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

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