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 andendoscopic histopathology (pathology showing chronic inflammatory changes). ≥1documented previous flare-up and with last resolved flare >3 months away.

• Active UC determined by sigmoidoscopy before randomisation of study (baseline) anddefined 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 astable 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 inaccordance with SoC until steroid tx termination. Immunomodulator, as: 6-Mercaptopurine, Azathioprine, Methotrexate (Stable dose for > 12 weeks prior toscreening, 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 thisstudy

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 patientsafety

13. Unwilling to withdraw probiotic supplements. Yoghurts without supplemented bacteriaare permitted

14. Pregnant

15. Planned abdominal surgery

16. Judged unable by the physician to comprehend information regarding the study