Irritable Bowel SyndromeNCT04808271
The Effects of Bifidobacterium Breve Bif195 for Diarrhea-predominant Irritable Bowel Syndrome
A study testing Bifidobacterium breve Bif195 in people with Irritable Bowel Syndrome, run by Hvidovre University Hospital at 2 sites 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 diarrhea-predominant irritable bowel syndrome (IBS). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Bifidobacterium breve Bif195
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 2 sitesDenmark
- Study dates
- 16 Apr 2021to 9 May 2023
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosed with IBS-D defined as more than one-fourth (25%) of bowel movements with Bristol Stool Scale Types 6-7 and less than one-fourth (25%) with Types 1-2
- Fulfill Rome IV diagnostic criteria for IBS
- Moderate to severe disease activity (IBS-SSS ≥175)
- Able to read and speak Danish
- Normal colonoscopy (performed within 1 year) if the patient had blood in stool
Who cannot join
- Other chronic gastro intestinal diseases including lactose intolerance and coeliac disease
- Fecal calprotectin ≥50 mg/kg
- Fecal sample positive for enteropathogenic microorganisms
- Surgical interventions in the GI region (except for appendectomy, hernia repair, cholecystectomy and gynecological and urological procedures)
- Psychiatric disorder
- Abuse of alcohol or drugs
Show all 10Show fewer
- Medications except birth control pills, hormone supplements, allergies/asthma agents, blood pressure and cholesterol-lowering agents, proton pump inhibitors and non-prescription medicines; abnormal colonoscopy findings
- Pregnancy, planned pregnancy or breastfeeding females
- Ingestion of probiotics or antibiotics <4 weeks before the inclusion
- Abnormal screening biochemistry
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Hvidovre Hospital, Copenhagen University
Hvidovre, Copenhagen, 2650
Copenhagen University Hospital Hvidovre
Hvidovre, 2650
About this study
Official title: The Effects of Bifidobacterium Breve Bif195 for Diarrhea-predominant Irritable Bowel Syndrome: 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 diarrhea-predominant irritable bowel syndrome (IBS).
Read the detailed description
IBS is the most frequently diagnosed gastrointestinal disease and also the most common cause of referrals to gastroenterology departments in Denmark.
The possibilities for treatment for IBS are limited. Treatment strategies that involve the microbiota provide symptom relief in some IBS patients. Several studies have demonstrated that the composition of the gut microbiota in IBS patients is different from healthy controls.
Probiotic interventions has shown promising results, but it currently remains unknown which probiotics are effective and which are not.
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, and thereby Bif195 has also shown a potential in reducing gut permeability defects. This bacterium has not yet been investigated in IBS patients.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Bifidobacterium breve Bif195, Placebo
- Keywords
- Probiotics
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bifidobacterium breve Bif195Dietary supplement
1 capsule daily for 8 weeks
PlaceboDietary 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: Bifidobacterium breve Bif195 |
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in IBS symptoms from baseline measured by IBS-severity scoring system (IBS-SSS) at 8 weeks
IBS-SSS is a composite score of abdominal pain, number of days with abdominal pain, bloating/distension, satisfaction with bowel habits, and IBS-related quality of life. Each measure is rated from 0 to 100, with total scores ranging from 0 (best) to 500 (worst).
Measured: 8 weeks
Secondary outcomes (4)
Change in quality of life from baseline measured by Irritable Bowel Syndrome-Quality of Life (IBS-QOL) Questionnaire Scores at 8 weeks
The IBS-QoL questionnaire consists of 34 items, each with a 5-point response scale. The 34 items are based on the following eight variables: health worries, food avoidance, body image, dysphoria, interference with activity, social reactions, sexual activity and relationships. The IBS-QoL score will be transformed into a 0-100 scale using the formula: total score = (sum of the items-34/170) ×100. Low score (best)
Measured: 8 weeks
Changes from baseline in bowel habits at 8 weeks
measured by frequency/day and Bristol Stool Form Scale. The Bristol Stool Form Scale is divided into seven categories were a low value indicate constipation and a high value indicate diarrhoea.
Measured: 8 weeks
Change from baseline in abdominal pain at 8 weeks
Measured by a VAS scale from 0-10. 0 = no pain, 10 = worst pain
Measured: 8 weeks
Adverse 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 posted22 Mar 2021
- Study start16 Apr 2021
- Primary completion9 May 2023
- Study completion9 May 2023
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 Irritable Bowel SyndromeStudies 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
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chr Hansen
- Responsible party
- Principal investigator, Andreas Munk Petersen, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04808271
- Sponsor's protocol ID
- H-20060730
- Status last verified
- Jul 2023
- First submitted
- 4 Mar 2021
- Last updated
- 6 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gronbaek IMB, Halkjaer SI, Hansen EH, Mollerup S, Paulsen SJ, Konrad CV, Engel S, Bulinska-Balas M, Wellejus A, Haaber AB, Christensen AH, Engsbro AL, Petersen AM. Eight weeks of treatment with probiotic Bifidobacterium breve, Bif195 lowers fatigue scores in patients with diarrhoea-predominant irritable bowel syndrome: results from a randomised, clinical trial. Front Nutr. 2026 Jan 21;12:1701341. doi: 10.3389/fnut.2025.1701341. eCollection 2025.
PubMed 41648756
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Bifidobacterium Breve Bif195 for Diarrhea-predominant Irritable Bowel Syndrome: a Double-blind, Randomized, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT04808271
- Acronym / sponsor ID
- H-20060730
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Probiotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Collaborators
- Chr Hansen
- Study start
- 16 Apr 2021 (actual)
- Primary completion
- 9 May 2023 (actual)
- Study completion
- 9 May 2023 (actual)
- First posted
- 22 Mar 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 diarrhea-predominant irritable bowel syndrome (IBS).
Detailed description
IBS is the most frequently diagnosed gastrointestinal disease and also the most common cause of referrals to gastroenterology departments in Denmark.
The possibilities for treatment for IBS are limited. Treatment strategies that involve the microbiota provide symptom relief in some IBS patients. Several studies have demonstrated that the composition of the gut microbiota in IBS patients is different from healthy controls.
Probiotic interventions has shown promising results, but it currently remains unknown which probiotics are effective and which are not.
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, and thereby Bif195 has also shown a potential in reducing gut permeability defects. This bacterium has not yet been investigated in IBS 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: Bifidobacterium breve Bif195The 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: PlaceboThe 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 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Diagnosed with IBS-D defined as more than one-fourth (25%) of bowel movements with Bristol Stool Scale Types 6-7 and less than one-fourth (25%) with Types 1-2
- Fulfill Rome IV diagnostic criteria for IBS
- Moderate to severe disease activity (IBS-SSS ≥175)
- Able to read and speak Danish
- Normal colonoscopy (performed within 1 year) if the patient had blood in stool
Key exclusion criteria (10 listed)
- Other chronic gastro intestinal diseases including lactose intolerance and coeliac disease
- Fecal calprotectin ≥50 mg/kg
- Fecal sample positive for enteropathogenic microorganisms
- Surgical interventions in the GI region (except for appendectomy, hernia repair, cholecystectomy and gynecological and urological procedures)
- Psychiatric disorder
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 |
|---|---|---|
| Bifidobacterium breve Bif1951 capsule daily for 8 weeks | Dietary supplement | Bif195 capsules |
| Placebo1 capsule daily for 8 weeks | Dietary supplement | Placebo capsules |
Primary outcome
Change in IBS symptoms from baseline measured by IBS-severity scoring system (IBS-SSS) at 8 weeks
Time frame: 8 weeks
IBS-SSS is a composite score of abdominal pain, number of days with abdominal pain, bloating/distension, satisfaction with bowel habits, and IBS-related quality of life. Each measure is rated from 0 to 100, with total scores ranging from 0 (best) to 500 (worst).
4 secondary outcomes
Change in quality of life from baseline measured by Irritable Bowel Syndrome-Quality of Life (IBS-QOL) Questionnaire Scores at 8 weeks
Time frame: 8 weeks
Changes from baseline in bowel habits at 8 weeks
Time frame: 8 weeks
Change from baseline in abdominal pain at 8 weeks
Time frame: 8 weeks
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 6 Jul 2023.
- Derived from this study: PubMed 41648756Gronbaek IMB, Halkjaer SI, Hansen EH, Mollerup S, Paulsen SJ, Konrad CV, Engel S, Bulinska-Balas M, Wellejus A, Haaber AB, Christensen AH, Engsbro AL, Petersen AM. Eight weeks of treatment with probiotic Bifidobacterium breve, Bif195 lowers fatigue scores in patients with diarrhoea-predominant irritable bowel syndrome: results from a randomised, clinical trial. Front Nutr. 2026 Jan 21;12:1701341. doi: 10.3389/fnut.2025.1701341. eCollection 2025.
- Individual participant dataSharing planned: No
Related trials for Irritable Bowel Syndrome
RecruitingObservational study
Abdominal Symptoms and Rosacea: An Observational Study on the Association Between Irritable Bowel Syndrome (IBS) and the Gut-Skin Axis
IBS (Irritable Bowel Syndrome), Rosacea
Recruiting
Stress Reduction and Lifestyle Modification in Irritable Bowel Syndrome Patients
Irritable Bowel Syndrome
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)
Irritable Bowel Syndrome, Diarrhea
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bifidobacterium breve Bif195 in people with Irritable Bowel Syndrome, run by Hvidovre University Hospital at 2 sites 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 10 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 6 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 IBS symptoms from baseline measured by IBS-severity scoring system (IBS-SSS) 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 NCT04808271, 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 6 Jul 2023.