(3):637-646.e4. doi: 10.1053/j.gastro.2019.05.008. Epub 2019 May 13. |
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Aspirin challenge model
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| Placebo |
| Dietary Supplement |
8 weeks of treatment |
|
| Pain module score of the GSRS questionnaire | The effect of 8 weeks oral supplementation of probiotic strain versus placebo on gastrointestinal symptoms when co-administered to a 6 week Aspirin challenge measured as the area-under-the-curve of pain module score of the GSRS questionnaire between Visit 2 (randomization) and Visit 7 (end of treatment). | 8 weeks |
| Blood I-FABP concentration | The effect of 8 weeks oral supplementation of probiotic strain versus placebo on small intestinal mucosa damage when co-administered to a 6 week Aspirin challenge measured as the area-under-the-curve for Visit 2-Visit 7 blood I-FABP concentration. | 8 weeks |
| Total score of the GSRS questionnaire | The effect of 8 weeks oral supplementation of probiotic strain versus placebo on gastrointestinal symptoms when co-administered to a 6 week Aspirin challenge measured as the area-under-the-curve of total score of the GSRS questionnaire between Visit 2 (randomization) and Visit 7 (end of treatment). | 8 weeks |
| Mucosal red spots number | The effect of 8 weeks oral supplementation of probiotic strain versus placebo on small intestinal mucosa damage when co-administered to a 6 week Aspirin challenge measured as the area-under-the-curve of the capsule endoscopy mucosal red spot number between Visit 2 (randomization) and Visit 7 (end of treatment). | 8 weeks |
| Feces Calprotectin concentration. | The effect of 8 weeks oral supplementation of probiotic strain versus placebo on small intestinal mucosa damage when co-administered to a 6 week Aspirin challenge measured as the area-under-the-curve for Visit 2-Visit 7 feces Calprotectin concentration. | 8 weeks |
| blood Calprotectin concentration | The effect of 8 weeks oral supplementation of probiotic strain versus placebo on small intestinal mucosa damage when co-administered to a 6 week Aspirin challenge measured as the area-under-the-curve of the blood Calprotectin concentration between Visit 2 (randomization) and Visit 7 (end of treatment). | 8 weeks |