Crohn DiseaseNCT04842149
The Effects of Bifidobacterium Breve Bif195 for Small Intestinal Crohn's Disease
A study testing Bif195 capsules in people with Crohn Disease, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
The purpose of this study is to investigate if the probiotic Bifidobacterium breve Bif195 (Bif195) will result in improvement in clinical outcome in patients with small intestinal Crohn's disease. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Crohn Disease
- What is being tested?
- Bif195 capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteDenmark
- Study dates
- 21 May 2021to 30 Nov 2024
- Phase
- Interventional
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with small intestinal CD
- Fecal calprotectin ≥ 250 ug/g
- IUS evidence of small bowel inflammation with wall thickness ≥ 4 mm
- At least 3 months af stable medical treatment
- Able to read and speak Danish
Who cannot join
- Positive rectal swab for pathogenic microorganisms
- Use of antibiotics, probiotics and systemic glucocorticosteroids within 4 weeks prior to inclusion
- Participation in other clinical trials within 30 days prior to inclusion
- Pregnancy, planned pregnancy or breast feeding
- Psychiatric disease
- Abuse of alcohol or drugs
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Gastrounit, Copenhagen University Hospital Hvidovre
Hvidovre, Copenhagen, 2650
About this study
Official title: The Effects of Bifidobacterium Breve Bif195 for Small Intestinal Crohn's Disease: a Double-blind, Randomized, Placebo-controlled Study
The purpose of this study is to investigate if the probiotic Bifidobacterium breve Bif195 (Bif195) will result in improvement in clinical outcome in patients with small intestinal Crohn's disease.
Read the detailed description
Crohn's disease (CD) is a chronic inflammatory bowel disease (IBD) with an incidence rate at 11/100 000 per year in Denmark.
The disease can potentially affect the entire gastrointestinal tract, though the most common affected area is terminal ileum and the adjacent part of colon.
CD is a result of both genetic and environmental factors together with the intestinal microbiota, however the precise etiology is unclear.
A change of the intestinal microbiota with a reduced occurrence of e.g. Bacteroides species, Firmicutes and the anti-inflammatory bacteria Faecalibacterium prausnitzii is found in CD patients compared to healthy controls. Also a reduction of the mucosa-associated Bifidobacteria has been associated with the risk of mucosal inflammation.
The hypothesis that an imbalance between potentially beneficial and pathogenic bacteria contribute to the pathogenesis of IBD, including CD, has led to the suggestion that manipulation of the microbiota may be an attractive target for therapeutic interventions in IBD.
A new probiotic bacterium, Bifidobacterium breve Bif195 (Bif195) has been identified and has shown great effects on preventing enteropathy and ulcers on the gut mucosa in healthy volunteers given acetylsalicylic acid (13), and thereby Bif195 has also shown a potential in reducing gut permeability defects. This bacterium has not yet been investigated in CD patients.
- Conditions
- Crohn Disease
- Being tested
- Bif195 capsules, Placebo capsules
- Keywords
- Probiotics
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bif195 capsulesDietary supplement
1 capsule daily for 8 weeks
Placebo capsulesDietary supplement
1 capsule daily for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Bif195 capsules | Active comparator | The capsule will contain approximately 15*10^9 CFU of Bif195 per day. Excipients: Microcrystalline Cellulose 6 mg per capsule, Magnesium Stearate 1.5 mg per capsule, Maltodextrin 277.8 mg per capsule, and Sodium Ascorbate 14.7 mg per capsule. Receives: Dietary Supplement: Bif195 capsules |
| Placebo capsules | Placebo comparator | The capsule contain only excipients: Microcrystalline Cellulose 6 mg per capsule, Magnesium Stearate 1.5 mg per capsule, Maltodextrin 277.8 mg per capsule, and Sodium Ascorbate 14.7 mg per capsule. Receives: Dietary Supplement: Placebo capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Bowel Wall Thickness (BWT) from baseline measured by intestinal ultrasound (IUS) at 8 weeks
IUS will be performed in the non-fasting patient lying in supine position with a high-end ultrasound machine (Siemens Sequoia) with 10L4 transducer.
Measured: 8 weeks
Secondary outcomes (5)
Change in fecal calprotectin level from baseline at 8 weeks
measured from a fecal sample
Measured: 8 weeks
Change in severity of symptoms from baseline measured by Harvey-Bradshaw index (HBI) at 8 weeks
HBI is a disease activity index for Crohns disease and consists of clinical parameters
Measured: 8 weeks
Change in quality of life from baseline measured by Inflammatory Bowel Disease Questionnaire (IBDQ) Questionnaire Scores at 8 weeks
The IBDQ is a widely used instrument to assess QoL among IBD patients and consists of 32 questionaire
Measured: 8 weeks
The change from baseline on Color Doppler Imaging Score (0-3) including inflammatory fat and ulceration (yes/no) at 8 weeks
measured by intestinal ultrasound (IUS)
Measured: 8 weeks
Adverse and severe adverse events
Registered, if any events. Reported according to IHC-GCP
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2021
- Study start21 May 2021
- Primary completion30 Apr 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Crohn DiseaseStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Novonesis
- Responsible party
- Principal investigator, Andreas Munk Petersen, Hvidovre University Hospital
- Investigators
- Andreas M Petersen, MD, PhD, Principal investigator, Gastrounit, Copenhagen University Hospital Hvidovre, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04842149
- Sponsor's protocol ID
- H-20068527
- Status last verified
- Oct 2023
- First submitted
- 8 Apr 2021
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gronbaek IMB, Halkjaer SI, Mollerup S, Hansen EH, Paulsen SJ, Engel S, Theede K, Wilkens R, Boysen T, Petersen AM. The effects of probiotic treatment with Bifidobacterium breve, Bif195 for small intestinal Crohn's disease and the gut microbiome: results from a randomised, double-blind, placebo-controlled trial. Gut Pathog. 2025 Apr 9;17(1):19. doi: 10.1186/s13099-025-00692-6.
PubMed 40205497
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Bifidobacterium Breve Bif195 for Small Intestinal Crohn's Disease: a Double-blind, Randomized, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT04842149
- Acronym / sponsor ID
- H-20068527
- Conditions
- Crohn Disease
- Keywords
- Probiotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Collaborators
- Novonesis
- Study start
- 21 May 2021 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 13 Apr 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 purpose of this study is to investigate if the probiotic Bifidobacterium breve Bif195 (Bif195) will result in improvement in clinical outcome in patients with small intestinal Crohn's disease.
Detailed description
Crohn's disease (CD) is a chronic inflammatory bowel disease (IBD) with an incidence rate at 11/100 000 per year in Denmark.
The disease can potentially affect the entire gastrointestinal tract, though the most common affected area is terminal ileum and the adjacent part of colon.
CD is a result of both genetic and environmental factors together with the intestinal microbiota, however the precise etiology is unclear.
A change of the intestinal microbiota with a reduced occurrence of e.g. Bacteroides species, Firmicutes and the anti-inflammatory bacteria Faecalibacterium prausnitzii is found in CD patients compared to healthy controls. Also a reduction of the mucosa-associated Bifidobacteria has been associated with the risk of mucosal inflammation.
The hypothesis that an imbalance between potentially beneficial and pathogenic bacteria contribute to the pathogenesis of IBD, including CD, has led to the suggestion that manipulation of the microbiota may be an attractive target for therapeutic interventions in IBD.
A new probiotic bacterium, Bifidobacterium breve Bif195 (Bif195) has been identified and has shown great effects on preventing enteropathy and ulcers on the gut mucosa in healthy volunteers given acetylsalicylic acid (13), and thereby Bif195 has also shown a potential in reducing gut permeability defects. This bacterium has not yet been investigated in CD patients.
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 |
|---|---|---|
| Bif195 capsules | Active comparator | Dietary Supplement: Bif195 capsulesThe capsule will contain approximately 15*10^9 CFU of Bif195 per day. Excipients: Microcrystalline Cellulose 6 mg per capsule, Magnesium Stearate 1.5 mg per capsule, Maltodextrin 277.8 mg per capsule, and Sodium Ascorbate 14.7 mg per capsule. |
| Placebo capsules | Placebo comparator | Dietary Supplement: Placebo capsulesThe capsule contain only excipients: Microcrystalline Cellulose 6 mg per capsule, Magnesium Stearate 1.5 mg per capsule, Maltodextrin 277.8 mg per capsule, and Sodium Ascorbate 14.7 mg per capsule. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed with small intestinal CD
- Fecal calprotectin ≥ 250 ug/g
- IUS evidence of small bowel inflammation with wall thickness ≥ 4 mm
- At least 3 months af stable medical treatment
- Able to read and speak Danish
Key exclusion criteria (6 listed)
- Positive rectal swab for pathogenic microorganisms
- Use of antibiotics, probiotics and systemic glucocorticosteroids within 4 weeks prior to inclusion
- Participation in other clinical trials within 30 days prior to inclusion
- Pregnancy, planned pregnancy or breast feeding
- Psychiatric disease
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 |
|---|---|---|
| Bif195 capsules1 capsule daily for 8 weeks | Dietary supplement | Bif195 capsules |
| Placebo capsules1 capsule daily for 8 weeks | Dietary supplement | Placebo capsules |
Primary outcome
Change in Bowel Wall Thickness (BWT) from baseline measured by intestinal ultrasound (IUS) at 8 weeks
Time frame: 8 weeks
IUS will be performed in the non-fasting patient lying in supine position with a high-end ultrasound machine (Siemens Sequoia) with 10L4 transducer.
5 secondary outcomes
Change in fecal calprotectin level from baseline at 8 weeks
Time frame: 8 weeks
Change in severity of symptoms from baseline measured by Harvey-Bradshaw index (HBI) at 8 weeks
Time frame: 8 weeks
Change in quality of life from baseline measured by Inflammatory Bowel Disease Questionnaire (IBDQ) Questionnaire Scores at 8 weeks
Time frame: 8 weeks
The change from baseline on Color Doppler Imaging Score (0-3) including inflammatory fat and ulceration (yes/no) at 8 weeks
Time frame: 8 weeks
Adverse and severe adverse events
Time frame: 16 weeks
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 30 May 2025.
- Derived from this study: PubMed 40205497Gronbaek IMB, Halkjaer SI, Mollerup S, Hansen EH, Paulsen SJ, Engel S, Theede K, Wilkens R, Boysen T, Petersen AM. The effects of probiotic treatment with Bifidobacterium breve, Bif195 for small intestinal Crohn's disease and the gut microbiome: results from a randomised, double-blind, placebo-controlled trial. Gut Pathog. 2025 Apr 9;17(1):19. doi: 10.1186/s13099-025-00692-6.
- 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.
Andreas M Petersen, MD, PhD principal investigator
Gastrounit, Copenhagen University Hospital Hvidovre, Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bif195 capsules in people with Crohn Disease, run by Hvidovre University Hospital at 1 site in Denmark.
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 6 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 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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.
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?
Change in Bowel Wall Thickness (BWT) from baseline measured by intestinal ultrasound (IUS) at 8 weeks (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04842149, which also lists 1 linked publication.
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 30 May 2025.