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The Effects of Bifidobacterium Breve Bif195 for Small Intestinal Crohn's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04842149
Recruitment Status : Recruiting
First Posted : April 13, 2021
Last Update Posted : June 4, 2021
Sponsor:
Collaborator:
Chr Hansen
Information provided by (Responsible Party):
Andreas Munk Petersen, Hvidovre University Hospital

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Crohn Disease Dietary Supplement: Bif195 capsules Dietary Supplement: Placebo capsules Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Bifidobacterium Breve Bif195 for Small Intestinal Crohn's Disease: a Double-blind, Randomized, Placebo-controlled Study
Actual Study Start Date : May 21, 2021
Estimated Primary Completion Date : April 30, 2024
Estimated Study Completion Date : November 30, 2030

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Bif195 capsules
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.
 Dietary Supplement: Bif195 capsules
1 capsule daily for 8 weeks
Placebo Comparator: Placebo capsules
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.
 Dietary Supplement: Placebo capsules
1 capsule daily for 8 weeks


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Change in fecal calprotectin level from baseline at 8 weeks [ Time Frame: 8 weeks ]
    measured from a fecal sample

  2. Change in severity of symptoms from baseline measured by Harvey-Bradshaw index (HBI) at 8 weeks [ Time Frame: 8 weeks ]
    HBI is a disease activity index for Crohns disease and consists of clinical parameters

  3. Change in quality of life from baseline measured by Inflammatory Bowel Disease Questionnaire (IBDQ) Questionnaire Scores at 8 weeks [ Time Frame: 8 weeks ]
    The IBDQ is a widely used instrument to assess QoL among IBD patients and consists of 32 questionaire

  4. 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 ]
    measured by intestinal ultrasound (IUS)

  5. Adverse and severe adverse events [ Time Frame: 16 weeks ]
    Registered, if any events. Reported according to IHC-GCP


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04842149


Contacts
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Contact: Ida MB Grønbæk, MD 004530366773 ida.marie.bruun.groenbaek@regionh.dk
Contact: Andreas M Petersen, MD, PhD 004538626199 andreas.munk.petersen@regionh.dk

Locations
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Denmark
Gastrounit, Copenhagen University Hospital Hvidovre Recruiting
Hvidovre, Copenhagen, Denmark, 2650
Contact: Andreas M Petersen, MD, ph.d    004538625960    andreas.munk.petersen@regionh.dk   
Contact: Ida M Grønbæk, MD    +4538623862    andreas.munk.petersen@regionh.dk   
Principal Investigator: Andreas M Petersen, MD, ph.d.         
Sponsors and Collaborators
Hvidovre University Hospital
Chr Hansen
Investigators
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Principal Investigator: Andreas M Petersen, MD, PhD Gastrounit, Copenhagen University Hospital Hvidovre, Copenhagen
More Information
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Responsible Party: Andreas Munk Petersen, Principal Investigator, MD, PhD, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT04842149    
Other Study ID Numbers: H-20068527
First Posted: April 13, 2021    Key Record Dates
Last Update Posted: June 4, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Andreas Munk Petersen, Hvidovre University Hospital:
Probiotics
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases