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

NCT05118919 | Completed Phase 1

• 1 other identifier: AUCH-1
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 4

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.

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• Frequency and severity of adverse events

  The primary objective is to evaluate the safety and tolerability of BGP-014.

  Up to 10 weeks

Study Arms (2)

Active

EXPERIMENTAL

Biological: BGP-014

Placebo

PLACEBO COMPARATOR

Biological: Placebo

Interventions

BGP-014 BIOLOGICAL

Oral capsule containing lyophilised Lactobacillus reuteri

Active

Placebo BIOLOGICAL

Oral capsule

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• BioGaia Pharma AB: lead

Study Sites (4)

Department of Gastroenterology and Hepatology, Linköping University Hospital

Linköping, Sweden

Location

Gastroenterology Department, Danderyds Hospital

Stockholm, Sweden

Location

Gastroenterology Department, Ersta Hospital

Stockholm, Sweden

Location

Department of Medical Sciences Gastroenterology and Hepatology, Uppsala University Hospital

Uppsala, Sweden

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Per M Hellström, Professor

  Uppsala University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2021
• First Posted: November 12, 2021
• Study Start: February 9, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: June 26, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

SE (4)