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A Safety Study of Lactobacillus Reuteri BGP-014 in Patients With Ulcerative Colitis

NCT05118919 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2025-06-26

No results posted yet for this study

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

BIOLOGICAL

BGP-014

Oral capsule containing lyophilised Lactobacillus reuteri

BIOLOGICAL

Placebo

Oral capsule

Sponsors & Collaborators

  • BioGaia Pharma AB

    lead INDUSTRY

Principal Investigators

  • Per M Hellström, Professor · Uppsala University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-09
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Sweden

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05118919 on ClinicalTrials.gov