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

Crohn Disease Clinical Trial

Official title:

The Effects of Bifidobacterium Breve Bif195 for Small Intestinal Crohn's Disease: a Double-blind, Randomized, Placebo-controlled Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04842149
• Other study ID #: H-20068527
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 21, 2021
• Est. completion date: November 30, 2030

Study information

• Verified date: October 2023
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 33
• Est. completion date: November 30, 2030
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease

Intervention

Dietary Supplement:
• Bif195 capsules
1 capsule daily for 8 weeks
• Placebo capsules
1 capsule daily for 8 weeks

Locations

Country	Name	City	State
Denmark	Gastrounit, Copenhagen University Hospital Hvidovre	Hvidovre	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Hvidovre University Hospital	Chr Hansen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in fecal calprotectin level from baseline at 8 weeks	measured from a fecal sample	8 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	Adverse and severe adverse events	Registered, if any events. Reported according to IHC-GCP	16 weeks