Back to resultsA Safety Study of Lactobacillus Reuteri BGP-014 in Patients With Ulcerative Colitis
Primary Purpose
Ulcerative Colitis
Status
Recruiting
Phase
Phase 1
Locations
Sweden
Study Type
Interventional
Intervention
BGP-014
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Ulcerative Colitis
Eligibility Criteria
Inclusion Criteria:
- The subject has given written consent to participate in the study.
- Diagnosed previously with UC (> 6 months earlier) determined by clinical and endoscopic histopathology (pathology showing chronic inflammatory changes). ≥1 documented previous flare-up and with last resolved flare >3 months away.
- Active UC determined by sigmoidoscopy before randomisation of study (baseline) and defined as a total Mayo index score of 4 to 10 points (endoscopic subscore ≥1, rectal bleeding ≥1).
- Permitted concomitant SoC medications include: Oral aminosalicylates (5-ASA), with a stable dose (1.6-4.8g/ day) for at least 12 days prior to screening, Visit 1. Steroids (dose ≤15mg at screening, Visit 1) with further tapering of dose in accordance with SoC until steroid tx termination. Immunomodulator, as: 6-Mercaptopurine, Azathioprine, Methotrexate (Stable dose for > 12 weeks prior to screening, Visit 1).
- Females of childbearing potential must use effective contraceptives
Exclusion Criteria:
- Involvement in any investigational drug or device study within 30 days prior to this study
- Known intolerance of 5-ASA or sulphasalazine medications
- Biologics or FMT treatment less than 12 weeks before screening
- No 5-ASA or steroid topical treatment is allowed
- Antibiotic treatment < 1 month prior the study
- Unable to maintain stable dose of NSAIDs and PPIs
- Evidence of on-going extensive colitis
- Fever, defined as a temperature of >38.5 °C, at Visit 1
- Anaemia, Hb value below 100
- Evidence of on-going toxic megacolon
- Presence of obstructive diseases of the gastrointestinal system
- Any clinically significant concomitant disease that might interfere with patient safety
- Unwilling to withdraw probiotic supplements. Yoghurts without supplemented bacteria are permitted
- Pregnant
- Planned abdominal surgery
- Judged unable by the physician to comprehend information regarding the study
Sites / Locations
- Department of Gastroenterology and Hepatology, Linköping University HospitalRecruiting
- Gastroenterology Department, Danderyds HospitalRecruiting
- Gastroenterology Department, Ersta HospitalRecruiting
- Department of Medical Sciences Gastroenterology and Hepatology, Uppsala University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Active
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Frequency and severity of adverse events
The primary objective is to evaluate the safety and tolerability of BGP-014.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05118919
Brief Title
A Safety Study of Lactobacillus Reuteri BGP-014 in Patients With Ulcerative Colitis
Official Title
A Randomised Placebo-controlled Safety Study of Lactobacillus Reuteri BGP-014 in Patients With Mild to Moderate Ulcerative Colitis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 9, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BioGaia Pharma AB
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
BGP-014
Intervention Description
Oral capsule containing lyophilised Lactobacillus reuteri
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Oral capsule
Primary Outcome Measure Information:
Title
Frequency and severity of adverse events
Description
The primary objective is to evaluate the safety and tolerability of BGP-014.
Time Frame
Up to 10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The subject has given written consent to participate in the study.
Diagnosed previously with UC (> 6 months earlier) determined by clinical and endoscopic histopathology (pathology showing chronic inflammatory changes). ≥1 documented previous flare-up and with last resolved flare >3 months away.
Active UC determined by sigmoidoscopy before randomisation of study (baseline) and defined as a total Mayo index score of 4 to 10 points (endoscopic subscore ≥1, rectal bleeding ≥1).
Permitted concomitant SoC medications include: Oral aminosalicylates (5-ASA), with a stable dose (1.6-4.8g/ day) for at least 12 days prior to screening, Visit 1. Steroids (dose ≤15mg at screening, Visit 1) with further tapering of dose in accordance with SoC until steroid tx termination. Immunomodulator, as: 6-Mercaptopurine, Azathioprine, Methotrexate (Stable dose for > 12 weeks prior to screening, Visit 1).
Females of childbearing potential must use effective contraceptives
Exclusion Criteria:
Involvement in any investigational drug or device study within 30 days prior to this study
Known intolerance of 5-ASA or sulphasalazine medications
Biologics or FMT treatment less than 12 weeks before screening
No 5-ASA or steroid topical treatment is allowed
Antibiotic treatment < 1 month prior the study
Unable to maintain stable dose of NSAIDs and PPIs
Evidence of on-going extensive colitis
Fever, defined as a temperature of >38.5 °C, at Visit 1
Anaemia, Hb value below 100
Evidence of on-going toxic megacolon
Presence of obstructive diseases of the gastrointestinal system
Any clinically significant concomitant disease that might interfere with patient safety
Unwilling to withdraw probiotic supplements. Yoghurts without supplemented bacteria are permitted
Pregnant
Planned abdominal surgery
Judged unable by the physician to comprehend information regarding the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Petra J Lierud
Phone
+46 8 724504400
Email
petra.jones.lierud@biogaiapharma.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Per M Hellström, Professor
Organizational Affiliation
Uppsala University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Gastroenterology and Hepatology, Linköping University Hospital
City
Linköping
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Gastroenterology Department, Danderyds Hospital
City
Stockholm
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Gastroenterology Department, Ersta Hospital
City
Stockholm
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Department of Medical Sciences Gastroenterology and Hepatology, Uppsala University Hospital
City
Uppsala
Country
Sweden
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
A Safety Study of Lactobacillus Reuteri BGP-014 in Patients With Ulcerative Colitis
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