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

Ulcerative Colitis Clinical Trial

Official title:

A Randomised Placebo-controlled Safety Study of Lactobacillus Reuteri BGP-014 in Patients With Mild to Moderate Ulcerative Colitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05118919
• Other study ID #: AUCH-1
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: February 9, 2022
• Est. completion date: December 2023

Study information

• Verified date: February 2023
• Source: BioGaia Pharma AB
• Contact: Petra J Lierud
• Phone: +46 8 724504400
• Email: petra.jones.lierud[@]biogaiapharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Biological:
• BGP-014
Oral capsule containing lyophilised Lactobacillus reuteri
• Placebo
Oral capsule

Locations

Country	Name	City	State
Sweden	Department of Gastroenterology and Hepatology, Linköping University Hospital	Linköping
Sweden	Gastroenterology Department, Danderyds Hospital	Stockholm
Sweden	Gastroenterology Department, Ersta Hospital	Stockholm
Sweden	Department of Medical Sciences Gastroenterology and Hepatology, Uppsala University Hospital	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
BioGaia Pharma AB

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency and severity of adverse events	The primary objective is to evaluate the safety and tolerability of BGP-014.	Up to 10 weeks