Trials / Completed
CompletedNCT05118919
A Safety Study of Lactobacillus Reuteri BGP-014 in Patients With Ulcerative Colitis
A Randomised Placebo-controlled Safety Study of Lactobacillus Reuteri BGP-014 in Patients With Mild to Moderate Ulcerative Colitis
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 35 (actual)
- Sponsor
- BioGaia Pharma AB · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The objectives of this study are to evaluate the safety, tolerability and preliminary efficacy of Lactobacillus reuteri BGP-014 in mild to moderate active Ulcerative Colitis (UC) patients as an oral administered local treatment in addition to Standard of Care (SoC) treatment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | BGP-014 | Oral capsule containing lyophilised Lactobacillus reuteri |
| BIOLOGICAL | Placebo | Oral capsule |
Timeline
- Start date
- 2022-02-09
- Primary completion
- 2024-12-31
- Completion
- 2024-12-31
- First posted
- 2021-11-12
- Last updated
- 2025-06-26
Locations
4 sites across 1 country: Sweden
Source: ClinicalTrials.gov record NCT05118919. Inclusion in this directory is not an endorsement.