Ulcerative ColitisPhase 1/2NCT05118919
A Safety Study of Lactobacillus Reuteri BGP-014 in Patients With Ulcerative Colitis
A Phase 1/2 study testing BGP-014 in people with Ulcerative Colitis, run by BioGaia Pharma AB at 4 sites in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- BGP-014
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 4 sitesSweden
- Study dates
- 9 Feb 2022to 31 Dec 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
4 sites in 1 country.
Sweden4 sites
Department of Gastroenterology and Hepatology, Linköping University Hospital
Linköping
Gastroenterology Department, Danderyds Hospital
Stockholm
Gastroenterology Department, Ersta Hospital
Stockholm
Department of Medical Sciences Gastroenterology and Hepatology, Uppsala University Hospital
Uppsala
About this study
Official title: A Randomised Placebo-controlled Safety Study of Lactobacillus Reuteri BGP-014 in Patients With Mild to Moderate Ulcerative Colitis
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
- Being tested
- BGP-014, Placebo
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BGP-014Biological
Oral capsule containing lyophilised Lactobacillus reuteri
PlaceboBiological
Oral capsule
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Not described Receives: Biological: BGP-014 |
| Placebo | Placebo comparator | Not described Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and severity of adverse events
The primary objective is to evaluate the safety and tolerability of BGP-014.
Measured: Up to 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2021
- Study start9 Feb 2022
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioGaia Pharma AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Per M Hellström, Professor, Principal investigator, Uppsala University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05118919
- Sponsor's protocol ID
- AUCH-1
- Status last verified
- Dec 2024
- First submitted
- 26 Oct 2021
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Placebo-controlled Safety Study of Lactobacillus Reuteri BGP-014 in Patients With Mild to Moderate Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT05118919
- Acronym / sponsor ID
- AUCH-1
- Conditions
- Ulcerative Colitis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- BioGaia Pharma ABIndustry (pharma, biotech, devices)
- Study start
- 9 Feb 2022 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 12 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Biological: BGP-014 |
| Placebo | Placebo comparator | Biological: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BGP-014Oral capsule containing lyophilised Lactobacillus reuteri | Biological | Active |
| PlaceboOral capsule | Biological | Placebo |
Primary outcome
Frequency and severity of adverse events
Time frame: Up to 10 weeks
The primary objective is to evaluate the safety and tolerability of BGP-014.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Per M Hellström, Professor principal investigator
Uppsala University Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BGP-014 in people with Ulcerative Colitis, run by BioGaia Pharma AB at 4 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency and severity of adverse events (time frame: Up to 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2025.