Last reviewed · How we verify
NCT03228589: PIP-D
The Effect of a Probiotic Strain on Aspirin-induced GI Damage.
Phase 2 trial testing probiotic strain in Side Effects of Acetylsalicylic Acid Use in 109 participants. Completed in 4 April 2018.
21 December 2017
Quick facts
| Lead sponsor | Chr Hansen |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | prevention |
| Enrollment | 109 |
| Start date | 15 July 2017 |
| Primary completion | 21 December 2017 |
| Estimated completion | 4 April 2018 |
| Sites | 1 location across Ireland |
Drugs / interventions tested
- probiotic strain
- Placebo
Conditions studied
- Side Effects of Acetylsalicylic Acid Use — all drugs for Side Effects of Acetylsalicylic Acid Use →
Sponsor
Chr Hansen — full company profile →
Who can join
Adults 18 to 40, any sex, with Side Effects of Acetylsalicylic Acid Use. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Bifidobacteriumbreve Bif195 Protects Against Small-Intestinal Damage Caused by Acetylsalicylic Acid in Healthy Volunteers.
Mortensen B, Murphy C, O'Grady J, Lucey M, et al · · 2019 · cited 49× · PMID 31095949 · DOI 10.1053/j.gastro.2019.05.008 -
Bringing microbiome-drug interaction research into the clinic.
Guthrie L, Kelly L. · · 2019 · cited 48× · PMID 31151933 · DOI 10.1016/j.ebiom.2019.05.009 -
Defining gastrointestinal transit time using video capsule endoscopy: a study of healthy subjects.
O'Grady J, Murphy CL, Barry L, Shanahan F, et al · · 2020 · cited 27× · PMID 32118112 · DOI 10.1055/a-1073-7653
Verify or expand the search:
- PubMed search for NCT03228589
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Chr Hansen trials
Trials by the same sponsor.
- NCT05840978 — Effect of Probiotics on Stress in Young Adults · NA · completed
- NCT05564767 — Effect of Two Probiotic Formulations on Mental Health and Mood Biomarkers in Adults With Depressive Symptoms · NA · completed
- NCT05529693 — Efficacy of a Probiotic Strain on Level of Markers of Inflammation in an Elderly Population · NA · completed
- NCT04987593 — Characterisation of the Gut Microbiota in Term Infants After Maternal Supplementation of Probiotics · NA · completed
- NCT04994834 — Characterization of the Gastrointestinal Microbiota in Term Newborn Infants After 4 Weeks Supplementation of Probiotics · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03228589 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Chr Hansen
- Last refreshed: 3 May 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03228589.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing