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

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.

Study Overview

• Status: Completed
• Conditions: Crohn Disease
• Intervention / Treatment: Dietary supplement: Bif195 capsules; Dietary supplement: Placebo capsules

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 Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen
    • Hvidovre, Copenhagen, Denmark, 2650
      • Gastrounit, Copenhagen University Hospital Hvidovre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in fecal calprotectin level from baseline at 8 weeks	measured from a fecal sample	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	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	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)	8 weeks
Adverse and severe adverse events	Registered, if any events. Reported according to IHC-GCP	16 weeks

Collaborators and Investigators

• Sponsor: Hvidovre University Hospital
• Collaborators: Chr Hansen
• Investigators: Principal Investigator: Andreas M Petersen, MD, PhD, Gastrounit, Copenhagen University Hospital Hvidovre, Copenhagen

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2021
• Primary Completion (Actual): April 30, 2024
• Study Completion (Actual): November 30, 2024

Study Registration Dates

• First Submitted: April 8, 2021
• First Submitted That Met QC Criteria: April 8, 2021
• First Posted (Actual): April 13, 2021

Study Record Updates

• Last Update Posted (Actual): May 30, 2025
• Last Update Submitted That Met QC Criteria: May 26, 2025
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Probiotics
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: H-20068527

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No