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

Study Purpose

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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05118919
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

BioGaia Pharma AB
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Per M Hellström, Professor
Principal Investigator Affiliation Uppsala University Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Sweden
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Ulcerative Colitis
Arms & Interventions

Arms

Experimental: Active

Placebo Comparator: Placebo

Interventions

Biological: - BGP-014

Oral capsule containing lyophilised Lactobacillus reuteri

Biological: - Placebo

Oral capsule

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Stockholm, Sweden

Status

Recruiting

Address

Gastroenterology Department, Danderyds Hospital

Stockholm, ,

Stockholm, Sweden

Status

Recruiting

Address

Gastroenterology Department, Ersta Hospital

Stockholm, ,

Uppsala, Sweden

Status

Recruiting

Address

Department of Medical Sciences Gastroenterology and Hepatology, Uppsala University Hospital

Uppsala, ,

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