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

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.

Study Overview

• Status: Recruiting
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Biological: BGP-014; Biological: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Petra J Lierud; Phone Number: +46 8 724504400; Email: petra.jones.lierud@biogaiapharma.com

Study Locations

• Sweden
  • Linköping, Sweden
    • Recruiting
    • Department of Gastroenterology and Hepatology, Linköping University Hospital
  • Stockholm, Sweden
    • Recruiting
    • Gastroenterology Department, Danderyds Hospital
  • Stockholm, Sweden
    • Recruiting
    • Gastroenterology Department, Ersta Hospital
  • Uppsala, Sweden
    • Recruiting
    • Department of Medical Sciences Gastroenterology and Hepatology, Uppsala University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

1. Involvement in any investigational drug or device study within 30 days prior to this study
2. Known intolerance of 5-ASA or sulphasalazine medications
3. Biologics or FMT treatment less than 12 weeks before screening
4. No 5-ASA or steroid topical treatment is allowed
5. Antibiotic treatment < 1 month prior the study
6. Unable to maintain stable dose of NSAIDs and PPIs
7. Evidence of on-going extensive colitis
8. Fever, defined as a temperature of >38.5 °C, at Visit 1
9. Anaemia, Hb value below 100
10. Evidence of on-going toxic megacolon
11. Presence of obstructive diseases of the gastrointestinal system
12. Any clinically significant concomitant disease that might interfere with patient safety
13. Unwilling to withdraw probiotic supplements. Yoghurts without supplemented bacteria are permitted
14. Pregnant
15. Planned abdominal surgery
16. Judged unable by the physician to comprehend information regarding the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Biological: Placebo; Oral capsule
EXPERIMENTAL: Active	Biological: BGP-014; Oral capsule containing lyophilised Lactobacillus reuteri

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency and severity of adverse events	The primary objective is to evaluate the safety and tolerability of BGP-014.	Up to 10 weeks

Collaborators and Investigators

• Sponsor: BioGaia Pharma AB
• Investigators: Principal Investigator: Per M Hellström, Professor, Uppsala University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 9, 2022
• Primary Completion (ANTICIPATED): December 1, 2023
• Study Completion (ANTICIPATED): December 1, 2023

Study Registration Dates

• First Submitted: October 26, 2021
• First Submitted That Met QC Criteria: November 2, 2021
• First Posted (ACTUAL): November 12, 2021

Study Record Updates

• Last Update Posted (ESTIMATE): February 14, 2023
• Last Update Submitted That Met QC Criteria: February 13, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: AUCH-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No