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NCT04448847: PIP-M
Mapping the MoA Behind GI Protection From Bif195
NA trial testing Bif195 in Reduction of Small Intestinal Ulceration Risk in 25 participants. Completed in 12 January 2021.
12 January 2021
Quick facts
| Lead sponsor | Chr Hansen |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | quadruple |
| Primary purpose | prevention |
| Enrollment | 25 |
| Start date | 8 June 2020 |
| Primary completion | 12 January 2021 |
| Estimated completion | 12 January 2021 |
| Sites | 1 location across Denmark |
Drugs / interventions tested
- Bif195
- Placebo
Conditions studied
- Reduction of Small Intestinal Ulceration Risk — all drugs for Reduction of Small Intestinal Ulceration Risk →
Sponsor
Chr Hansen — full company profile →
Who can join
Adults 18 to 40, any sex, with Reduction of Small Intestinal Ulceration Risk. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The trial will investigate effects of daily intake of the bacterial strain Bif195 or placebo when co-administered to once-daily oral intake of 300 mg of Acetylsalicylic Acid (ASA). The trial includes a run-in period of two weeks duration followed by a 4-week intervention period in which Bif195/placebo and ASA are co-administered. This period is followed by a 6-week wash-out period before a new 4-week period is performed with a cross-over Bif195/placebo intervention as well as ASA co-administration. Bif195 and placebo interventions are performed double-blinded in randomised order in a cross-over fashion for each subject.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04448847
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Bif195
Trials testing the same drug.
- NCT04447924 — The Effect of a Probiotic Strain on Ibuprofen-induced GI Damage · NA · completed
- NCT03910322 — The Effect of a Probiotic Strain on Aspirin-induced GI Damage · NA · terminated
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 NCT04448847 (US National Library of Medicine, public domain)
- 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: 24 April 2023
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/NCT04448847.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing